Podcasts about DCTS

The Dauphin County Technical School (DCTS) Student-Run Restaurant, known as DC TASTE, offers a unique dining experience where guests can enjoy meals prepared entirely by each year’s Culinary Arts senior class. Hear from students Michael Osborne-Griffy and Illeiona ("Illy") Johnson, both seniors at DCTS as well as Chef Claire Dacko, Culinary Arts Instructor at DCTS. Support WITF: https://www.witf.org/support/give-now/See omnystudio.com/listener for privacy information.

2025-01-31 Hosts Jane Myles (DTRA) and Michelle Shogren (Innovate In What You Do!) were joined by Rebecca Kottschade (Mayo Clinic) and Caroline Redeker (Advanced Clinical) to share about the work they led at DTRA around Roles and Responsibilities when using decentralized elements in clinical trials.Sites are overburdened with technology and role ambiguity as the use of DCT methods in clinical trials evolve. It is often unclear to sites whose responsibility it is to do what when using DCT methods. Site considerations for implementation of DCTs include training, ongoing support, cost, risk, responsibility, logistics, integrations, and teaching patients how to use and enable the DCT offerings. This team developed a set of questions to be applied before site selection and at site activation to aid in study planning.The newly released work is now available on the DTRA website at: https://www.dtra.org/roles-and-responsibilities-colabYou can join TGIF-DTRA Sessions live on LinkedIn Live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

The FDA's 2024 guidance on decentralized clinical trials (DCTs) has the potential to transform clinical research, particularly in oncology. While many still view DCTs as either fully virtual or fully in-person, the guidance promotes a hybrid approach, blending traditional and decentralized elements. This flexibility may help smaller sites participate alongside large academic medical centers, making trials more accessible to rural and underserved areas.However, challenges remain, including regulatory complexities, patient safety concerns, and infrastructure demands—especially for oncology studies, which are inherently intricate and costly. The FDA's choice to issue nonbinding guidance rather than enforceable regulations reflects a desire for progress without lengthy regulatory delays, even as it leaves questions about enforcement and compliance.The guidance hints at using healthcare providers innovatively, potentially improving recruitment and trial access. Still, the reliance on guidance rather than regulations raises concerns about consistency, as auditors often treat nonbinding recommendations as de facto rules.Ultimately, while the DCT model offers promise, particularly for oncology, its success hinges on balancing flexibility with clear standards, empowering both large and small research sites to deliver innovative treatments effectively.Support the show

Subscriber-only episodeWe explore the rapidly evolving role of artificial intelligence (AI) in clinical trial research design. He discusses how AI is reshaping the pharmaceutical landscape and highlights key areas identified by the FDA where AI is expected to make a significant impact.Darshan delves into the transformative power of digital health technologies, which enable real-time patient monitoring and enhance adherence to treatment protocols. These technologies not only improve patient safety but also provide critical data that can refine trial outcomes. The episode also emphasizes the benefits of decentralized clinical trials, which allow participants to engage from home, expanding recruitment and increasing diversity in research.Furthermore, Darshan explains the importance of real-world data, which can uncover valuable insights into drug effectiveness and safety outside traditional trial settings. However, he raises concerns about privacy and data interoperability, particularly for smaller trial sites that may lack advanced technologies.Ultimately, the integration of AI into clinical trials promises a more efficient, inclusive, and accurate research process, leading to faster therapy development and improved patient outcomes. Darshan concludes by reminding listeners to stay informed about these advancements and their regulatory implications.If you enjoyed this episode, be sure to subscribe, rate, and leave a review for more insights into the evolving trends in pharmaceuticals and clinical research.

Subscriber-only episodeIn this episode, we're diving into a crucial topic: the role of artificial intelligence in clinical research and the evolving landscape of data privacy laws that will impact every step of the process.In this episode, we'll be unpacking insights from Dr. ElZarrad, the FDA's Deputy Director for the Office of Medical Policy, on how AI is shaping clinical trial design and research. We'll also explore how AI can speed up trials, enhance patient recruitment, and even predict outcomes with greater accuracy. But with these advancements comes a significant responsibility, especially when it comes to patient data privacy. We'll talk about how laws like HIPAA, GDPR, CCPA, and others play a crucial role in safeguarding sensitive patient data at every step of AI development.If you're as passionate about the future of clinical research as we are, hit **like, subscribe, and share—it really helps grow the channel!Now, let's start from the beginning: Why is AI such a game-changer in clinical research? Well, it enables researchers to analyze vast datasets quickly, allowing for more tailored, personalized therapies. It's a breakthrough for precision medicine and personalized healthcare, and if we get this right, it could transform the entire industry. Dr. Dr. ElZarrad from the FDA highlights how AI can identify eligible patients more effectively and analyze real-time data, speeding up clinical trials significantly. AI also supports the rise of decentralized trials, where patients can participate remotely, making trials more accessible and diverse. This shift will be crucial, especially given the recent clinical trials guidance and the growing role of telemedicine.Of course, with this technological power comes the critical need for transparency and patient consent. AI relies heavily on sensitive data like medical histories, genetic information, and treatment responses. We'll also dive into the different layers of privacy laws—from data collection to tracking and communication regulations—and discuss why ensuring compliance at every stage is essential for maintaining trust and avoiding major legal pitfalls.Stay tuned as we break down these complexities and offer practical tips for staying compliant in this ever-evolving space.

In this episode, Isaac Rodriguez- Chavez and I discuss the impact of DCTs on sponsor relationships, CROs, and industry dynamics with the FDA. We discuss,1. How will DCTs impact sponsor relationships with CROs? 2. How do small CROs and sponsors adapt to emerging trends? 3. How do new trends impact industry relationships with the FDA?4. Does DCT allows the FDA to advise sponsors? 5. What is the role of technology in DCTs? 6. How do DCTs reduce the cost of bringing drugs to the market? 7.  What are the risks and advantages of DCTs? 8. What are the initial risks of DCTs? 9.  Does the FDA even have jurisdiction over patient privacy? Support the show

2024-10-10 Hosts Craig Lipset, Dr. Amir Kalali, and Jane Myles were joined by Matt Veatch and Aaron Kamauu, hosts of the Real World Wednesday's Club on Clubhouse. We joined forces for a TGIF-DTRA + RWW Crossover Episode! With the release of the FDA Draft Guidance on Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice, it was the perfect topic to bring together the DCT and RWE community for a conversation around this guidance. We discussed why this guidance was aligned to RWE, the distinctions between decentralized, pragmatic, point-of-care trials, and real-world evidence, and how RCTs and DCTs can drive access for all patients.Read the guidance here --> https://www.fda.gov/media/181871/downloadYou can join TGIF-DTRA Sessions live on LinkedIn Live Audio on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

Dr. Shaalan Beg and Dr. Arturo Loaiza-Bonilla discuss the potential of artificial intelligence to assist with patient recruitment and clinical trial matching using real-world data and next-generation sequencing results. TRANSCRIPT Dr. Shaalan Beg: Hello, and welcome to the ASCO Daily News Podcast. I'm Dr. Shaalan Beg, your guest host for the podcast today. I'm an adjunct associate professor at UT Southwestern's Simmons Comprehensive Cancer Center in Dallas and senior advisor for clinical research at the National Cancer Institute. On today's episode, we will be discussing the promise of artificial intelligence to improve patient recruitment in clinical trials and advanced clinical research. Joining me for this discussion is Dr. Arturo Loaiza-Bonilla, the medical director of oncology research at Capital Health in Philadelphia. He's also the co-founder and chief medical officer at Massive Bio, an AI-driven platform that matches patients with clinical trials and novel therapies.  Our full disclosures are available in the transcript of this episode.   Arturo, it's great to have you on the podcast today.  Dr. Arturo Loaiza-Bonilla: Thanks so much, Shaalan. It's great to be here and talking to you today.  Dr. Shaalan Beg: So we're all familiar with the limitations and inefficiencies in patient recruitment for clinical trials, but there are exciting new technologies that are addressing these challenges. Your group developed a first-in-class, AI-enabled matching system that's designed to automate and expedite processes using real-world data and integrating next-generation sequencing results into the algorithm. You presented work at the ASCO Annual Meeting this year where you showed the benefits of AI and NGS in clinical trial matching and you reported about a twofold increase in potential patient eligibility for trials. Can you tell us more about this study?  Dr. Arturo Loaiza-Bonilla: Absolutely. And this is just part of the work that we have seen over the last several years, trying to overcome challenges that are coming because of all these, as you mentioned, inefficiencies and limitations, particularly in the manual patient trial matching. This is very time consuming, as all of us know; many of those in the audience as well experience it on a daily basis, and it's resource intensive. It takes specialized folks who are able to understand the nuances in oncology, and it takes, on average, even for the most experienced research coordinator or principal investigator oncologist, 25 minutes per trial. Not only on top of that, but in compound there's a lack of comprehensive genomic testing, NGS, and that complicates the process in terms of inability to know what patients are eligible for, and it can delay also the process even further.  So, to address those issues, we at Massive Bio are working with other institutions, and we're part of this … called the Precision Cancer Consortium, which is a combination of 7 of the top 20 top pharma companies in oncology, and we got them together. And let's say, okay, the only way to show something that is going to work at scale is people have to remove their silos and barriers and work as a collaborative approach. If we're going to be able to get folks tested more often and in more patients, assess for clinical trials, at least as an option, we need to understand further the data. And after a bunch of efforts that happened, and you're also seeing those efforts in CancerX and other things that we're working on together, but what we realize here is using an AI-enabled matching system to basically automate and expedite the process using what we call real-world data, which is basically data from patients that are actually currently being treated, and integrating any NGS results and comparing that to what we can potentially do manually. The idea was to do multi-trial matching, because if we do it for one study, yeah, it will be interesting, but it will not show the potential applicability in the real world.  So with all that background, the tool itself, just to give you the punchline of it, was proven highly effective in terms of efficiency. We were able to increase the number of potential matches, and not only that, but reducing the time to the matching. So basically, instead of spending 25 minutes, it could be done in a matter of seconds. And when you compound all that across multiple clinical trials, in this case, it was several sponsors coming together, we were able to reduce the manual effort of seeing patients and testing for clinical trials to basically 1 hour when it would have otherwise taken a ridiculous amount of time. And it was quantified as 19,500 hours of manual work, compared to 1 hour done by the system to uniquely match a cohort of about 5,600 patients that came into the platform. And this was across 23 trials. Now imagine if we can do it for the 14,000 clinical trials currently in clinicaltrials.gov.   So for us, this kind of was an eye-opening situation that if we can increase not only the efficiency but find even more trials by integrating comprehensive genomic testing, which in this case was a twofold increase in eligibility for clinical trials, that gives us not only the opportunity for optimized processes using AI but also a call to action that there is still a lot of under-genotyping. And I know American Cancer Society and ASCO and many others are working hard on getting that into fruition, but we need to have systems that remind us that certain patients are not tested yet and that can improve not only real patients, but the R&D and the process of innovation in the future. Dr. Shaalan Beg: Yeah, it's always an important reminder that even some of the highest impact IT solutions or AI solutions are most effective if they can be integrated into our normal clinical processes and into the normal workflow that we have in our clinics to help clinicians do their work quickly and more efficiently. Can you talk about how, over the last few years, the availability of NGS data in our electronic medical record (EMR) has evolved and whether that's evolving for the better? And what are some next steps in terms of making that data available at EMR so that such solutions can then pull that data out and do clinical trial matching?  Dr. Arturo Loaiza-Bonilla: Yes. So one of the things that we have seen over the last couple of years is because of the applicability of the 21st Century Cures Act, there is less “information blocking,” which is patients not being able to access their information in real time. Now, with the appearance of health exchanges, with patient-centric approaches, which is something that many innovators, including ours, are trying to apply, it's really becoming more relevant. So it's not only helping us to find the patients when they really need to get tested, but also is giving us the opportunity to put those patients into the right treatment pathway when found. Something that's still a challenge and I think we can work by being more collaborative once again – is my dream – is having these pre-screening hubs where no matter where you are in your cancer journey, you just go into that funnel and then are able to see, “Okay, you are in the second-line setting for non-small cell lung cancer, EGFR-mutated. Now, do you have a meta amplification, then you go for this study or this trial. Oh, you haven't been tested yet. You should get tested. You're a pancreas cancer patient who is KRAS wild type; well, there is a significant chance that you may have a biomarker because that's where most patients are enriched for.” So having that opportunity to at scale, just for the whole country, to get those patients access to that information, I think is crucial for the future of oncology. And I think you working at the NCI, more than most, know how the impact of that can help for those underrepresented patients to get more access to better treatment options and whatnot. And we can activate clinical trials as well in new models, decentralized models, adjusting time models, all those things can be leveraged by using biomarker testing in real time. Identification when the patient really needs a trial option or a medication option, because the data is telling us when to activate that in real time. Dr. Shaalan Beg: And identifying the patient for a potential clinical trial is one challenge. In oncology, given a lot of our trials, we are looking to enroll people at a specific time in their disease journey. So we call it first-line or second-line or third-line, becomes the next challenge. So just knowing someone has mutation number 1, 2, or 3 isn't enough to say they would be eligible for a second-line BRAF X, Y and Z mutation at a given trial. I've heard you talk a lot about this last-mile navigation for people once you've identified that they may be a soft match for a clinical trial. Can you talk about what you've seen in the ecosystem being developed on how AI is helping both clinics and patients navigate this last mile from the time they're identified for a clinical trial to the time they actually receive cycle 1, day 1? Dr. Arturo Loaiza-Bonilla: Yeah, absolutely. And that is such a critical point because, as you know, we have helped tons of patients getting trial options in thousands of cases. But even my own patients, I give them a report for trial options and they're like, “Okay, I still need help.” And we have been talking with ASCO, with the American Cancer Society, and many other very good teams, and what we see as an opportunity in technology here is leveraging those cancer journeys to know when the patient really has the opportunity to enroll in a trial, because this is a very dynamic environment. Not only the patient's condition changes because their cancer progresses, the hemoglobin changes, the cancer moves from one place to the other, and there's nuances in between, but also new medications are coming up, studies open and close, sites open and close.  So having this information as a hub, as what we call a command center, is the key to make this happen. And we can use the same tools that we use for Uber or for Instacart or whichever thing you want to do; it's already the same concept. When you need groceries, you don't need groceries every day. But Amazon gives you a ding that's like, “Well, I think you may be running out of milk,” because they already know how often you buy it, or just having the data behind the scenes of how typically these, in this case, patient journeys, may manifest based on the biomarker. So let's say a smoldering multiple myeloma is not the same across. One patient with biomarkers that make them very high risk, the risk of progressing to a multiple myeloma, first-line treatment-eligible patient is going to be much different than someone who has better risk cytogenetics. So using that tool to optimize the cancer journeys of those patients and being able to notify them in real time of new trial options, and also knowing when the patient really has that disease progression so there's a time of activation for trial matching again, the same way you get a credit score for buying a house, then you know exactly what options are in front of you at that very moment. And that is the last-mile component, which is going to be key. What we have seen that we feel is important to invest on, and we have invested heavily on it, is that until the patient doesn't sign the consent form for the clinical trial, that patient is completely unknown to most people. The site doesn't know them because they haven't been there, and they may be there, but they don't know about the options sometimes. But no one's going to invest in getting that patient to the finish line. There's a lot of support for patients on trials, but not before they enroll on trials. And we feel that this is a big opportunity to really exponentially grow the chances of patients enrolling in trials if we support them all the way from the very time they get diagnosed with cancer in any setting. And we can help that patient on a very unique journey to find the trial options using technology. So it's very feasible. We see it once again in many other equally complex tasks, so why not do it in oncology when we have all the bonafides across wanting to do this. Dr. Shaalan Beg: Can you give examples of where you are seeing it done outside of oncology that's a model that one can replicate? Dr. Arturo Loaiza-Bonilla: I mean, oncology is the toughest use case to crack. You have experiences with DCTs in the past and all that. So the big opportunities are for patients, for example, in psychiatry, when they need certain counseling and help. We see that also in medical devices, when people have diabetes and they really need a device specifically for that unique situation, or also for patients with cardiovascular risk that they can in real time get access to novel therapeutics. And that's how they have been able to enroll so quickly. And all these GLP-1 inhibitors, all those models are really almost completely decentralized nowadays in something that we can extrapolate for oncology once we have aligned the ecosystem to make it see them. This is something that we can really revolutionize care while we manage all the complex variables that typically come with oncology uses.  Dr. Shaalan Beg: I would imagine while you translate those learnings from outside of oncology into oncology, a lot of those processes will be human and AI combination activities. And as you learn more and more, the human component becomes a smaller fraction, and the technology and the AI becomes more of a component. Are you seeing a similar transition in the clinical trial matching space as well? Dr. Arturo Loaiza-Bonilla: Yes. So that's why people say humans are going to be replaced. They're not. Patients still want to see a human face that they recognize, they trust. Even family members of mine want to hear from me, even if they are in the top place in the world. What we can change with technology are those things that are typically just friction points. In this case, information gathering, collecting records, getting the data structured in a way that we can use it for matching effectively, knowing in real time when the patient progresses, so we can really give them the chances of knowing what's available in real time. And collecting the information from all these other stakeholders. Like, is the site open? Is the budget approved for that place? Is the insurance allowing the specific … do they have e-consent? Those things can be fully automated because they're just burdensome. They're not helping anyone. And we can really make it decentralized for e-consent, for just getting a screening. They don't need to be screened at the site for something that they're going to receive standard of care. We can really change that, and that's something that we're seeing in the space that is changing, and hopefully we can translate it fully in oncology once we are getting the word out. And I think this is a good opportunity to do so. Dr. Shaalan Beg: You talked about your dream scenario for clinical trial matching. When you think about your dream scenario as a practicing oncologist, what are the AI tools that you are most excited about making their way into the clinic, either wishful thinking or practically? Dr. Arturo Loaiza-Bonilla: I typically get feedback from all over the place on doing this, and I also have my own thoughts. But I always come to this for a reason. We all became physicians and oncologists because we like being physicians. We like to talk to patients. We want to spend the time. I tell folks in my clinic, I will see a thousand patients all the time as long as I don't have to do notes, as long as I don't have to place orders. But of course, they will have to hire 1,000 people ancillary to do all the stuff that we do.  If we can go back and spend all that time that we use on alert fatigue, on clicking, on gathering things, fighting insurance, and really helping align those incentives with clinical trials and biomarker testing and really making it a mankind or a humankind situation where we're all in this really together to solve the problem, which is cancer, that will be my dream come true. So I don't have to do anything that is clerical, that is not really helping me, but I want to use that AI to liberate me from that and also use the data that is generated for better insights. I think that I know my subject of expertise, but there's so many things happening all the time that it is hard to keep up, no matter how smart you are. If the tool can give me insights that I didn't even know, then leverage that as a CME or a board certification, that would be a dream come true. Of course, I'm just dreaming here, but it's feasible. Many of these ideas, as I mentioned, they're not new. The key thing is getting them done. The innovative part is getting stuff done, because I'm sure there's a gazillion people who have the same ideas as I did, but they just don't know whom to talk to or who is going to make it happen in reality. And that's my call to action to people: Let's work together and make this happen. Dr. Shaalan Beg: Well, Arturo, thanks a lot for sharing your insights with us today on the ASCO Daily News Podcast. Dr. Arturo Loaiza-Bonilla: Well, thank you so much for the time and looking forward to having more exchanges and conversations and seeing everyone in the field. Dr. Shaalan Beg: And thank you to our listeners for your time today. You'll find a link to the studies discussed today in the transcript of this episode. And if you value the insights that you hear on the podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts.   Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Find out more about today's speakers:  Dr. Shaalan Beg    @ShaalanBeg Dr. Arturo Loaiza-Bonilla @DrBonillaOnc   Follow ASCO on social media: @ASCO on Twitter   ASCO on Facebook   ASCO on LinkedIn     Disclosures:    Dr. Arturo Loaiza-Bonilla: Leadership: Massive Bio Stock and Other Ownership Interests: Massive Bio Consulting or Advisory Role: Massive Bio, Bayer, PSI, BrightInsight, Cardinal Health, Pfizer, Eisai, AstraZeneca, Regeneron, Verily, Medscape Speakers' Bureau: Guardant Health, Bayer, Amgen, Ipsen, AstraZeneca/Daiichi Sankyo, Natera   Dr. Shaalan Beg:    Consulting or Advisory Role: Ispen, Cancer Commons, Foundation Medicine, Genmab/Seagen    Speakers' Bureau: Sirtex    Research Funding (An Immediate Family Member): ImmuneSensor Therapeutics    Research Funding (Institution): Bristol-Myers Squibb, Tolero Pharmaceuticals, Delfi Diagnostics, Merck, Merck Serono, AstraZeneca/MedImmune

2024-06-07 Host Craig Lipset was joined by a special guest host, Jean Sposaro (BMS) for our session around Sponsor Experience Implementing DCTs. TransCelerate Bio Pharma conducted a survey in 2023 to better understand the collective experience of TransCelerate members deploying decentralized clinical trial (DCT) elements beyond the COVID-19 pandemic. Ashley Butler (TransCelerate) and Joachim Lovin (Novo Nordisk) joined us for the discussion. TransCelerate's recently released whitepaper can be found here --> https://www.transceleratebiopharmainc.com/wp-content/uploads/2024/04/Sponsor-Experience-Implementing-Decentralized-Clinical-Trial-DCT-Elements-DCT-Implementation-Survey-Results_vFINAL-1.pdfYou can join TGIF-DTRA Sessions live on LinkedIn Live Audio on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

2022-10-21 Hosts Craig Lipset and Jane Myles chatted with John Hall (CluePoints), Joe Dustin (previously Medable) and Daniel DiJohnson (Parexel) about risk based quality monitoring and how it fits into DCTs.You can join TGIF-DTRA Sessions live on LinkedIn Live Audio on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership options and our work at www.dtra.org.

Trials@Home is a €39 million, pan-European public private partnership of the EU's Innovative Medicines Initiative, focused on defining the best practices to conduct decentralised clinical trials (DCTs). In this Vital Health Podcast, Duane Schulthess speaks with Kim Hawkins, Global Head of Clinical Project Operations at Sanofi, and the Co-Project Lead of the Trials@Home consortium. Kim outlines how Trials@Home is applying new innovative approaches to DCTs to evaluate different operational models of DCTs in RADIAL, the project's pan-European proof of concept study. As well, Kim Hawkins describes how one core mission of the project is placing patient choices and opinions at the centre of decision making and implementation.See omnystudio.com/listener for privacy information.

2022-10-14 Host Craig Lipset was joined by a powerhouse of site leaders for a great conversation around what sites need to make DCTs a success. Casey Orvin (CenExel), Lori Wright (ERG), Irfan Khan (Circuit Clinical), Jimmy Bechtl (SCRS), and Paul Evans (Velocity Clinical Research) joined for the conversation.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2024-04-12 Hosts Amir Kalali, MD and Jane Myles were joined by Stacey Adam, Vice President, Science Partnerships for the Foundation for National Institute of Health. She shared about her experiences with platform trials, DCT methods, and how they are working to drive innovation further for patients.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2024-04-05 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by several members of the research community for a robust discussion about how to find evidence of impact, our efforts to make it available in the DTRA Library, and ways we can continue working to find this evidence to drive adoption of DCTs.The DTRA Library can be accessed here and is available to all. We are asking for you to make submissions of additional case studies, white papers, articles, and more so we can continue to grow the library for all.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

For more information, visit DPHARMconference.com. 

2024-03-15 Hosts Craig Lipset and Jane Myles were joined by Jonathan Ernst (PCM Trials) and Ghazala Kabani (Integrity ClinOps Consulting) for a discussion around the growing interest and excitement for decentralized clinical trials in Pakistan.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

In this episode, hosts Payal Nanavati, Jodi Daniel, and Cara Tenenbaum talk to Ben Moscovitch, Devon Adams, and Noah Goodson about recent policy developments on decentralized clinical trials (DCTs). They also discuss the Crowell Health Solutions' white paper* on DCTs, which issues to federal agencies a number of policy recommendations to advance DCT adoption and increase clinical trial diversity. This podcast episode features the following speakers: Jodi Daniel is a Managing Director of Crowell Health Solutions and also is a partner in Crowell's DC office, who leads the firm's Digital Health Practice. She previously spent 15 years at the Department of Health and Human Services (HHS). Cara Tenenbaum is a Consultant with Crowell Health Solutions, leads Strathmore Health, and has extensive experience in health policy and patient advocacy. She worked at the U.S. Food and Drug Administration (FDA) for six years. Ben Moscovitch leads Amazon Web Services (AWS) healthcare and life sciences public policy efforts and focuses on policy reforms to improve health data interoperability and clinical research. Devon Adams is a Senior Policy Analyst at the American Cancer Society Cancer Action Network, the nonpartisan advocacy affiliate of the American Cancer Society. He works on policy related to cancer research, device and drug development, precision medicine, and clinical trials. Noah Goodson, Ph.D. is the Principal of Strategy & Advisory at THREAD Research. He spends his day supporting pharmaceutical, biotech, and medical device companies in the design and execution of clinical trials. White Paper: https://www.crowell.com/a/web/vFgM2vJzbE4wsuVyJ5o1py/advancing-adoption-of-decentralized-clinical-trials-rationale-current-state-and-policy-recommendations.pdf  

2023-12-01 DTRA Initiative Leaders Munther Baara (Edetek) and Moulik Shah (Advanced Clinical) to discuss Data Connectivity and Interoperability in DCTs and how it can be done with study teams now.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2022-03-25 Join hosts Craig Lipset and Amir Kalali alongside MaryAnne Rizk (Rizk Management Advisors) and Rohit Nambisan (Lokavant) to discuss how we maintain quality in trials and what is the role of data & analytics in this area.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

This episode of WCG Talks Trials, hosted by Kelly Fitzgerald, Executive IRB Chair and Vice President of IBC Affairs at WCG, dives into the topic of diversity and inclusion with technology in decentralized clinical trials (DCTs). The episode explores the transformative opportunities that DCTs present for addressing diversity gaps in clinical research. The discussion features a panel of experts, including Otis Johnson, former Chief Diversity, Inclusion, and Sustainability Officer at Clario; Archana Sah, a seasoned clinical development leader with a focus on oncology and healthcare technology; and Ken McCann, a physician with a background in pediatrics and a keen interest in social determinants of health. The panelists share insights on how DCTs can improve accessibility, overcome barriers, and enhance representation in clinical trials, emphasizing the potential for these trials to be a game-changer in making clinical research more equitable and inclusive. Guests:Archana Sah MS (Pharm.) PMP Otis Johnson, PhD, MPAKen McCann, MD 

2022-06-24 Our hosts were joined by Julie Lin and Kim Hawkins (Sanofi), and Alexander Pastuszak (Contraline, previously Vault Health) to discuss whether or not the use of DCT methods has to be "all or nothing."Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-11-03 Join host Craig Lipset and special guest host Angela Radcliffe for a great session with Madeline Geday (Astellas) around the Business Case for DCTs.Hear how and why including the DCT model as part of protocol design supports organizations to find the right balance operationally and makes the patients' lives easierLearn about the wide range of factors that need to be considered when determining the risk vs the benefit to a studyDiscuss how to determine what will work in your organization by using a decision-making process that finds the right methodologies and technologies which are dependent on the therapeutic and patient populationFollow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-10-13 TGIF-DCT mashup with Real World Wednesdays! We were thrilled to welcome The hosts of Real World Wednesdays (https://lnkd.in/eMTGG25j) -- Matt Veatch and Aaron Kamauu MD MS MPH join us for a discussion on how Real World Data intersects with decentralized trials. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2022-04-01 Join us to learn about what a Research Site today and how decentralized methods can be part of some or many parts of a trial. Hosts Craig and Amir were joined by Lori Wright and Andria Chastain (Evolution Research Group) and Samantha Eells (Lightship)

For the 1 in 5 Americans living in rural or frontier communities, clinical trial participation poses significant challenges due to travel burden, reduced healthcare access, and lack of awareness of trial opportunities. Through a novel collaboration with rural-focused researchers, University of Washington is looking to tackle some of the toughest aspects of initiating decentralized trials in these remote regions to extend opportunity equity.Hosts Craig Lipset, Jane Myles, and Amir Kalali were joined by Elizabeth Johnson, PhD, MS-CRM, RN (Montana State University-Bozeman), Christopher Goss (University of WA), and Margaret Rosenfeld (Seattle Children's) for the discussion.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Ever imagined the immense potential that decentralized clinical trials (DCTs) could unlock for patients and sponsors? This week, we're going on a deep dive into the world of DCTs with our esteemed guest, Ewa Lindqvist, a trailblazer in this space. Brace yourself for an enlightening conversation about how DCTs are paving the way for increased access to new treatments and real-time data for physicians, all while slashing costs and inefficiencies.Resistance to DCTs, stemming from technology fears and competency gaps, is a significant hurdle. However, our discussion with Ewa sheds light on how regulators have transformed into allies in this journey. We also unveil Thread, an innovative app poised to streamline DCTs, with its impressive capacity to monitor compliance, safety, efficacy, and much more. So, if you've been apprehensive about DCTs, it's time to shed those fears!In our final segment, we touch on the pivotal role of convenience in clinical trials. Learn how Thread is leveraging technology to synchronize wearables and EDC data, thus driving efficient clinical trial processes. Also, we explore the integral role of patient advocacy organizations in ensuring DCTs are offered to patients. This conversation promises to revolutionize your understanding of clinical trials and the extraordinary potential of decentralization. Tune in and get ready to be amazed.Guest: Ewa Lindqvist________Reach out to Sam Parnell and Ivanna RosendalJoin the conversation on our LinkedIn page

Brian's LinkedIn: https://www.linkedin.com/in/brianellerman/Veeva Site Vault: https://sites.veeva.com/Versatrial: http://www.versatrial.ioCRIO: http://www.clinicalresearch.ioInato: https://go.inato.com/3VnSro61nHealth: https://1nhealth.com/Join me at my conference! http://www.saveoursites.comText Me: (949) 415-6256My podcast is Random Musings From The Clinical Trials GuruListen on Spotify: https://open.spotify.com/show/7JF6FNvoLnBpfIrLNCcg7aGET THE BOOK! https://www.amazon.com/Comprehensive-Guide-Clinical-Research-Practical/dp/1090349521/ref=sr_1_1?keywords=Dan+Sfera&qid=1691974540&s=audible&sr=1-1-catcorrText "guru" to 855-942-5288 to join VIP list!My blog: http://www.TheClinicalTrialsGuru.comMy CRO and Site Network: http://www.DSCScro.comMy CRA Academy: http://www.TheCRAacademy.comMy CRC Academy: http://www.TheCRCacademy.comLatinos In Clinical Research: http://www.LatinosinClinicalResearch.comThe University Of Clinical Research: https://www.theuniversityofclinicalresearch.com/My TikTok: DanSferaLifeBoost Coffee: https://lifeboostcoffee.com/products/biotics-brew?_pos=2&_sid=576df78bc&_ss=r&nb_platform=shareasale

2022-05-13 Join us to hear from Ardy Arianpour (SEQSTER) and Marjorie Tan-Thronson (Salesforce) to hear about the use case, barriers, and challenges around whether or not patients can bring their EHR data into prospective trials and what it means for patients.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

In today's podcast, Medable Chief Science Officer Dr. Pamela Tenaerts joins host Jonah Comstock to discuss the current state of regulations in DCTs and what's currently lacking.

2023-04-15 Jennifer Price (THREAD) and Jeremy Wyatt (ActiGraph) joined our hosts Amir Kalali and Craig Lipset to discuss wearables and how they can be used in DCTs. Areas of focus were how to properly support the patient, interpreting the data, and the barriers in the adoption of wearables.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2022-05-20 We discussed all things reimbursement for clinical trial participants. We covered not only financial compensation but also returning value to participants though sharing data & evidence and more. Our hosts Craig Lipset and Amir Kalali were joined by Adam Samson (Walgreens) Ellyn Getz (CSL Behring), and Wayne Baker (Elite Research Network). Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2022-02-11 Join us to hear about the measurements and endpoints we need to be measuring as we take on DCTs and how we need to modernize those tools to capture the data we need. Our hosts Amir and Craig were joined by Samantha Reed and Andy Coravos (HumanFirst) for the discussion.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

For Topic Tuesday, the guys are asked if DCTs and great automatics have made manuals irrelevant and less fun? They debate project cars for Jake, who wants to become an annoying car historian. Social media questions ask for one thing the guys would change on the CTR, do they regularly use adaptive cruise control, and has Mercedes watered down its AMG badge now?   Please rate + review us on iTunes, and subscribe to our two YouTube channels. Write us with your Car Debates, Car Conclusions, and Topic Tuesdays at everydaydrivertv@gmail.com or everydaydriver.com. Don't forget to share the podcast with your car enthusiast friends! Learn more about your ad choices. Visit megaphone.fm/adchoices

2023-07-14 AI, LLMs, and ChatGPT are all the rage right now - how might they impact DCTs? We'll discuss on Clubhouse tomorrow at 12:00 PM ET. Our hosts wil be joined by Ritesh Patel (FINN Partners) Richie Etwaru (Mobeus) for the conversation. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-07-07 Join us as we learn about the regulatory, legal, provacy, and cultural insights for DCTs that are part of DTRAs Global Conduct Map. Our hosts Craig, Amir, and Jane were joined by team members Tom Brazier (mdgroup), Jennifer Turcotte, and Claudine Paccio (DTRA) for the discussion.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

In this episode, Medtech Insight spoke to three decentralized clinical trial experts at Hogan Lovells: partner Kristin Zielinski Duggan, partner Blake Wilson and associate Stephanie Agu. We discussed the ins and outs of the draft, what pieces of the guidance still might need clarification, and how they expect to see the industry change as DCTS become mainstream.

2023-06-23 Now that we've all reviewed the Draft FDA Guidance around DCTs, what would you do if you had a magic wand? If you were the decision maker, how would you take what was offered in the guidance and go further? Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Jonathan Andrus (CRIO) and Dylan Bechtle (The Janssen Pharmaceutical Companies of Johnson & Johnson) for the discussion.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

- Ghosn Sues Nissan for $1 Billion - Luca de Meo to Run Renault and Ampere - BMW M Declares DCTs Are Dead - Buick EV Starts at $26,500 in China - Rivian Holds Parking Lot Sale - Hyundai Dramatically Ups EV Investment - GM Pours Nearly $1 Billion Into HD Diesels - Stellantis and Foxconn to Make Chips - BorgWarner Pivots to EV Portfolio

- Ghosn Sues Nissan for $1 Billion - Luca de Meo to Run Renault and Ampere - BMW M Declares DCTs Are Dead - Buick EV Starts at $26,500 in China - Rivian Holds Parking Lot Sale - Hyundai Dramatically Ups EV Investment - GM Pours Nearly $1 Billion Into HD Diesels - Stellantis and Foxconn to Make Chips - BorgWarner Pivots to EV PortfolioThis show is part of the Spreaker Prime Network, if you are interested in advertising on this podcast, contact us at https://www.spreaker.com/show/3270299/advertisement

2023-04-21 Join us to hear from DTRA Initiative Leaders Caroline Redeker (Advanced Clinical) and Naveen Goje (ZS) on the great work their team did to gather evidence of impact of DCTs into a data repository to promote education and adoption. Amir Kalali and Jane Myles joined for the conversation.You can find the full data repository and report here.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-06-02 Join us as we discuss the recently released FDA Draft Guidance on DCTs and its impact on the 1572 Form. Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by DTRA Co Lab Members on this topic, Becky Kottschade (Mayo Clinic) and Shaheen Limbada (Veristat) for the discussion.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Join hosts Craig Lipset and Amir Kalali as they discuss Patient Choice & Optionality in DCTs. Joined by Michelle Shogren (Innovate in what you do!), Kelly McKee (Medidata), Alexander Pastuszak (Now Contraline, preiously Vault Health), and Angela Radcliffe (BMS).Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

What are the momentum killers in clinical research and innovation? In this episode, Ted Trafford discusses key issues that can kill site momentum on clinical trials and the adoption of innovation. He dives deep into the challenges that DCTs bring to sites, the flawed protocol feasibility model, and the barriers that sites and professionals face when entering the research industry. Ted believes in great potential for innovation but recognizes the industry too often forces solutions that are looking for problems that may not exist, creating unintended risk. Listen to this episode where Ted Trafford reveals the secret to getting sites to pay attention to your trial. Click this link to the show notes, transcript, and resources: outcomesrocket.health

2023-02-03 Join us to discuss sensors and wearables in clinical trials and what the unmet needs are to execute successfully. We also discussed what it will take to drive meaningful adoption in R&D. Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Megan Parisi and Dr. Luke Koschalka (Syneos Health) to discuss more.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

2023-02-11 We discussed the Best Practices Handbook created by the Initiative Team at DTRA. This team developed a Rubric thst will aid stakeholders in evaluating DCT best practices from program planning to trial close and analysis. Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Mike DeMarco (PwC) and Dan DeBonis (EMA Wellness, formerly Signant Health) to discuss the work their team did to drive this deliverable forward for the community. You can review the Rubric at https://dtraresources.org/rubrics/.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

DCTs are more than just technology! In this episode, we discuss the evolution of decentralized trial modalities, tailoring clinical trials for the participant population, and possible solutions to regulatory challenges.

Centralize to Decentralize? New packaging? Old concepts? Risk or Innovation? Understand the future and now of Decentralized trials. In this episode, Craig Lipset talks about his professional history with DCTs sharing details and examples of lessons he learned, as well as discussing factors that he's identified within these processes that work for different instances. Craig also speaks about his current work to organize and coordinate organizations to enact changes that will help adopt decentralized research methods in healthcare. Tune in and learn from the expert about what it takes to adopt DCTs most beneficially! Click this link to the show notes, transcript, and resources: outcomesrocket.health

Este es el último programa que dedicamos a las transmisiones automáticas. Concretamente, hablaremos sobre las transmisiones DCT o de doble embrague. Seguimos con las cajas automáticas y su mantenimiento. En esta ocasión, de la mano de nuestro experto en lubricantes, Antonio Fernéndez, vamos a hablar de las transmisiones de doble embrague o DCTs. Se trata de unos sistemas peculiares que son, a la vez, cajas de cambios manuales y automáticas.

The role pharmacists play in the community is the same one they should be playing in clinical research. Community-based clinical trials in general can be better for patient care, the pharmacy as a profession, and study sponsors who have long had trouble recruiting enough patients into their studies.   Within the next decade, Gerald Finken, founder and CEO of RxE2 predicts, pharmaceutical companies will no longer be running clinical trials that exclude pharmacy professionals because it will simply be too costly and overly risky.   When shipping drugs directly to patients, as has become customary with decentralized clinical trials (DCTs), many state pharmacy laws specifically stipulate that they follow the practice of pharmacy—which includes patient counseling and patient-specific labeling.   Today we talk about ‘The Evolution of Clinical Trials and the Pharmacist's Role'  

The UK Government has launched the Developing Countries Trading Scheme in Nigeria, which will enable the country to benefit from free-duty trade on exported goods. The British Deputy High Commission, Lagos, says the DCTS offers one of the most generous sets of trading preferences in the world and demonstrates the UK's commitment to building long-term, mutually beneficial relationships with countries like Nigeria. The commission says the work is part of a wider push by the UK to drive a free trade, pro-growth agenda across the globe, using trade to drive prosperity and help eradicate poverty.This show is part of the Spreaker Prime Network, if you are interested in advertising on this podcast, contact us at https://www.spreaker.com/show/4090160/advertisement

⚡ Decentralized clinical trials aim to reduce patient burden. Decentralized clinical trials can help make research more patient-centric. Tim explains the role of decentralization, "It's fair to say that that change management component is absolutely critical in terms of the decentralized adoption, and I think, when I look ahead in terms of decentralization, I see an amazing landscape for patients and the partnerships with EmVenio and also the kind of opportunities Thermo Fisher Scientific has in really driving forward unique and collaborative solutions for the better of the patient and really focusing on reducing that patient burden."⚡ We need to make clinical trials more patient-centric. Patient-centricity is key when it comes to improving participation in clinical trials and clinical research progress overall. Tim says, "As an industry, we talk about patient-centricity and I think we embrace significant patient-centricity by taking a research site with all the research professionals on board to the patient's home."⚡ Representation in clinical trials matters. Diversity is vital to preventing and treating diseases across race and gender. Thad says, "A couple of stats recently — there was one study we supported where of the 2,500 patients that EmVenio enrolled, 65% were from underrepresented populations, and so it really showed that value there. And what we're seeing more broadly is that across the studies we support, greater than 40% of the patients we're working with come from minority populations. And so, to contrast that against industry stats of around 10% to 20% as an average, we're offering more than double the ability to reach these populations that otherwise don't have access. So I think what we're seeing is that the results are really bearing on the value that we're bringing together."

In this session, Janssen shares how they are collaboratively working with patients and sites to advance DCTs and will share engagement methodologies, what they have learned from the perspective of participants and sites, and the direction this has taken them in DCTs. Alyson Gregg, Director Patient Insights, GMA Commercial Operations, Janssen Morgan Wooten, Investigator & Patient Engagement Program Team Leader, Janssen Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

In this session recorded at DPHARM 2022, Bari Kowal, SVP & Head, Development Operations and Portfolio Management, Regeneron, moderates a panel discussion on: Examining how modernizations like the implementation of AI/ML, RWE, DE&I, DCTs impact the need for more flexibility clinical trial designBuilding protocols in tandem with study design and re-envisioning methods to execute trials Panelists include: Henry Wei, MD, Head of Development Innovation, RegeneronRinol Alaj, MBA, Senior Director, Head of Clinical Outcomes Assessment & Patient Innovation, RegeneronBill Illis, Global Head, Collaboration and Technology Strategy, Clinical Development & Analytics, Novartis 

Much like RBQM, decentralized clinical trials (DCTs) are an approach to conducting clinical trials, interacting with patients and sites, and implementing fit for purpose technologies for the collection and capture of critical data and monitoring patient safety.  The overall objective of DCTs is the facilitation is to lessen the patient burden of patients and sites, therefore increasing patient participation, while ensuring the collection and capture of critical data, such as efficacy endpoints and safety data.    In the fourth episode of the RBQM podcast series, Amy Adams, Senior Director, Clinical Operations and Cris McDavid, Director, Clinical Operations discuss some questions to ask when developing a risk-based framework for decentralized clinical trials.

In this session, panelists from pharma and healthcare share perspectives on innovations in decentralized clinical trial technologies that have and have not worked during and throughout COVID. They also discuss: How we are bringing forth trial options to people on their own terms and getting patient inputCreating flexible systems that don't increase undue burden on hospitals and sitesWhat hasn't worked and whyManaging cost and spend Speakers: Sharon Hanlon, Head, Clinical Trial Engagement & Enrolment, Bristol Myers SquibbChristina Brennan, MD, MBA, VP, Clinical Research, Northwell HealthJamie Harper, MHA, CCRP, Director, Site Engagement & Relations, WCG ClinicalRamita Tandon, Chief Clinical Trials Officer, Walgreens Health, Walgreens Boots AllianceSusan Wong, PA, Principal Quality & Compliance Manager, gRED, Genentech

Let's clarify what decentralized clinical trials are before this bubble bursts! In this episode, Hassan Kadhim, global head of clinical trial business capabilities at Bristol-Myers Squibb, takes a very sober look at decentralized clinical trials: what they mean to him, how they are evolving, and why they are here to stay. To incentivize progress around DCTs, Bristol-Myers Squibb came up with a definition for the term “decentralized clinical trial” that enlists four traditional capabilities and four up-and-coming ones, all of which Hassan explains. He discusses the design and coordination for the implementation of DCTs to collect the necessary patient data in a comfortable burdenless manner. Not all countries, organizations, or sites are ready to implement DCTs; Hassan thinks ever since COVID, the industry has changed in that way. Tune in to this episode to hear more about DCTs from Hassan and learn where they're taking the research industry! Click this link to the show notes, transcript, and resources: outcomesrocket.health

• What are the benefits of the decentralized clinical trial (DCT) model? • What are the barriers to sites and investigators participating in DCTs? • What support measures are critical to DCT success? • What is the outlook for DCTs during the coming 3 – 5 years and how can sites and investigators contribute to their evolution? Listen to a lively discussion of these questions and more, as industry experts discuss DCT and hybrid clinical trial models. Download and listen to your free podcast from Scrip, presented in partnership with ICON.

Decentralized clinical trial (DCT) technology has the opportunity to create more effective, efficient, and accessible clinical trials. Now that research sites have more experience with these systems, we also have a better understanding of their challenges and opportunities. Craig Lipset, advisor and founder of Clinical Innovation Partners and co-chair of the Decentralized Trials & Research Alliance shares what the clinical trials industry has learned about DCTs and how we can move forward together.

DCTS: Exploring The Innovative Technologies, Push For Diversity, Cybersecurity, And the Future Of Remote Trials While diversity is largely recommended by regulators today, it is quickly becoming apparent diversity is vital for successful clinical trials in the future. For sponsors to fulfil the requirements, continual exploration and use of decentralized trials (DCTs) are the obvious solutions. For more information, listen to the podcast with experts from our partner at Clario.

In this second episode in the Decentrally Speaking series, we will be discussing how pharmaceutical depots are evolving their services and operations to support both sites and patients as a critical part of decentralized trials (DCTs). Expanding geographies, ancillary procurement, and storage of investigational drugs and supplies to be shipped either direct to patient or direct to site create a complex supply chain that must be carefully managed and controlled. Join our Parexel clinical trial supplies and logistics experts who share their collective experience to ensure the right mix of solutions for conducting decentralized trials to benefit sponsors, sites, and patients within a complicated and evolving regulatory environment. Sanjay Vyas, Executive Vice President And Global Strategic Business Unit, Head For Clinical Trial Supplies And Logistics Laurie McRae, Senior Director, Solutions for Clinical Trial Supplies and Logistics Daniel Meyer, Project Manager Leader, Supply and Logistics Our Decentrally Speaking series engages with subject matter experts and thought leaders on expanding clinical access for patients through the use of decentralized trials. Join us as we also explore opportunities to operationalize DCTs across our industry.   

It's the May the 4th be with you day! In Episode 26 of #HealthTechDeals, Jessica is huddling in Boston after the American Telehealth Association conference, and has Star Wars-related trivia. There's gossip there, there's more gossip about Cerebral and its ADHD med strategy. Meanwhile a lot of copy cats in deals today with Hello Heart ($70m) for hypertension, Concert Health ($40m) for mental health, Vivian Health ($60m) for nurse staffing, Curebase ($40m) for DCTs, Mendel.ai ($40m) for NLP and Blue Spark ($40m) for RPM — all joining very crowded markets.

It's the May the 4th be with you day! In Episode 26 of #HealthTechDeals, Jessica is huddling in Boston after the American Telehealth Association conference, and has Star Wars-related trivia. There's gossip there, there's more gossip about Cerebral and its ADHD med strategy. Meanwhile a lot of copy cats in deals today with Hello Heart ($70m) for hypertension, Concert Health ($40m) for mental health, Vivian Health ($60m) for nurse staffing, Curebase ($40m) for DCTs, Mendel.ai ($40m) for NLP and Blue Spark ($40m) for RPM — all joining very crowded markets.

Today we welcome back friend of the show Jane Myles, VP Innovation at Curebase. Decentralized clinical trials are talked about so much nowadays but, all too often, we are left to guess whether they perform better or worse than hybrid and brick and mortar trials. In this episode we examine a real life example of a DCT in action including metrics against hybrid and brick and mortar sites in addition to addressing some of the myths that surround DCTs.

COVID-19 changed the clinical research landscape by proving the use and efficacy of DCTs, patient-centricity and adaptive designs. Dr Ubavka DeNoble, Executive Vice President of Biotech Operations and Senior Medical Officer of Parexel Biotech shares advice on how CMOs can think about leadership, change management and investing in new technologies such as artificial intelligence, improved data collection and system interoperability to improve patient recruitment and retention and drug development efficacy. Key Takeaways: How to lead with an eye on industry changes and flexibilityThe importance of rewarding innovation rather than standardizing a single approachObservations of successful change management throughout the COVID-19 pandemic

Noah and John talk with Kendal Whitlock, a leader in innovation and organizational change with a successful career in the pharmaceutical industry. We discuss what it takes to drive innovation within large companies and the interconnection between inclusion and decentralized clinical trials (DCTs).Find Out MoreKendal WhitlockClinical Research EvolvedNoah Goodson, PhDJohn ReitesKyle RickettsAbout the ShowOn Clinical Research Evolved, hosts Dr. Noah Goodson and John Reites talk with subject matter experts from across the life science industry to discuss the history, innovations, and future of clinical research as it evolves from ideas to actions.

Our Decentrally Speaking series engages with subject matter experts and thought leaders on expanding clinical access for patients through the use of decentralized trials (DCTs). Join us as we also explore opportunities to operationalize DCTs across our industry.   In this first series episode, we will be discussing operational experiences and best practices in optimizing inclusivity for patients from Under-Represented Communities (UCs). We'll share ideas for trial recruiting, protocol review, patient and community outreach, and on-site implementation for inclusive practices from experts: Rosamund Round, Vice President, Patient Innovation Center, Parexel, one of the world's leading global clinical research organizations (CRO). Carlos Orantes, CEO, Alcanza Clinical Research, whose purpose and mission is to defend wellness for all people through the science of clinical research with efforts that are inclusive, impactful, and outstanding.

Today we're deviating a bit from the standard podcast format and delving more deeply in to one topic – decentralized clinical trials. I feel we see a great deal of conversation around DCTs from sponsors, CROs and vendors but not as much from the sites themselves. This is my humble attempt bring the site voice a little bit more to the forefront in an increasingly overcrowded space. Our site voices today are Joy Jurnack and Dr. Viviënne van de Walle. Joy has a long and diverse career in clinical trials that includes roles as a clinical research nurse, research subject advocate, IRB member, and ACRP fellow. Joy's recent passion is now how decentralization of the clinical research enterprise can include both innovation and products available to expand, develop and implement this progress to include considering DCT as an extension of the clinical research site. Viviënne is a physician by training who studied medicine both at the University of Maastricht and at the University of Oxford. She has always combined clinical research with patient care and has been a full time principal investigator at independent clinical research sites. She co-founded and owns the independent research site PreCare Trial and Recruitment in the Netherlands. In this episode, we discuss decentralized clinical trials' influence on PI oversight, site budgets, vendors/portals, and so much more!

If you're a DCT platform founder, investor, or agency wanting to support this growing market, you won't want to miss this conversation with the person who knows more about setting up and managing DCTs than virtually anyone on the planet. Today's guest is Laura Podolsky, Esq., founding General Counsel of Science37, a startup with a valuation of $1.05B when it went public in Spring 2021. Laura currently serves some of Nixon Gwilt Law's top Life Sciences and Healthcare Innovation clients.***Bonus: Download Laura's Top 5 Friction Points for DCT Providers in the Recommended Resources section belowWhat you'll get out of this episode Why Decentralized Clinical Trials (DCT) got a boost from the pandemic—and whether this boost is likely to continue What benefits and drawbacks exist with DCT when compared to traditional clinical trials How companies which support DCTs can gain access to these trials via the platforms (think: mobile nursing agencies, patient recruitment companies, and mobile labs) What special privacy considerations are needed in DCT and how companies can adjust their processes to meet those needs What investors and sponsors look for in a DCT platform during due diligence (including a handy resource) Quotables“Decentralized Clinical Trials increase participation and decrease attrition—those alone are big selling points.” DCT pioneer Laura Podolsky on Ep14 of @DecodingHealth1 w/ @NixonGwiltLaw https://sliceofhealthcare.com/category/decoding-healthcare-innovation/ “Not only can [DCTs] end up being more convenient, easier, less burdensome for patients, all of that leads to a faster trial...which yields serious financial benefits to the sponsor.” Laura Podolsky on Ep14 of  @DecodingHealth1 w/ @NixonGwiltLaw https://sliceofhealthcare.com/category/decoding-healthcare-innovation/ “For vendors, it's important to learn about DCTs and be able to say to the operators: this is how we can make this part of the process easier.” Laura Podolsky on Ep14 of  @DecodingHealth1 w/ @NixonGwiltLaw https://sliceofhealthcare.com/category/decoding-healthcare-innovation/ “One of the great promises of DCTs  is the ability to recruit from anywhere, and that also means you have to comply with the privacy laws of all these different jurisdictions.” Laura Podolsky on Ep14 of  @DecodingHealth1 w/ @NixonGwiltLaw https://sliceofhealthcare.com/category/decoding-healthcare-innovation/ “When I'm advising on data privacy in the context of DCT, it's helpful to look at the 7 principles of GDPR because most privacy laws are trending toward those.” Laura Podolsky on Ep14 of  @DecodingHealth1 w/ @NixonGwiltLaw https://sliceofhealthcare.com/category/decoding-healthcare-innovation/ Recommended Resources Download the Top 5 Friction Points for DCT Providers here (Laura's expert advice on what processes and frameworks you need to examine in your business) Connect with Laura Podolsky on Linkedin More tips on how your privacy policies impact key partnerships with vendors and investors in this webinar replay from our Privacy team Join the ConversationAre you a digital health or health system innovator? Tell us what topics and people you'd like us to cover in future episodes:– Website – LinkedIn – Twitter – Instagram – YouTubeFollow our daily updates on LinkedIn:– Carrie – RebeccaAbout Your HostsCarrie Nixon and Rebecca Gwilt are partners at Nixon Gwilt Law, a healthcare innovation law firm exclusively serving Providers, Digital Health Companies, and Life Science Businesses seeking to transform the way we receive and experience healthcare. Find out more at NixonGwiltLaw.com. This podcast is produced by Slice of Healthcare LLC. 

About the Episode: As the COVID-19 pandemic encourages the widespread adoption of decentralized clinical trial models, there are opportunities to optimize existing processes to make clinical research easier for sites and sponsors to conduct, and for patients to participate. Jonathan Andrus, Clinical Ink, discusses his advice as a flexible data collection expert, thoughts on wider adoption of DCTs and where he thinks the future is headed.   Key Takeaways: The role of regulatory guidance, how-to's and industry examplesShifting from a "surviving" to "thriving" mentality in regards to DCTsNext steps for the industry About the Speaker: Jonathan Andrus is Chief Strategy Officer of Clinical Ink. He is responsible for driving the corporate strategic vision, communicating the plan with all those involved, executing the business initiatives, and sustaining implementation efforts. This includes driving important internal initiatives, identifying potential targets for acquisition, and other partnership opportunities to help drive the business forward. About Mobile in Clinical Trials: Mobile in Clinical Trials is the meeting place for digital R&D operations leaders who are seeking solutions to apply mobile-digital tools into clinical research.  Each year, we bring forward the latest experience-based case studies while presenting fresh ideas to advance fit for purpose, adoption and scale of remote digital solutions. For more information, click here. For more information about PharmaTalk Radio, visit theconferenceforum.org.

Decentralized trials are here to stay, says Dr. Isaac Rodriguez-Chavez, our podcast guests today. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. We are delighted to have Isaac join the podcast to discuss decentralized clinical trials and why pharma companies should embrace digital technology for the benefits of patients. A former FDA officer who was instrumental in the review and approval of digital health technology in clinical trials, Dr. Rodriguez-Chavez is now the Senior Vice President for Scientific and Clinical Affairs and Head of Strategy for Decentralized Clinical Trials for Icon. I hope you enjoy this conversation with our team member, Janet Kennedy, on the People Always, Patient Sometimes podcast.   Janet Kennedy: (00:46) I can't tell you how thrilled I am to have finally landed Isaac Rodriguez-Chavez as a guest on the People Always, Patient Sometimes podcast. He is an industry leader that is someone that everyone listens to, and it's really exciting to have him here today. He is formerly the FDA officer focusing on clinical research methodology, regulatory compliance, and medical policy development, and recently joined the private sector as the Senior Vice President of Scientific and Clinical Affairs, Head of Global Center of Excellence, DCT Strategy for PRA Health Sciences. So he's got a foot in both camps and it's going to be a very exciting conversation. Isaac, welcome to the podcast!   Isaac Rodriguez-Chavez: (01:30) Thank you, Janet for having me and all the listeners, I am delighted to be here with all of you, sharing some thoughts on information that is really, I hope, pertinent for all of us.   Janet Kennedy: (01:43) You have been very active as an FDA member and as a member of the PRA Health Sciences in promoting and discussing decentralized clinical trials, and it's time is now. However, for the one listener who might not realize who you are, I'd love to explore a little bit of your background, what work you did with the FDA, and then what made you decide to come over to the private sector. So can you tell me a little bit about your background and how you came to be where you are today?   Isaac Rodriguez-Chavez: (02:14) Absolutely. I'd be happy to do so. The FDA, I was a senior officer for clinical developing medical policy and working internally. Also leading a program on decentralized clinical trials and supporting the modernization of clinical trials in general, including the implementation of digital health technologies in modern clinical investigations. The FDA is an amazing place. And my colleagues there are really wonderful, friends more than colleagues, because the work that we do really matters and impacts the entire nation. Essentially, I was a professional consulting internally and externally on decentralized clinical trials implementation of decentralized clinical trials. I believe in the modernization of clinical research. So I am a basic scientist by training with specialties in immunology and biology, but I became a clinical scientist also by training and experience over 20 plus years ago, conducting clinical trials, doing clinical research, being a sponsor, being the auditor, being essentially in multiple capacities, engage in investigations.   Isaac Rodriguez-Chavez: (03:32) So for me, my passion is really what I discover is the direct impact on the patients and their lives, and clinical research, along with the infectious diseases, which is at the end of the generic or the bigger umbrella where my expertise lands, are the things that I like and I enjoy doing. Direct impact to patients and their lives in clinical investigations, with novel products and in infectious diseases and even in vaccines, which are also a love of my life. And that's what I did at the FDA. And then I transitioned to PRA Health Sciences to lead the strategy of a newly created global center of excellence for decentralized trials. The idea really for me was about to transition from the regulatory world and diversify into the real world in how the trials are conducted and essentially lead the strategy and implementation. We are in a transformative time in clinical research because of all of these modernization efforts that are happening building decentralized trials.   Isaac Rodriguez-Chavez: (04:43) So I ended up believer in doing things better, and for the benefit of the patients, and PRA offered me essentially the venue to do so. So I am truly excited to be here with a group of professionals that are outstanding and they believe as strongly as I do in providing essentially end to end solutions and creating partnerships with multiple vendors, so that together and in unison, we can deliver the best in class and in the field in regarding decentralized clinical trials enabled by digital health technologies. And for the benefit of the patients and with efficiencies on the trials and the steps that can represent benefits for the sponsors, for the science - benefits for everyone engaged in the clinical investigation. This is the place, right now, as you said - now is the time, now is the place - in which everyone benefits. It's positive. There are multiple advantages for everyone, so, excited to be here. And my journey has been the one of love and passion for what I do and believing in doing things better for our people everywhere.   Janet Kennedy: (05:55) I'm very interested in the three-legged stool of the organizations that are involved in clinical trials. You have, of course the FDA, you have the pharmaceutical company, and then you have the groups like PRA, the clinical research organizations, that really are much more involved in the implementation of the clinical trials. What I'm curious about is, is that stool steady? In other words is one leg, a lot shorter than the others? Are all three of these organizations moving forward at the same speed? Or do you find that maybe the CROs might be ahead of the game and trying to get pharma to catch up a little bit with decentralized clinical trials? Or are you finding that partnerships with pharmaceutical companies - that everybody is about at the same place?   Isaac Rodriguez-Chavez: (06:42) I could say I see these more as a round table with multiple legs and multiple parties being engaged. One thing that is happening right now that is historically never seen is a different type of collaborations and the level of collaborations and the frequency of the collaborations between multiple entities is unprecedented. The COVID-19 pandemic really has put everyone on the discussion table to find ways to continue the traditional clinical investigations that were happening when we were hit by the pandemic. So the way to do it was the implementation of elements of decentralization. And with that, the creation of hybrid decentralized clinical trials in which some elements of decentralization are happening, and others are still happening in the brick and mortar site - the traditional clinical research site. Now days. And what we're seeing is essentially the business beyond the pandemic. The transformation that is happening really is permanent, is driven by multiple factors, and the engagement is at all levels.   Isaac Rodriguez-Chavez: (07:58) So the industry, the regulatory agencies, the clinical research organizations, such as PRA health sciences, are really making huge efforts to work together, to drive this transformation. Of course we are in a learning curve and a learning process. All of these happened suddenly. And though we are embracing decentralized clinical trials and technologies to modernize clinical research, we're still in the transition time, we're still in the changing of how to do things. Everyone is not at the same level. Everyone's not at the same speed. There is a spectrum in terms of the uptake and implementation and racing, decentralized clinical trials and technologies; that kind of goal. Everybody's thinking about how to do it in the pharmaceutical industry, in the biopharmaceutical industry - small, mid-size, large size pharmaceutical industry - but the implementation is different. So there is a whole spectrum that can go anywhere between 20% to up to closer to 80%.   Isaac Rodriguez-Chavez: (09:08) And the surveys show that information. But everyone is having conversations and the projections are very strong, that decentralized clinical trials really will become the mainstream of clincal research within the next two to five years. So this is happening, it is irreversible, it is transformative for everyone engaged in the clinical investigation. And the conversations are happening and the collaborative work is happening between multiple parties. So I not only see the regulatory agencies and the pharmaceutical industry and the CROs; I see the vendors, I see multiple vendors engage. I see the science engaged. I see the patient advocacy groups engaged. It's really multiple entities engaged in the conduct of these kinds of investigations. And it's for the benefit of everyone, as I said.   Janet Kennedy: (10:06) So you're saying you really don't think we're going to go backwards to the way it always used to be done - that people have learned, not just that patients want a new way of participating in clinical trials, but this is actually a better way?   Isaac Rodriguez-Chavez: (10:21) Pretty much. Though decentralized clinical trials are not the universal solution for every single medical product that is going to be tested, it is very common to see decentralized clinical trials in multiple therapeutic areas, and in all phases of the clinical investigation. There are multiple reasons and benefits for doing this. Essentially, the potential for enhancing convenience to the participants is a main driver for the implementation of decentralized clinical trials, the opportunity to improve recruitment and retention of participants, participants in the ecosystems where they live - meaning their homes, their towns, their cities, their countries - and not having them to fly or travel to distant places to go to a clinical research site to participate in clinical investigations is a major advantage, is a major driver. The use of technology as never before is amazing. And though technology has been utilized in traditional clinical investigations, the uptake of technology by modern clinical trial designs is very powerful, and it's happening.   Isaac Rodriguez-Chavez: (11:41) And it's happening here to stay. The opportunity to essentially monitor participants remotely with the use of technology, the opportunity to break socioeconomic barriers and geographic barriers are very powerful. And this is all because of technology. Also, if you have technology, which is one of the elements that enable these trials, but you also make plans, proactive plans to increase diversity and inclusion, you break the geographic barriers right there. And if you optimize and you think proactively from the get-go in how to design these trials and not to retrofit a traditional trial, you have a huge potential for cost savings - something that is really appealing for the sponsors. So there is an opportunity to improve efficiencies at all levels of the modern clinical trial design, decentralized clinical trials, use technologies to enable them and maintain the quality. And the regulatory agencies, particularly the FDA, is tuned to all of this. So I think, again, this is enabled by the cities or digital health technologies are here to stay. Traditional trials, they're still exist. They will continue to exist. There will be just an increase in the use of these cities enabled by the colleges. That's what I'm saying.   Janet Kennedy: (13:10) Sometimes I feel like people oversimplify and think of decentralized clinical trials as just the use of tele-health. And yet there is so much more in your current work, or even in what you were looking at when you were at the FDA, what kind of technologies do you think enhance a clinical trial?   Isaac Rodriguez-Chavez: (13:31) There is not a universal answer for your question. Your question is very important, but essentially all technologies are important. And the key point in regards to the use of technology really is the adaptation that has to happen on that technology to support the specific needs of every clinical trial. And that is the point. Each technology has to be verified. It has to be validated to the end user. It has to be justified to measure, for example, the specific end points that are relevant for the clinical investigation that is being conducted. And it has to be usable. Nobody wants to have a two pounds watch on the wrist because it's going to be really difficult to wear that on a daily basis. So the technology has to be usable. It has to be user-friendly. It has to be something that everyone from the clinical staff, to the investigator, to the actual patients need to use in a meaningful way. So technology is here to enable the trials. Technology has to be adopted on a fit for purpose basis, according to the needs of the trial, the specific end points, the specific communication plans that are put in place, depending upon the nature of the disease that we're dealing with. There are many ways of dealing with technology and the bottom line really is to optimize it, to adapt it, and to make it meaningful fit for purpose technology that supports clinical trial. That's what it is.   Janet Kennedy: (15:14) I'm very curious to hear your thoughts on the overwhelming potential for real-world data to come into play. Not that many years ago, the data from patients was sitting in the parking lot of the clinical site where they're filling out their paper diary and going, "yeah, I think I took it that day, and I think I take it that day." And now we're in a situation where not only do we know that you've taken a medication, but we also know your blood pressure or your weight or your glucometer results, things of that sort. Well, that is an overwhelming amount of data. Are the scientists that are dealing with this data, thrilled and excited to have all of this, and is it leading to a whole new level of analysis and analytic skillsets coming into clinical trials? Or do you think people really aren't prepared to know how to manage this? Because I'm thinking from a primary care physician. If I were to turn over my Fitbit data to my primary care physician, they might go, well, what do I do with this?   Isaac Rodriguez-Chavez: (16:18) Definitely the real world data and the real world evidence are important trends that were clearly supported by our legislation. When the 21st Century Cures Act was passed in 2016. That is a different work stream and trend compared to decentralized clinical trials enabled by digital health technologies. They both have in common, the use of the real world settings to collect clinical data to assess the safety and efficacy of investigation or medical products. So in that regard, they both are really powerful. And the FDA uses real world data and real world evidence to monitor, for example, post-market safety and adverse events, and also to make regulatory decisions. And that's what they actually mentioned on the website In the real world data, real world evidence space. They also use computers and mobile devices and wearables sensors. And the idea is to gather big amounts of data - data that is related to clinical research - and that is health-related data that essentially is collected, can be collected at the clinic at the doctor's office.   Isaac Rodriguez-Chavez: (17:38) And so this data can be adapted to allow for better designs and the conduct of clinical trials and studies. And essentially is, in addition to that, it really is a way of developing more sophisticated, new analytical capabilities. And essentially the data can be applied to resolve and do analysis of medical products in ways that were not done before. The same is with decentralized clinical trials. They are conducted in the real world setting. They are utilizing all of these technologies, and there is a need to create new ways of doing data analysis. The data analysis can be done with the use of, for example, artificial intelligence, machine learning, and new ways of doing these and ways of doing it quickly in almost real time or in any real time sometimes. For example, the capacity to see in any of these two in real world evidence trials, or in these CTs an outlier detected by artificial intelligence analytics that might represent, for example, an adverse event and if their protocol that is being monitored, there is an opportunity right there to react in more real time compared to for example, a traditional clinical trial. So yes, these are modernization of clinical research happening in the real world setting with new analytics, a lot of power in place to do things in real time or almost real time. Very powerful.   Janet Kennedy: (19:24) What do you think are the challenges for implementing DCTs or decentralized clinical trials and DHTs?   Isaac Rodriguez-Chavez: (19:32) I could say because we're in a transition time, though the FDA is supporting - and strongly supporting - the implementation of decentralized clinical trials and the assessment of the safety and efficacy of clinical investigations with decentralized clinical trials, and they have a history of supporting these CTs by creating a regulatory framework. That is not the same case for own regulatory agencies in the world. The EMA is in the process of understanding, for example, in Europe the EMA developed COVID-19 related guidances to enable remote activities of trials. The EMA is partnering with the Innovative Medicine Initiative, and they have implemented a center of excellence that is called "Trials at Home" to explore the use of DHTs - or digital health technologies - in decentralized clinical trials. They are developing methods to streamline data collection, as well as to essentially understand patient recruitment and retention in Europe, and use these five trials that they have put in place to inform the development of policy that is supportive of these CTs and technologies in Europe.   Isaac Rodriguez-Chavez: (20:54) The Swedish Medical Products Agency received a grant of about 2 million Swedish, I don't remember their currency, but essentially they received a lot of money to conduct preliminary studies on decentralized clinical trials and examine the conditions and the requirements to conduct safety and efficacy studies using the CT approaches in Sweden. The Danish Medical Agency went ahead of the pack and they just issue in May of 2021, their guidance on the implementation of decentralized elements in clinical trials with medical products. And so there is a clear movement from the European regulatory agencies. In Asia, there are conversations between the regulatory agencies and multiple stakeholders to inform them on the implementation development and implementation of policies that support clinical trials. So we have a spectrum that is led by the US FDA that is really advanced in the regulatory framework that they have developed followed by Europe and the European regulatory agencies followed by the Asian regulatory agencies in the development of policies for decentralized clinical trials.   Isaac Rodriguez-Chavez: (22:20) Meanwhile, we have to go on a country basis to understand the regulatory intelligence and the possibility of deploying multiple elements of decentralization required on each study to implement decentralized clinical trials. So a major challenge really is having the harmonization of policies, procedures, the regulatory framework, the legal framework, across multiple jurisdictions to implement the CTs globally - that it stays there. Another challenge is the digital health divide; we all know and talk about the digital health divide. And so democratizing having equal access to technology by diverse populations everywhere in the world represents a challenge. And it's also an important ethical marker. We are not supposed to include populations because of the lack of access to internet. For example, the lack of access to technology. This is something that becomes a costly enterprise because then the sponsors of the trials may need to provide that technology, that access to internet, while the participants are part of the clinical investigation. Another source of challenge is to bring your own device. For those who already have some of these devices, the use of those devices may represent sources of variability if it's not carefully looked at and controlled before deploying decentralized clinical trials. So these are some of the items that I could say represent the challenge in implementing decentralized clinical trials globally; they are surmountable if we think carefully and we plan carefully. These trials are not again, to retrofit traditional trials with a decentralized solution.   Janet Kennedy: (24:25) Well in thinking about the process of every country having their own regulatory process, their own design; are we at all in the same place with what the data means, or do we also have to worry about the interpretation of the data coming from a decentral trial?   Isaac Rodriguez-Chavez: (24:42) Decentralized clinical trials is all about mapping communications and mapping the data flow to have continuity on the data flow and to mitigate sources of variability. The data can be characterized and understood as coming from remote locations, coming from central locations. And we're in the process of learning right now, sources of variability, but that's one of the beauties of decentralized clinical trials - you can implement and design multiple solutions to mitigate the sources of variability of the data in these trials. And there has to be a customized statistical plan put in place to analyze the data in a meaningful way. We are yet to learn how the regulatory agencies will take all of this data and essentially what level of tolerance they may have, in regards to some level of variability that might exist in the CTs, as exist in any clinical investigation.   Janet Kennedy: (25:48) Now that you've left the FDA and you're working in the private sector, how in your role as the Head of the Global Center of Excellence for DCT Strategy, how does that impact your ability to get conversations going, and what is your role in that?   Isaac Rodriguez-Chavez: (26:05) My conversations are not impacted. I respect and maintain the confidentiality of the work that I did at the FDA. I essentially recuse when I need to recuse from specific conversations with specific entities or products. But other than that, I am not impacted in my daily work by leading the strategy of decentralized clinical trials at PRA Health Sciences. In fact, my level of activity is, I would say very high; I'm very engaged with multiple entities in the industry and in the clinical research field at large. And so one of the things that I do - I wear multiple hats - is to essentially assess the suitability of trials and opportunities to implement end to end solutions from the start to the very end, using decentralized clinical trials, assess technologies that can be put in place in decentralized clinical trials, partner with a great team that we have in PRA Health Sciences, including the team of operations, regulatory affairs, technology team, quality control, quality assurance, the legal team, the qualified vendors that we have to holistically assess the suitability of every opportunity that we engaged on to implement meaningful, customized high impact to end solutions on decentralized clinical trials.   Isaac Rodriguez-Chavez: (27:42) So that is a very dynamic work. I also engage on protocol design, protocol review, protocol assessment for decentralized clinical trials, and I engage on training and education - internally and externally. I am engaged on being a spokesperson for PRA Health Sciences regarding decentralized clinical trials for the industry at large. I also provide consultation services to assess the pipelines of multiple partners and pharmaceutical companies who would like to have a holistic view of their pipeline, and leverage one clinical trial with future possibilities, and to essentially participate as a leader in the field, sharing knowledge and information regarding decentralized clinical trials technologies, the modernization of clinical research in multiple areas, including the areas of infectious diseases, vaccines, immunology, virology, oncology.   Janet Kennedy: (28:50) Well, I have to admit, I am both proud and amazed at your workload and exhausted thinking about all the things that you do. I'm thrilled that you are over on the private side and working for a company that has an office in our area, in the Raleigh area, and I can't tell you how fascinated I am with our conversation so far. And I feel like there's a lot more that I'd love to ask you about, particularly in regards to CRAACO, the Clinical Research As A Care Option, and how patients have both factored into the changes that happen as a result of COVID and also going forward with how they're embracing decentralized clinical trials, but we're going to have to save that conversation for another day. You've been listening to People Always, Patients Sometimes, and my guests, Dr. Isaac Rodriguez-Chavez, who is the Senior Vice President of Scientific and Clinical Affairs, and also the Head of the Global Center of Excellence for DCT Strategy at PRA Health Sciences. Isaac, thank you so much for joining me here today.   Isaac Rodriguez-Chavez: (29:57) And thank you, Janet and listeners for the opportunity to share some thoughts with all of you in regards to the modernization of clinical trials, our services at PRA Health Sciences, on the use of digital health technologies technologies in general, and the unification of clinical research with the standard healthcare systems using the CRAACO principle that we applied to. I look forward to future conversations, and please connect with me in LinkedIn if you would like to continue the conversation. Thank you again for listen.

In this conversation between two decentralized clinical trial experts, John Reites, CEO of THREAD, and Andy Iverson, Clinical Outcomes Solutions lead at Medtronic, are discussing decentralized clinical trials: where they don't work yet and how that might change, the considerations for disease indication and trial type, what technology to use, and what an adoption journey could look like.   Key Takeaways: When DCTs don't work (yet) Technology, operations and knowledge perspectives What a phased approach looks like Identifying the key stakeholders     Speakers:  Andy Iverson is the Clinical Outcomes Solutions lead on the Evidence Optimization Center of Expertise team at Medtronic. In this role he functions as a subject matter expert and project team leader for initiatives related to artificial intelligence, decentralized clinical trials, and interoperability. His career includes 10+ years working with provider and payer systems and data. Andy serves as the Co-Chair of HL7s Biomedical Research and Regulation workgroup and is on the Operations Committee of the HL7 Vulcan FHIR Accelerator. He received a BA in Healthcare Management at Concordia College and an MS in Data Science at Northwestern. John Reites is CEO of THREAD. Executive intrapreneur turned digital health entrepreneur, his career includes 18 years leading global drug development, clinical trials, decentralized studies and clinical research innovation. As CEO of THREAD, he's led the company's efforts to change the way clinical research is conducted, focused on decentralized approaches and enabling the use of their platform to conduct modern research studies while supporting partnerships with their customers.    

The pandemic has helped fast track the adoption of technology in clinical research. This has been a much needed change and we’re headed in the right direction.  The change in turn has led to an increased focus on decentralized clinical trials (DCTs).  But what exactly is a DCT?  To learn more, I invited Derk Arts, Founder & CEO of Castor.  Derk has over fifteen years of experience in medicine, research and technology.  His company, Castor, provides useful technology for sponsors and sites to conduct decentralized clinical trials.  What is great about Derk is that he is a physician by training and now runs a clinical trial software company.  At a micro level, Derk understands the tools a doctor needs to provide optimal patient care in a clinical trial setting.  At a macro level, Derk can see what it takes to conduct a clinical trial with multiple sites/ patients and how technology can solve such complex problems.  This was a fun interview for many reasons.  Derk talks about the future of Electronic Data Capture (EDC), his thoughts on what it means to run a decentralized clinical trial, most misunderstood aspects of DCTs, Castor’s company culture, his favorite books, honey bees, and much more.  I hope you enjoy this conversation with the all amazing Derk Arts on the Clinical Trial Podcast. This podcast is brought to you by Florence Healthcare. To learn more, visit https://florencehc.com/.  

Hayden, Dan, Mike, and Devin talk about DCTs and why they are great and why they suck. They also dabble briefly on what would make the most sense for rules. Spirit of Time Attack is discussed in agonizing detail. Mike is an idiot and the team's New Year New Me Challenges. Places where you can reach us:Instagram: https://www.instagram.com/professionalawesomeracing/Facebook: https://www.facebook.com/professionalawesome777Website: https://professionalawesome.com

This is it! The biggest game of the year every year for me. WLOCP! The Must Win Game of every year. We cover keys to the win and news, plus we get a little hype from Lindsay Scott and DCTS checks in. Try Mybookie Promo code Dawgcast Try Manscaped Promo code DawgCast Check out the Boat House In Amelia

Critical automotive industry update, ‘Straya. October 2020. Year of the Weasel. Details next. In this report: Alfa Romeo updates Guilia for 2021 The plan to resurrect Wheels and Motor magazines New BT-50 pricing announced Hyundai i30 N DCT launch timing for Oz Jaguar interiors made from landfill 500,000 Nissan Leafs roll off the line Save thousands on any new car (Australia-only): https://autoexpert.com.au/contact AutoExpert discount roadside assistance package: https://247roadservices.com.au/autoexpert/ Did you like this report? You can help support the channel, securely via PayPal: https://www.paypal.com/cgi-bin/webscr?cmd=_s-xclick&hosted_button_id=DSL9A3MWEMNBW&source=url Mazda has announced pricing for the new BT-50. BT-50 is of course the somewhat effeminate clone of the new Isuzu D-MAX. Built in the same factory, etc. BT-50 kicks off at $42,090 for the XT dual-cab chassis base-model and extends to $59,990 for the GT, which is about $3000 less than the top-spec D-MAX. Hyundai - industriously taking geologic time to launch the 8-speed dual clutch version of a car for which I have enduring mad love: The Golf GTI-killing i30 N. Total weapon. The Fastback - so sexy. I30 N is seriously popular on this channel - 550,000 views across five videos, and counting. It’s one of the most popular performance car buying enquiries I get as well. And I can tell you the most popular impediment to buying one is - manual only. Typically the prospective owner has a partner, and said partner either can’t or won’t drive a manual - so, game over. The dual-clutch is the solution - due for local launch (finally) in the first half of 2021 here in Shitsville. Pro tip - have fun test driving this car, obviously, when you can. (Safely.) But don’t just test-drive it like you stole it. The DCT is gunna be awesome at that - it’s a done deal. DCTs are all excellent when you’re up them for the rent. Do as much test-driving as possible at low speeds - three-point turns, reverse-parking off a hill-start. Stuff like that. This is typically what DCTs are bad at. But if the new 8sp DCT in Sorento is anything to go by (and I don’t know how closely they are related, but probably quite a bit) you just might be pleasantly surprised. They’re also talking up the new lightweight seats - but I’d suggest that’s BS. They’re only 2.2 kilos lighter, and it’s a reduction in the sprung mass. So there’s that... The forged 19-inch alloys are probably more relevant - 14 kilos less in total, and all off the unsprung mass. Bigger brakes too. Not that it really needed that - they were already fairly death-proof. I did try to kill them, and I failed.

It pays to be prepared, especially in uncertain times. As sites struggle to maintain patient visits and keep trials moving forward amidst COVID-19, many are turning to remote monitoring and other elements of decentralized clinical trials (DCTs) to ensure their doors stay open. This SCRS Talks interview with Global Impact Partner (GIP) VirTrial provides insight into how sites can prepare to participate in DCTs or incorporate virtual visits into their trials. Listen in as VirTrial's Director of Business Development, Emil Hoeck, discusses industry trends related to COVID-19, identifies best practices for going virtual to support your site's sustainability, and addresses why now is the time to become virtual trial capable. 

Welcome to Creative Riding In this episode there is a Junkpile. There's also a chat about motorbikes. Specifically, Wiggins tells us how he transitioned from Sport Bikes to Harley-Davidsons. The new Honda Goldwing DOES NOT have reverse on the base model. All of the DCT versions DO have reverse. The 6-speed manual Goldwing Tour has electric reverse. All of the DCTs also have walk mode so you can move around parking lots on electric power. Junky was tired and dyslexic, but he kinda got it right. Wiggins was right about Ferrari. There is only one Ferrari. It's a world-recognized marque. They have their own city in Dubai. They are the Harley-Davidson of cars... well-known, brand-loyal, but not the best in the world, let alone their class. If you own a Ferrari and a Harley-Davidson, please contact us. Patrons, contact us on discord and tune in when we're recording the show. Cheers!!!! Thanks to our supporters on Patreon. Without them the show would not be possible. IF you want to become a patron, visit www.patreon.com/creativeriding please leave a rating or review in your podcast app. it will let others know that you're mildly amused and improve our visibility. To contact the show: creativeridingpodcast@gmail.com (740)563-2858 FB/IG: @creativeridingpodcast Twitter: @Creative_Rider Wiggins: @wiggzero9 @Field_Initiative_Knives Jae: @the_FlyingBanana

Its a lite episode...I couldn't get Old Dawg to the bunker...so it's just me in a place holder episode...but I got Isaiah's dad and DCTS to keep me company! Go Dawgs!! Beat the Cats!

Lots of great Facebook questions are coming in, including inquiries about driving in automatic or manual mode on DCTs; best rental cars and good driving roads in LA/Malibu. Jack G. in Chicago, IL nurtures his dream of a fun car, but family and parenting are entering his life. Then, Simon is helping his girlfriend Tiffany buy a sleek, stylish, fast car, and she likes the S5, but what else should she consider? Thanks for listening and watching, please Rate & Review our podcast, and write to us at everydaydrivertv@gmail.com

Digital Communications Technologies, or DCTs, like the Internet offer the infrastructure and means of forming a networked society. These technologies, now, are a mainstay of political campaigns on every level, from city, to state, to congressional, and, of course, presidential. In her new book, Presidential Campaigning in the Internet Age  (Oxford University Press, 2014), Jennifer Stromer-Galley, an associate professor in the iSchool at Syracuse University, discusses the impact of DCTs on presidential campaigning. In particular, Stromer-Galley takes a historical look at the past five presidential campaigns and the use of the Internet by incumbents and challengers to win the election. The promise of DCTs with respect to political campaigning was greater citizen participation in the democratic process. Stromer-Galley analyzes whether DCTs have lived up to this promise, or if the idea of the Internet promoting great political engagement is merely a myth. Learn more about your ad choices. Visit megaphone.fm/adchoices

Digital Communications Technologies, or DCTs, like the Internet offer the infrastructure and means of forming a networked society. These technologies, now, are a mainstay of political campaigns on every level, from city, to state, to congressional, and, of course, presidential. In her new book, Presidential Campaigning in the Internet Age  (Oxford University Press, 2014), Jennifer Stromer-Galley, an associate professor in the iSchool at Syracuse University, discusses the impact of DCTs on presidential campaigning. In particular, Stromer-Galley takes a historical look at the past five presidential campaigns and the use of the Internet by incumbents and challengers to win the election. The promise of DCTs with respect to political campaigning was greater citizen participation in the democratic process. Stromer-Galley analyzes whether DCTs have lived up to this promise, or if the idea of the Internet promoting great political engagement is merely a myth. Learn more about your ad choices. Visit megaphone.fm/adchoices

Digital Communications Technologies, or DCTs, like the Internet offer the infrastructure and means of forming a networked society. These technologies, now, are a mainstay of political campaigns on every level, from city, to state, to congressional, and, of course, presidential. In her new book, Presidential Campaigning in the Internet Age  (Oxford University Press, 2014), Jennifer Stromer-Galley, an associate professor in the iSchool at Syracuse University, discusses the impact of DCTs on presidential campaigning. In particular, Stromer-Galley takes a historical look at the past five presidential campaigns and the use of the Internet by incumbents and challengers to win the election. The promise of DCTs with respect to political campaigning was greater citizen participation in the democratic process. Stromer-Galley analyzes whether DCTs have lived up to this promise, or if the idea of the Internet promoting great political engagement is merely a myth. Learn more about your ad choices. Visit megaphone.fm/adchoices

Digital Communications Technologies, or DCTs, like the Internet offer the infrastructure and means of forming a networked society. These technologies, now, are a mainstay of political campaigns on every level, from city, to state, to congressional, and, of course, presidential. In her new book, Presidential Campaigning in the Internet Age  (Oxford University Press, 2014), Jennifer Stromer-Galley, an associate professor in the iSchool at Syracuse University, discusses the impact of DCTs on presidential campaigning. In particular, Stromer-Galley takes a historical look at the past five presidential campaigns and the use of the Internet by incumbents and challengers to win the election. The promise of DCTs with respect to political campaigning was greater citizen participation in the democratic process. Stromer-Galley analyzes whether DCTs have lived up to this promise, or if the idea of the Internet promoting great political engagement is merely a myth. Learn more about your ad choices. Visit megaphone.fm/adchoices

Digital Communications Technologies, or DCTs, like the Internet offer the infrastructure and means of forming a networked society. These technologies, now, are a mainstay of political campaigns on every level, from city, to state, to congressional, and, of course, presidential. In her new book, Presidential Campaigning in the Internet Age  (Oxford University Press, 2014), Jennifer Stromer-Galley, an associate professor in the iSchool at Syracuse University, discusses the impact of DCTs on presidential campaigning. In particular, Stromer-Galley takes a historical look at the past five presidential campaigns and the use of the Internet by incumbents and challengers to win the election. The promise of DCTs with respect to political campaigning was greater citizen participation in the democratic process. Stromer-Galley analyzes whether DCTs have lived up to this promise, or if the idea of the Internet promoting great political engagement is merely a myth.

Digital Communications Technologies, or DCTs, like the Internet offer the infrastructure and means of forming a networked society. These technologies, now, are a mainstay of political campaigns on every level, from city, to state, to congressional, and, of course, presidential. In her new book, Presidential Campaigning in the Internet Age  (Oxford University Press, 2014), Jennifer Stromer-Galley, an associate professor in the iSchool at Syracuse University, discusses the impact of DCTs on presidential campaigning. In particular, Stromer-Galley takes a historical look at the past five presidential campaigns and the use of the Internet by incumbents and challengers to win the election. The promise of DCTs with respect to political campaigning was greater citizen participation in the democratic process. Stromer-Galley analyzes whether DCTs have lived up to this promise, or if the idea of the Internet promoting great political engagement is merely a myth. Learn more about your ad choices. Visit megaphone.fm/adchoices