Podcasts about decentralized trials

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Best podcasts about decentralized trials

Latest podcast episodes about decentralized trials

Decentralized: The Decentralized Trials & Research Podcast
Navigating US Regulatory Change in an unpredictable environment

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Apr 28, 2025 59:25


2025-04-25 Hosts Craig Lipset and Jane Myles were joined by Greg Dombal and Laura DiAngelo (Agency IQ) to discuss the rapidly changing regulatory environment in the US, particularly in the clinical research sector, and its implications for those operating in this highly regulated space. The participants discussed the impact of recent changes such as reductions in force and reorganizations on the industry, and the evolving policies at the FDA, including the concept of an intermediate clinical endpoint and the interpretation and mapping of these concepts. The team also discussed the potential changes in the FDA's organizational structure, its impact on the agency's role in international collaborations, and the need for a balance between safety and efficacy in drug development.Resources:Subscribe to AgencyIQs FDA Today Newsletter hereMegyn Kelly Show with Dr. Martin Makary, new FDA CommissionerYou 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.

Decentralized: The Decentralized Trials & Research Podcast
Navigating the ICH E6 R3 with tools & solutions

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Apr 14, 2025 57:08


2025-04-11 Hosts Craig Lipset and Jane Myles were joined by our partners TransCelerate BioPharma Inc. and ACRO for a discussion on their tools & solutions that were developed to better understand the ICH E6 R3. We welcomed Christine Goffe (UCB), Paul Slagle (IQVIA), and Hasnaa Likaoui (BMS) to share about the data lifecycle framework tool and the trial design considerations tool that they have worked on to help better support trial planning and design.The tools can be found online at the following websites:Transcelerate ICH E6 Asset Library -- https://www.transceleratebiopharmainc.com/assets/ich-e6-asset-library/Transcelerate ICH E6 R3 Tools & Resources Webinar -- https://www.youtube.com/watch?v=W-6vM6hOLcU&feature=youtu.beACRO Interpreting ICH E6 R3 -- https://www.acrohealth.org/initiatives-hub/interpreting-ich-e6r3/You can join TGIF-DTRA Sessions 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.

Decentralized: The Decentralized Trials & Research Podcast
Bringing Community Oncologists into Trials

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Apr 7, 2025 53:25


2025-04-04 Hosts Craig Lipset and Jane Myles were joined by Kaitlin Morrison from UNC Lineberger Comprehensive Cancer Center. She shared her experiences with the potential of decentralized clinical trials, particularly in oncology, to expand participation beyond academic medical centers. We discussed the challenges of conducting clinical trials, the importance of trust and information sharing in building partnerships with local healthcare providers, and the potential benefits of working with these providers.Episode Resources:Conducting Clinical Trials With Decentralized ElementsIntegrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical PracticeYou can join TGIF-DTRA Sessions live on Friday's at 12:00 PM ET by checking out our LinkedIn. Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn to see what sessions are coming next and get the link to join. Learn more about Membership options and our work at www.dtra.org.

Decentralized: The Decentralized Trials & Research Podcast
Patient Experience Ratings & Decentralized Trials

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Mar 21, 2025 61:10


2022-03-18 Host Craig Lipset was joined by Irfan Khan (Circuit Clinical), Kelly McKee (Evinova), and Kerry Hicks (HW Investment Partners) for a conversation around the application of patient experience in clinical research, health ratings for providers, and more.You 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.

Decentralized: The Decentralized Trials & Research Podcast
A Patient Perspective on the DCT Field

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Mar 7, 2025 61:45


2022-03-11 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Stacy Hurt (Parexel) for an insightful discussion around the perspective of a patient on the DCT field.You 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.

Decentralized: The Decentralized Trials & Research Podcast
Breaking Barriers in Tech Adoption & AI

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Mar 3, 2025 59:44


2025-02-28 We welcomed Mike Wenger (FullStack Trials) and Melissa Holbrook (Clinical Research Advisory Group LLC) for a discussion around the biggest challenges in clinical trial technology adoption. We dived into getting feedback from sites, finding new ways to navigate using AI, and moreYou 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.

Decentralized: The Decentralized Trials & Research Podcast

2025-02-07 Hosts Craig Lipset & Jane Myles took the stage to share their thoughts around the SCOPE Summit that was held earlier this week in Orlando, FL. They covered high level findings and thoughts on the environment for 2025 and a download on a few panels they were moderated by the DTRA team.You 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.

Decentralized: The Decentralized Trials & Research Podcast
From Chaos to Clarity: Defining Who Does What?

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Feb 3, 2025 57:48


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.

Decentralized: The Decentralized Trials & Research Podcast
Demystifying eConsent - The European Forum GCP eConsent Suite of Tools

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Jan 30, 2025 57:53


2025-01-29 Hosts Craig Lipset and Jane Myles hosted a great discussion with Hilde Vanaken (EFGCP - European Forum for Good Clinical Practice) and Katrin Ong (Boehringer Ingelheim) to share about the suite of tools created by the European Forum for Good Clinical Practice's eConsent initiative and how they can be used to demystify eConsent.There are many resources available for use. Review the resources, tools, articles, and more here --> https://efgcp.eu/project?initiative=eConsentYou 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.

Decentralized: The Decentralized Trials & Research Podcast
What is needed for HCs to support routine care in clinical trials?

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Jan 20, 2025 55:47


2025-01-17 Irfan Khan, MD (Circuit Clinical) joined hosts Craig Lipset and Jane Myles for a discussion around what HCPs think about clinical research and how to gain their support on routine care in clinical trials. We discuss the journey of HCPs becoming investigators and what we need to drive this forward in the community.You 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 Scope of Things
Episode: 34 - Ringing in 2025 With Validating Novel Digital Clinical Measures, Decentralized Trials, and More

The Scope of Things

Play Episode Listen Later Jan 7, 2025 27:13


In this episode of the Scope of Things, host Deborah Borfitz delivers the news on an investigation into data reporting problems in major Ticagrelor clinical trial PLATO, the need for more sex-aware cancer research, Alzheimer's studies looking at brain shrinkage associated with immunotherapies (and repurposing drugs as potential new treatments), and a large, decentralized trial that successfully uncovered disease-causing genetic variants in hundreds of participants. Benjamin Vandendriessche, chief delivery officer of Digital Medicine Society, also joins in to talk about a newly completed project with the FDA that is providing guidance and resources on how to validate novel digital clinical measures.  News Roundup PLATO trial investigation Findings published in The BMJ “OncoSexome” project Paper in Nucleic Acids Research Brain shrinkage with Alzheimer's treatment Research in The Lancet Neurology  Repurposing drugs for Alzheimer's Study in Alzheimer's & Dementia  Mayo Clinic Tapestry study Article in Mayo Clinic Proceedings Guest  Benjamin Vandendriessche, chief delivery officer, Digital Medicine Society The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider's look at clinical research today.

Decentralized: The Decentralized Trials & Research Podcast

2024-12-20 Hosts Amir Kalali, Craig Lipset, and Jane Myles came together for the final TGIF-DTRA of the year, 2024 in Review! We shared more about what we did in 2024 at DTRA, what has been happening in the ecosystem, and some predictions for 2025!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.

Decentralized: The Decentralized Trials & Research Podcast
Investigating Data Quality in Hybrid Clinical Studies

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Dec 9, 2024 52:38


2024-12-06 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Anna Yang and Elizabeth Mandel (Genentech) joined us for a discussion around defining, measuring, and benchmarking data quality with 2 ongoing hybrid studies.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.

Decentralized: The Decentralized Trials & Research Podcast
Increasing Adoption of Wearables in Clinical Trials

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Nov 25, 2024 54:22


2024-11-22 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Keith Robinson, MD, MS, FCCP and Megan Parisi, MS, CCRP from Syneos Health and Nick Delmonico from Strados Labs for a discussion around wearables. We discussed challenges in increasing adoption of wearables, factors that are holding things back from greater widespread adoption, and the benefits/ROI of wearables and novel measurements.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.

Decentralized: The Decentralized Trials & Research Podcast
Unlocking the Potential of Clinical Trial Data: New CRDSA Standards

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Nov 4, 2024 57:34


2024-10-31 Clinical Research Data Sharing Alliance (CRDSA) published two new standards earlier this year: the Standard for Sharing Clinical Study Data and the Standard for Secondary Analysis of Clinical Study Data.We held a great discussion on how these standards aim to facilitate the responsible sharing and use of anonymized individual patient data from clinical studies to support the research community and accelerate the discovery and delivery of new therapies to patients. Data Reuse in Regulatory Submissions: The Role of Data Platforms resource was discussed during the live session as well.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.

Decentralized: The Decentralized Trials & Research Podcast
The Venn Diagram of Point of Care Trials, DCTs, and RWE

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Oct 15, 2024 53:20


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.

Decentralized: The Decentralized Trials & Research Podcast
How can Academic Health Centers inject innovation back into clinical trial conduct?

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Oct 14, 2024 57:41


2024-10-11 Hosts Craig Lipset, Jane Myles, and Dr. Amir Kalali were joined by Donna O'Brien and Rachel Sher (Manatt) and how their work is expanding access and enrollment and driving innovation for clinical trials in academic centers.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.

Decentralized: The Decentralized Trials & Research Podcast
Protocol Changes - Covid and Beyond

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Oct 7, 2024 60:12


2024-10-04 Hosts Jane Myles and special guest host Jean Sposaro (BMS) welcomed Joe Unger (Fred Hutch) for a conversation. The COVID-19 pandemic significantly decreased cancer clinical trial enrollment and swift changes were needed from researchers, regulators, and policymakers to ensure research and care could continue. He shares more about a task force created to better understand the impact of the pandemic on the conduct of oncology clinical trials.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.

Decentralized: The Decentralized Trials & Research Podcast
Conducting Clinical Trials with DCT Elements Guidance

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Sep 23, 2024 57:14


2024-09-20 Hosts Craig Lipset and Jane Myles hosted a discussion around the long-awaited FDA Final Guidance on DCTs: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties.A host of guests were brought to the stage to share perspectives on what they are excited for about this new guidance, what ambiguity was cleared up, and more!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.

Decentralized: The Decentralized Trials & Research Podcast

2024-09-13 Hosts Craig Lipset and special guest hosts, Ali Holland and Pamela Tenaerts (Medable) hosted a discussion around DCT Adoption in Covid and Beyond with Dr. Pablo Cure and Thomas Radman (NCATS).In 2023, NIH NCATS posted an RFI to understand the role of decentralized methods in trials and DTRA held a listening session and created a response to the RFI with the input of our membership community. This RFI lead to an NIH NCATS 2024 DCT Report released in June 2024. We held a conversation with Dr. Cure and Thomas around catalyzing the use of these innovative methods to drive access for more patients.Blog mentioned in episode --> https://ccos-cc.ctsa.io/news/mikes-blog/you-say-po-tay-toe-and-i-say-po-tah-toeYou 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.

Decentralized: The Decentralized Trials & Research Podcast
Recruitment & Retention through Innovation

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Sep 9, 2024 56:20


2024-09-06 Hosts Craig Lipset and Dr. Amir Kalali were joined for a conversation about the Trial Innovation Network's Recruitment Innovation Center and their focus on becoming an evidence-based center for recruitment and retention strategies to improve the quality of trials and increase enrollment & health outcomes across America. We'll be joined by Paul Harris, Terri Edwards, Leslie Boone, M.P.H., Mary Stroud, and Brooklyn Henderson (Vanderbilt University) for the discussion.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.

Decentralized: The Decentralized Trials & Research Podcast
Inspection Readiness for Decentralized Trials

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Aug 23, 2024 59:48


2022-12-22 Host Craig Lipset held a conversation around Inspection Readiness for Decentralized Trials. He was joined by special guests Sheila Gwizdak, Doug Shaw and John Sikora for the conversation around inspection readiness for decentralized trials and what to be thinking of, with a focus on patient safety and data integrity.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.

Decentralized: The Decentralized Trials & Research Podcast
Decentralized Clinical Trials in the Trial Innovation Network

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Jul 29, 2024 58:39


2024-07-26 Hosts Craig Lipset and Jane Myles were joined by Sarah Dunsmore (NIH/NCATS), Paul Harris (Vanderbilt University), and Daniel Hanley (Johns Hopkins University) for a discussion around the use of decentralized elements and methods in the Trial Innovation Network. Read more about the trials conducted that included decentralized elements in their paper here --> https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10465321/Learn more about the Trial Innovation Network on their website --> https://trialinnovationnetwork.org/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.

Decentralized: The Decentralized Trials & Research Podcast

2024-07-19 Hosts Jane Myles and Angela Radcliffe were joined by Alicia C. Staley from Medidata Solutions for a fabulous conversation about her whitepaper on Medidata's Patient Centricity by Design (PCbD) process and the work they are doing to accommodate the perspectives and preferences of patients and caregivers.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.

OffScrip with Matthew Zachary
[HIATUS] The One with Craig Lipset

OffScrip with Matthew Zachary

Play Episode Listen Later Jul 16, 2024 32:26


On the show today —> The venerable Craig Lipset, a storied luminary in the annals of clinical trial innovation — and I mean innovation with a Capital I. (None of that lower case crap happening here on my watch) Craig is the Founder of Clinical Innovation Partners and the Co-Founder of Decentralized Trials & Research Alliance (DTRA), and a proud expatriated Long Islander who pronounces Rutgers the proper way and has a penchant for Wegmans. He ticks every box. He's also been at the literal forefront of clinical trial research and development for over 30 years. Warning that the following episode may contain explicit acronyms and an overdose of syllables.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Decentralized: The Decentralized Trials & Research Podcast
Navigating eConsent Implementation Chaos

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Jul 15, 2024 57:55


2024-07-12 Hosts Craig Lipset and Jane Myles joined us for a discussion with Irina Grishina and Liz Quinlan (CSL Behring) about eConsent and challenges and successes with implementation.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.

Decentralized: The Decentralized Trials & Research Podcast
Building Clinical Trial and Health Research Access via Community Health Centers

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Jul 1, 2024 58:41


2024-06-28 Hosts Dr. Amir Kalali and Jane Myles were joined by Pete Fronte (Altura Health), Ruma Bhagat (Genentech) and Dr. Jim Schultz (Neighborhood Health) to discuss a white paper and toolkit released about Building Clinical Trial & Research Access via Community Health Centers. We look forward to hearing more about their work to engage underrepresented populations to diversify research enrollment.View the white paper/toolkit here --> https://alturastudies.com/research-ecosystems/#researchdiversitywhitepaperYou 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.

Decentralized: The Decentralized Trials & Research Podcast
FDA Inspection of a Decentralized Meta-Site

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Jun 24, 2024 56:29


2024-06-21 Hosts Craig Lipset, Dr. Amir Kalali, and Jane Myles were joined by Jonathan Cotliar (Science 37) for a discussion around their recent successful FDA Inspection of a decentralized meta-site, which is a huge milestone in virtual site quality assurance and compliance.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.

Decentralized: The Decentralized Trials & Research Podcast
Data Diversity, Data Access, and Rights

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Jun 17, 2024 61:30


2024-06-14 Hosts Dr. Amir Kalali and Jane Myles were joined by Anthony Costello (Medidata) for a conversation around data diversity, data access, and rights, and his experience at Medidata, as well as industry wide.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.

Decentralized: The Decentralized Trials & Research Podcast
Data on the Adoption of Decentralized Methods in Cancer Trials During the Pandemic

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Jun 12, 2024 57:51


2024-06-11 Hosts Craig Lipset, Dr. Amir Kalali, and Jane Myles were joined by Dr. Timil Patel, a Medical Oncologist with the FDA for a discussion around the recently released ASCO abstract around adoption of decentralized trial elements in cancer clinical trials during the pandemic.Clinical Trials Transformation Initiative (CTTI) and FDA (with support from Decentralized Trials & Research Alliance (DTRA) collected data from research sponsors to understand the methods that were adopted, the associated challenges to address, and the direction ahead. Read the ASCO abstract here --> https://meetings.asco.org/abstracts-presentations/237149You 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.

Decentralized: The Decentralized Trials & Research Podcast
Sponsor Experience Implementing DCTs

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Jun 10, 2024 57:54


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.

Decentralized: The Decentralized Trials & Research Podcast
TGIF-DTRA Ask Us Anything DCT Edition

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Jun 5, 2024 50:10


2024-05-31 Hosts Amir Kalali and Jane Myles joined allowed guests to join as ask their burning questions about all things DCT. A discussion about the EX-US Market in Japan, adoption of DCT methods, and more were addressed during the live session.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.

Decentralized: The Decentralized Trials & Research Podcast

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.

Decentralized: The Decentralized Trials & Research Podcast
Let's Celebrate Clinical Trials Day!

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later May 20, 2024 57:50


2024-05-17 Hosts Amir Kalali, MD, Craig Lipset, and Jane Myles were joined by industry champions Terttu Haring (Syneos Health), Kelly McKee (Evinova), and Beth Brooks (Sanofi) to discuss raising awareness of clinical trials, why clinical trials day matters, and how they embody this in their day-to-day work.We are excited to celebrate Clinical Trials Day on Monday, May 20.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.

Decentralized: The Decentralized Trials & Research Podcast
Driving Oncology Trials to the Community

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later May 13, 2024 53:46


2024-05-10 Hosts Amir Kalali and Jane Myles were joined by Dr. David Waterhouse (Oncology & Hematology Care) to discuss transforming clinical trials to enable cancer patients to participate closer to home.The paper discussed during the session is available here.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership and our work at www.dtra.org.

Decentralized: The Decentralized Trials & Research Podcast
Building Diversity & Inclusion into Clinical Trials

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later May 6, 2024 66:09


2024-04-26 Our hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Otis Johnson (Trial Equity) and Jeffrey Zucker (Tekton Research) to share about how to expand clinical research opportunities to diverse populations. Trial Equity has a training curriculum to help companies achieve this goal of expanding access to patients that we explored during the conversation.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership and our work at www.dtra.org.

Decentralized: The Decentralized Trials & Research Podcast
Unlocking Digital Health Tech in Clinical Trials

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later May 6, 2024 53:42


2024-05-03 Hosts Amir Kalali, Craig Lipset, and Jane Myles were joined by Moe Alsumidaie (The Clinical Trial Vanguard) for a robust discussion around digital health technologies and how they can be best utilizing in advancing clinical trials.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and X. Learn more about Membership and our work at www.dtra.org.

Decentralized: The Decentralized Trials & Research Podcast
Site Needs for Decentralized Trials

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Apr 22, 2024 61:25


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.

Decentralized: The Decentralized Trials & Research Podcast
Novel Platform & DCTs Drive Innovation

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Apr 15, 2024 59:00


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.

Decentralized: The Decentralized Trials & Research Podcast
What Evidence do you need for DCTs and how to find it?

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Apr 8, 2024 57:50


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.

Decentralized: The Decentralized Trials & Research Podcast
Is there evidence for what eConsent features patients prefer?

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Mar 25, 2024 55:11


2024-03-22 Hosts Craig Lipset and Jane Myles dove into a conversation with Andrew Mackinnon (Medable) about their work with Duke on patient preference in an eConsent study. Learn more about the Pilot Study here --> https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-023-01432-wFollow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Decentralized: The Decentralized Trials & Research Podcast
Growing Enthusiasm for DCTs in Pakistan

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Mar 18, 2024 65:32


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.

Decentralized: The Decentralized Trials & Research Podcast
Lab Specimen Logistics in Decentralized Trials

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Mar 8, 2024 62:19


2022-04-29 Hosts Amir Kalali and Craig Lipset were joined by Shawn Tedman (ixlayer) and Beth Culver (MRN) to discuss lab specimens and the logistics of obtaining them from patients when the trials are being run from home.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Decentralized: The Decentralized Trials & Research Podcast

2024-03-01 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by Dr. Rohit Aggarwal to share his experience and expertise regarding the MINT study and the work he has accomplished thus far in the rare disease space.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Decentralized: The Decentralized Trials & Research Podcast
Techquity - Digital as a Bridge, Not a Divide

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Feb 19, 2024 58:05


2024-02-16 Hosts Craig Lipset and Jane Myles were joined by Vik Kheterpal (CareEvolution), Dr. Apruv Soni (Univers of Mass.), and Dr. Ed Ramos to discuss findings and data from digital studies/interventions that can really address inequities in healthcare and reaching underserved populations.A great conversation was had about expanding the dialogue around the digital ecosystem for healthcare innovation.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Decentralized: The Decentralized Trials & Research Podcast

2024-02-09 Hosts Craig Lipset and Jane Myles were joined by Stephen Sundquist (3CTN) and Bianka Courcelle (HSJ) to discuss the PI site perspective and experiences in implementing a trial cluster involving a satellite site in supporting patient access. The specific clinical trial case illustrates how the CRAFT hybrid DCT approach was applied to support collaboration between the pediatric cancer centre and an adult centre in supporting an AYA patient on trial.A great conversation was had about how the CRAFT hybrid DCT Framework; why it was built, how it was constructed, and why it matters.Site Supervision Template: https://3ctn.ca/wp-content/uploads/2022/04/CRAFT-Site-Supervision-Plan_WM.pdfCRAFT Framework: https://3ctn.ca/for-researchers/craft/Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Decentralized: The Decentralized Trials & Research Podcast

2024-02-02 Hosts Craig Lipset and Jane Myles were joined by Chunky Satija (Everest Group) for a discussion around mergers & acquisitions in the DCT space and what we may see on the horizon as the market evolves throughout the year.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Decentralized: The Decentralized Trials & Research Podcast
Importance of Chief Patient Officer in Life Sciences Orgs

Decentralized: The Decentralized Trials & Research Podcast

Play Episode Listen Later Jan 29, 2024 57:27


2024-01-26 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by the fabulous Stacy Hurt (Parexel) to discuss the importance of the Chief Patient Officer (CPO) role in the life sciences industry. A great conversation was had about how the CPO is uniquely positioned to improve patient access and experience. A link to the CTTI paper on ROI & engagement that was discussed during the session is linked here.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Decentralized: The Decentralized Trials & Research Podcast

2024-01-19 Hosts Craig Lipset and Jane Myles were joined by Derk Arts (Castor) for a riveting conversation about the future of AI in clinical trials and how we can utilize this technology to make trials more efficient.Learn more about DTRA Circles, especially the AI Circle kicking off in January 2024.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

WCG Clinical Services Fireside Chats
Diversity & Inclusion with Technology in Decentralized Trials

WCG Clinical Services Fireside Chats

Play Episode Listen Later Nov 22, 2023 65:05


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