The Scope of Things

In this episode of the Scope of Things, host Deborah Borfitz brings you the news on a precision medicine initiative in Sweden integrating research with healthcare, newly available cardiometabolic clinical data registries for real world evidence projects, updates to guidelines on the reporting of clinical trials, AI improving the monitoring of movement disorders, and the best-yet biomarker for stroke and dementia risk. Joining the conversation is Briony Swire-Thompson, director of the Psychology of Misinformation Lab at Northeastern University Network Science Institute, to discuss the current misinformation epidemic and how clinical trials and sites can best deal with it. News Roundup   Precision Omics Initiative Sweden (PROMISE) Correspondence in Nature Medicine  Article in Clinical Research News  Cardiometabolic clinical data registries Article in Clinical Research News New CONSORT reporting guidelines  Article in JAMA VisionMD for analyzing motor function Article in Nature Best-yet biomarker for stroke and dementia risk Article in Diagnostics World News  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.

In this episode of The Scope of Things, host Deborah Borfitz covers the latest news, including setting expectations for Phase II cancer trials, key learnings about dementia from the Nun Study, links between cardiovascular disease and mild cognitive impairment, using aspirin to prevent cancer spread, a clinical trial map to improve study access, and a naturally occurring molecule that rivals Ozempic in its weight loss potential. Deborah also speaks with Ravi Parikh, medical director of data and technology applications shared resource at Winship Cancer Institute of Emory University, about a novel AI platform he helped develop to translate clinical trial results to real world populations. News Roundup Phase 2 cancer drug trials Study in the Journal of the National Cancer Institute   Nun Study insights Review article in Alzheimer's & Dementia  DORIAN GRAY project Press release by the European Society of Cardiology Aspirin for preventing cancer spread Study in Nature  New clinical trial map  News announcement on the EMA website Molecule rivaling Ozempic Study in NatureThe 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.

In this episode of the Scope of Things, host Deborah Borfitz delivers the latest on an AI-powered trial screening tool that outperforms research staff, a strategy report on ways to boost cancer vaccine work, the continued absence of pregnant women in clinical trials, a program bringing studies directly to people in rural Utah, and efforts to integrate clinical trials into routine patient care in medically underserved areas of Oklahoma. Wes Michael, founder and president of Rare Patient Voice, also joins in to discuss how his company is connecting people undertaking research studies with participants eager to share their insights—and getting paid to do so. News Roundup  AI clinical trial screening tool Research letter in JAMA  Strategy report on cancer vaccines Commentary in Cambridge Prisms: Precision Medicine  Exclusion of pregnant women from trials Article in American Journal of Obstetrics and Gynecology Bringing cancer care and trials to Utah's rural residents Press release on Huntsman Cancer Institute website Integrating clinical research into primary care News on OU Health Sciences website Guest Wes Michael, president and founder of Rare Patient Voice 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.

In this episode of the Scope of Things, host Deborah Borfitz provides the latest on new criteria for defining and diagnosing obesity, the case for including pregnant women in vaccine trials, the subtyping of osteosarcoma, an inert gas being tested as an Alzheimer's treatment, and more. Joining the conversation is David Sall, president and CEO of Patient Enrollment Advisors, who talks about the origins of the Participant Engagement Award at SCOPE 2025 and how the conversation around participant engagement has changed over time (and the changes that still need to happen). Finally, we have Allison Proffitt, editorial director of Clinical Research News, interviewing Trân Lê and Sohit Gatiganti, co-founders of Grove AI and the winners of the Participant Engagement Award at SCOPE 2025. 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.

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.

In this episode of the Scope of Things, host Deborah Borfitz covers concerns surrounding the study and treatment of obesity, a new “opening doors” initiative to clinical trials, debate over the European Union AI Act, the first international-level clinical study using secure multiparty computation, a hopeful treatment for kids with lethal brain tumors, and a ChatGPT tool created by the NIH to match potential volunteers to relevant studies. Joining the conversation is Orr Inbar, CEO and co-founder of QuantHealth, who discusses how his company is using AI to simulate clinical trials to alleviate costs and efficiency issues for the notoriously complicated drug development process. He also shares the proprietary tech powering QuantHealth's AI and where he sees AI heading as 2025 unfolds.  News Roundup Perspectives on the EU AI Act Insights about the rollout in Clinical Research News Article in Clinical Research News about discussion at SCOPE Europe Secure multiparty computation Article in Bio-IT World Study in npj Digital Medicine Cell therapy for childhood brain cancer Study published in Nature  Stanford Medicine press release  TrialGPT tool Study in Nature Communications  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.

In this episode of the Scope of Things, host Deborah Borfitz shares the latest news on a drug repurposing AI model now being tested in rare disease clinical trials, a new way forward for triple-negative breast cancer, Jill Pellegrino's transition from CVS to AutoCruitment, incorporating placental pathology into perspective clinical trials, making ethical oversight of clinical trials more “fit-for-purpose,” and publication bias with industry sponsored studies for psychiatric drugs. We also have Allison Proffitt, editorial director of Clinical Research News, interviewing speakers at SCOPE Europe 2024 on how AI is being used for clinical trials, their pick for the 2024 rising star in the clinical research ecosystem, and the most hotly-debated topics in trial planning and execution. SHOW NOTES News Roundup AI for drug repurposing Study in Nature Medicine Window trial for new breast cancer approach Study in Science Advances Article in Bio-IT World  Prescreening regimen of AutoCruitment Article in Clinical Research News Episode 12 guest appearance on podcast  Trials needing placental pathology Opinion piece in Trends in Molecular Medicine Fit-for-purpose ethical oversight Special communication in JAMA  “Sponsorship effect” on psychiatric drug trials Study in Journal of Political Economy   Guests  Nicole Stansbury, Head of Global Clinical Operations at Premier Research Farrell Healion, Head of Emerging Technologies at AstraZeneca Jonathan Crowther, Head of Predictive Analytics, PRD (OARS), Pfizer  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.

Tune in for the latest news and trends in this month's episode of the Scope of Things, where host Deborah Borfitz covers everything you need to know about a pending launch of a large treatment trial for Graves' disease, a recruitment campaign for a diagnostic tampon, Walgreens and BARDA's new partnership, how eligibility criteria has been excluding people of African or Middle Eastern descent from cancer studies, and more. Joining the discussion is Aaron Mackey, vice president of AI and data science at Lokavant, who talks about the unintended consequences of decisions made during trial planning that can lead to questionable conclusions, how AI and ML are helping with the diversity issue in trial participation, and his stop gap emergency plan to keep trials on track if there is no digital support available. SHOW NOTES News Roundup Phase 3 trial for Graves' disease Article in Clinical Research News  Quality of life measures in cancer studies Study in Journal of Clinical Oncology Article in Clinical Research News Rapid recruitment for a diagnostic tampon trial Article in Clinical Research News Reference trial emulation Study in PLOS Medicine  Walgreens/BARDA partnership News brief in Clinical Research News “Detective” algorithm for improving trial design Study in Nature Genetics Exclusion of people with Duffy-null phenotype Study in JAMA Network Open    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.

This month's episode of The Scope of Things features the latest trending news from host Deborah Borfitz, including a planned library of “nature's drugs” targeting complex diseases, a paradoxical approach to treating cancer, how government policies can help improve equitable access to cancer trials, and the possibilities of reversing multiple sclerosis nerve damage. Marshall Summar, CEO of Uncommon Cures, and Tamanna Roshan Lal, Chief Medical Officer of Uncommon Cures, join the conversation to discuss how their organization is tackling the root causes of rare diseases trials that take too long and cost too much. They delve into the market interest behind rare disease trials and what Uncommon Cures is doing differently, as well as share the company's international expansion plans and where they see this operationalized rare disease clinical trial paradigm in a few years. 

Tune into this month's episode of the Scope of Things, where host Deborah Borfitz covers the use of AI for trial screening and recruitment purposes, a diabetes drug that may help treat sleep apnea, questionable advice from the FDA given to departing staffers, why the entire clinical trial enterprise may need to be revamped to eliminate systemic biases, and more. Hannah Kemp, vice president of strategic client engagement at Surgo Health, also joins the conversation to talk about how Surgo Health is helping companies recruit participants and her SCOPE 2024 presentation, as well as her thoughts on patient-focused drug design and the challenge of getting study sponsors on-board with enrollment strategies. 

In this month's episode of the Scope of Things, host Deborah Borfitz gives you the latest news on the fallacy of a survival benefit for cancer patients participating in clinical trials, how and why federally qualified health centers are getting involved in studies, efforts to disrupt the current practice of excluding pregnant and lactating women from participation, great news about the impact of precision medicine on the outcomes of kids suffering from aggressive cancers, and more. Jonathan Kimmelman, PhD, Professor of Biomedical Ethics at McGill University, also joins Deborah to discuss current dilemmas in clinical development and how research standards are trending. Kimmelman talks about the ethical implications when trial sponsors don't fully disclose how patient input is utilized in drug development, key policies that are necessary and would have a big impact on regulators, and what would-be participants can do to be more informed about trials. 

In this episode of the Scope of Things, host Deborah Borfitz covers the latest news on an AI model for comparing drug effectiveness, adoption of minimal residual disease as an endpoint for multiple myeloma, using HIV treatments for Alzheimer's disease, lack of diversity in Alzheimer's trials, and more. Yvonne Rodriguez, founder and CEO of Egality Sciences, also joins the conversation to talk about breaking down the barriers to clinical research participation in underserved communities. She also delves into her personal story of what inspired her to start her company, how Egality Sciences is teaching physicians and staff at local hospitals to get and stay involved with industry-sponsored studies, and the challenges that need to be overcome to ensure that every patient has equal access to clinical trials as a treatment option.  

In this episode of the Scope of Things, host Deborah Borfitz brings you the monthly breakdown on current events, such as tailoring medications to individual patients using digital twins, the use of a skin biopsy test to diagnose neurodegenerative diseases, and the launch of a European-wide platform promoting access to care for all. She also speaks with Michael Snyder, chair of the department of genetics at Stanford University School of Medicine and director of the Center of Genomics and Personalized Medicine at Stanford, about the growing adoption of wearables and home microsampling—and how this will dramatically change clinical trials and care. Snyder also delves into the “Amazon-ing” of healthcare and how he envisions the creation and future of personalized metrics and customized interventions and how they can improve trial outcomes.  

In this month's episode of the Scope of Things, host Deborah Borfitz covers the latest news and emerging trends, including the launch of a company using single-solution software to connect a global network of clinical trial sites to study sponsors, a pharmacy-first program in the UK, a centralized staffing initiative at the National Cancer Institute, progress in getting patient-derived organoids into clinical trials to evaluate drug response, and more. She also speaks with Lifelines Neuro's chief scientific officer Dona Murphey, M.D., Ph.D. about shortcomings in the way EEGs are being use in clinical trials to monitor participants with potential brain damage, how EEG monitoring should be used in clinical research, and what the FDA has to say about all of this. 

In this month's episode of the Scope of Things, host Deborah Borfitz catches listeners up with the latest news of the clinical trials and research industry, starting with SCOPE 2024, where a record-breaking 4,000 attendees arrived to learn and discuss about new products, technology, and ideas. Other hot topics in this episode include convergence of clinical research and clinical care, patient centricity, protocol complexity, the growing use of AI, and an update on decentralized clinical trials. She also interviews CliniSpan Health founder and CEO Dezbee McDaniel, winner of the pitch contest at SCOPE, about his company's novel social media influencer relationship management platform for improving clinical research diversity. LINKS Summit for Clinical Ops Executives (SCOPE) Conference website Convergence of clinical research and clinical care Story in Clinical Research News [link to come, story runs 2/27?] Oliver Patch Project Website   Conference themes Savvy Cooperative's #AskPatients website Barnett International's GCP reference guide ProofPilot integrates Magnol.AI Press release  TransCelerate's Participant Data Return initiative Resource pack Impact of protocol design on trial performance Study in Therapeutic Innovation & Regulatory Science Use of AI in clinical development FDA-issued discussion paper 

In this episode of The Scope of Things, host Deborah Borfitz provides a rundown of the latest news in the clinical trials field: a massive health research initiative in the UK, widespread overdosing of trial participants, a cholesterol-lowering vaccine, the growing popularity of phage therapy, a novel scoring mechanism for de-risking trials for chronic diseases, a strategy for making staph vaccines a reality, and the latest oral drugs heading to trials that could eliminate one of the chief barriers to insulin therapy for diabetics. Deborah also speaks with Donna Dorozinsky, President & CEO of Just in Time GCP, about recent changes related to expectations of institutional review boards, the use of social media for recruitment and communication purposes, and the impact of world events on clinical data management.  

New Year, new podcast format! In 2024's first episode of the Scope of Things, host Deborah Borfitz gives you the latest news from the clinical trials industry, including AI's role in the creation of digital twins, the obesity epidemic and the drugs intended to combat it, improving diversity in trial candidates, and more. We also have expert advice from Ward Lemaire, VP Head of Data Management and Central Monitoring at J&J Innovative Medicine, and Dan Hydes, Co-Founder and CEO at IgniteData, on SCOPE's new Startup Pitch Competiton, and how start-up companies can meet multiple demands and needs, direct their limited resources, and keep the innovation train going. New Advisory Board Ken Getz podcast episode  Ramita Tandon podcast episode   News Roundup AI and Chatbots Belong.Life Microsoft's Trial Matcher UF and NVIDIA's GatorTronGPT Genentech's smart digital assistants Digital Twins Pan-European project simulating stroke treatments Obesity Clinical Trials JAMA paper on unintended consequences of weight-loss drugs   FDA's Ozempic label change Physicians in Europe preferentially recommend lifestyle changes  New areas of interest Trial begins for Insilico Medicine's latest AI-discovered drug Brain metastases studies in Italy and Spain  Drug repurposing study in Australia for type 1 diabetes Anti-aging TAME trial of Metformin to start Pharmacy Research Organization RxE2 Platform for independent community pharmacists launches Gerald Finken podcast episode Amplifying the patient voice FDA's patient- focuse

 Can clinical trials be a helpful treatment option for patients? In this episode of The Scope of Things, host Deborah Borfitz speaks with Colleen Purcell Tenan, MD, Medical Director at Javara, about providing clinical research as a care option for patients. Tenan talks about the benefits of receiving clinical research care from one's own physician, Javara's process of matching patients with the right healthcare system for clinical trials, and how Javara supports providers who haven't done sponsor research before. She also shares her thoughts on where decentralized trial components best fit in clinical studies in a post-pandemic world and using remote technologies for convenient medical care and research. Scope of Things Links:  Clinical Research News Scope Summit Javara Links: Javara 

There are concerns surrounding the uses of AI in clinical trials, particularly on the regulations side. In this episode of the Scope of Things, host Deborah Borfitz discusses with Michael Ibara, Pharm.D., Chief Data Officer at Elligo, about the roadblocks and challenges obstructing AI's potential in clinical trials. Ibara also talks about his perspective on the necessary changes to the clinical trial process to further apply AI, why innovation is a key factor, and what can be done in terms of regulations both domestically and internationally. He also shares his experiences with building a better system of organizing and processing EHR data with the Astra Project. 

Selecting a vendor to do business with can be a tricky, convoluted process. How do you know who is the right fit? In this episode of the Scope of Things podcast, host Deborah Borfitz speaks with Dennis Salotti, Executive Director & Head, Clinical Outsourcing & Innovation at Jazz Pharmaceuticals, who shares what he knows about the complex vendor qualification process and the various ways sponsors and CROs are going about the expensive and time-consuming exercise. With two decades of experience in the field and having co-authored a report with Tuft's Center for the Study of Drug Development, Salotti provides valuable insight on what to prioritize during vendor assessment, what factors can affect customized assessments, and the importance of building—and sometimes rebuilding—relationships with vendors. He also delves into how effective internal data and precompetitive info sharing on routinely assessed areas can help reduce cycle time and how companies can act on this. Links from this episode:  Scope of Things Links:  Clinical Research News Scope Summit Jazz Pharmaceuticals: Jazz Pharmaceuticals   

What can be done to improve clinical trials for patients with chronic wounds? In this new episode of the Scope of Things, host Deborah Borfitz speaks with Dr. Caroline Fife, world-renowned wound care physician and Chief Medical Officer at Intellicure, about the clinical realities of chronic wounds and wound treatment. Dr. Fife shares her thoughts on the “sorry state” of clinical trials for wound care products and what she has learned as the Executive Director of the U.S. Wound Registry that shed some light on the matter. She also discusses how her first clinical trial sparked her drive to improve conditions and the barriers that prevent innovation in the development of new products and technology. Links from this episode:  Clinical Research News Scope Summit Intellicure   

What role do retail pharmacies have in research studies? In this episode of the Scope of Things, host Deborah Borfitz speaks with Ramita Tandon, Chief Clinical Trials Officer at Walgreens. Tandon discusses how retail pharmacies can play an important role in increasing access and retention in sponsor-lead drug development research. She also shares the specific approaches Walgreens is adopting in the US that have been gaining traction. Finally, she talks about why it is important to begin diversity and inclusion planning early in the drug development process and how it can allow researchers to think more holistically through the phases of clinical trials.    Scope of Things Links:  Clinical Research News Scope Summit   Walgreens Links: Walgreens 

In this episode of The Scope of Things, Deb Borfitz speaks with Murray Aitken, Executive Director of the IQVIA Institute, about diversity in clinical development, DEI methods that are and are not working, and the impact diversity has on clinical trials. Aitken also discusses FDA-issued policies to advance diversity and efforts to reduce disparities between subpopulations. He also talks about factors that contribute to those disparities, such as socio-economic backgrounds, genetics, and trust in the system. Finally, he delves into the importance of having diverse groups of participants—particularly Black and Hispanic Americans—in clinical trials to ensure that patients receive the best treatment options and healthcare access. Links from this episode:  Clinical Research News Scope Summit IQVIA Institute 

Years after serving in the Vietnam War, Virginia Byers Kraus's father had his hip replaced—three different times. Each time, she said, outcomes were worse. Joint replacement is often the result of osteoarthritis, a degenerative joint disease commonly known as “wear and tear” arthritis. There are no disease-modifying drugs for osteoarthritis and early diagnosis is difficult. But even though the CDC estimates that nearly one in four people in the United States has osteoarthritis, Kraus rejects that idea that the disease—and resulting pain and surgical treatment—is inevitable. Her group at Duke is developing a proteomic panel of biomarkers that will be able to identify people with active disease before the evidence is visible on an MRI or X-ray.  Scope of Things Links:  Clinical Research News Scope Summit Europe 

When Seqster was first founded in 2016, co-founder Ardy Arianpour had a lot of experience in next-gen sequencing and a vision for how consumers could control their health information. Arianpour envisioned a place where anyone can bring all their health data together in one place and share it on their terms. Since then, Arianpour says he has found many parts of the business challenging. There have been shifts in the business model over time, which began as direct-to-consumer. He credits Seqster's 2020 agreement with Takeda Pharmaceuticals as a tipping point. Now, with several pharma partnerships to boast, Seqster is more than a company, Arianpour insists to host, Deborah Borfitz, in the latest Scope of Things podcast. “This is a movement.” Links from this episode:  Seqster's Perfect Timing, Powerful Platform Might Change Health Clinical Research News Seqster 

Dr. Su Golder, associate professor and senior research fellow in the Department of Health Sciences at the University of York, has dedicated a significant portion of her career to improving the reporting of adverse events in clinical research. In this episode, she speaks with host Deborah Borfitz about why adverse events are vital to address but often difficult to ascertain for any given therapeutic intervention.  Golder talks about the strategic ways data can be manipulated—often leading to underreporting or misleading reporting—and the preferred guidelines that help researchers relay accurate information to clinicians and patients. She also discusses why data from randomized controlled trials are not always the best indicator of adverse advents in the real world and why social media provides valuable insights into why patients discontinue drug usage even when symptoms are considered minor. She says, “If something stops a patient from taking [a drug], then it doesn't matter how effective [that drug] is. So [patient experience] is the most important thing.”  Links from this episode:  Clinical Research News University of York Adverse Event Reporting May Need A Total Redo Medicines & Healthcare products Regulatory Agency Yellow Card reporting Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) PRISMA harms checklist: improving harms reporting in systematic reviews Consolidated Standards of Reporting Trials (CONSORT) OpenTrials: towards a collaborative open database of all available information on all clinical trials Cochrane Adverse Effects Methods Group   

In 2020, retail pharmacy giant CVS launched CVS Health Clinical Trial Services in response to the COVID-19 pandemic. They aimed to increase patient recruitment and encourage equitable participation in clinical research to accelerate COVID trials. In this episode, Jill Pellegrino, vice president of recruitment and RWE at CVS Health Clinical Trial Services, speaks with host Deborah Borfitz about CVS' service offerings and its collaborative work to improve the efficiency and applicability of clinical trials beyond vaccines. Pellegrino discusses how the company secured nearly 33,000 clinical trial participants in just two years and their work with pharmaceutical companies to understand patient behaviors and drive positive behavioral change through real-world evidence. She also talks about their cohesive data set of “100 million lives” and how the business works seamlessly with CVS' MinuteClinics to execute pragmatic trials. Finally, she discusses the company's goal to expand into multiple therapeutic areas—including oncology trials—and partner with Aetna to access a new potential patient base. Links from this episode:  Clinical Research News CVS Health CVS Health Clinical Trial Services CVS MinuteClinic 

Healthcare professionals are searching for new ways to fight bacterial infections as growing concerns around antibiotic resistance reach new heights. Though bacteriophages or phages—viruses that infect only bacteria—have long since captured scientists' attention, they are quickly gaining popularity as a new and promising therapeutic tool. In this episode, Graham Hatfull, professor of biological sciences at the University of Pittsburgh, speaks with host Deborah Borfitz about his team's research and diligent work to showcase phages as versatile therapeutic agents. Hatfull also talks about the impressive findings produced by experimental phage therapy clinical trials and the barriers that currently prevent phages from ubiquitous antibacterial clinical use. He discusses his team's efforts to sequence phages and build a therapeutic library, the role of phage therapy in combating tuberculosis and cystic fibrosis, and the novel benefits phages bring to transplant recipients. Hatfull also addresses the FDA's support of phage therapy through expanded access for compassionate use and the global push to enter phages into their first-ever randomized controlled trial.  Links from this episode:  Clinical Research NewzUniversity of Pittsburgh Phage Therapy of Mycobacterium Infections: Compassionate Use of Phages in 20 Patients With Drug-Resistant Mycobacterial Disease SEA-PHAGES (Science Education Alliance-Phage Hunters Advancing Genomics and Evolutionary Science) FDA Expanded Access for Compassionate Use Phage Australia 

A self-described “data hippie,” Christopher Boone, vice president and global head of health economics and outcomes research at AbbVie, knows a great deal about using real-world data and generating real-world evidence in clinical trials. Boone sits with host Deborah Borfitz to talk about the disruptive presence of real-world evidence within the clinical trial enterprise and how it encourages researchers to reimagine trial design from start to finish. He says, “Much of the data we care about is captured outside the walls of the provider environment… Now, with all the digital technology, you can really understand the [patient's] environment and experience in real-time.” Boone assesses how effective the industry has been in democratizing data, how the 21st Century Cures Act was “probably the single biggest catalyst” in the expansion of real-world data, the industry's transition to patient-centered research, and the systemic and cultural barriers challenging clinical studies today. He also shares tidbits from his upcoming talk at SCOPE Summit 2023 in early February. Links from this episode: Clinical Research News AbbVie 21st Century Cures Act Patient-Centered Outcomes Research Institute (PCORI) PCORnet SCOPE Summit  

Dr. Loaiza-Bonilla details the importance of equity in increasing access to medical care, the reignition of the National Cancer Institute's Cancer Moonshot program, and the U.S. Food and Drug Administration's intention to standardize eligibility criteria. He also talks about the Massive Bio platform that could, one day, deliver medication via drones or offer at-home phlebotomy services to assist cancer patients from start to finish. He says, “My dream is that if a patient is unfortunately diagnosed with cancer, they can say, ‘Hey Siri or Cortana, help me find a clinical trial,' and then the system does an e-consent, gets the records… screens them, and in 17 seconds you have the options. Then, [we get] them to the finish line.” inks from this episode:  Clinical Research News Massive Bio US National Library of Medicine: Clinical Trials Cancer Moonshot Program A New Approach to Simplifying and Harmonizing Cancer Clinical Trials-Standardizing Eligibility Criteria 

Jason LaRoche, Director of Clinical Innovation at Janssen Pharmaceuticals, speaks with host Deborah Borfitz about the global efforts launched to shrink the carbon footprint in the clinical trial and healthcare spaces. “If the global healthcare sector were a country, it would be the fifth largest emitter of greenhouse gases, and clinical research is a contributor,” explains LaRoche. In this episode, LaRoche discusses the pre-competitive space designed to inventory individual trials and their greenhouse gas (GHG) emissions to predict the total GHGs for future studies. He also talks about the semi-public database created to share GHG findings across the industry, how regulators and research organizations worldwide are taking action to diminish their carbon footprint, and the standalone project he developed to significantly reduce the massive waste generated from wearable health devices. Links from this episode:  Clinical Research News Janssen Global Sustainable Healthcare Coalition The Pistoia Alliance   

Pregnant women have consistently been underrepresented in clinical trials. With pregnancy studies posing significant risks to the mother and fetus, requiring extensive follow-up procedures, and potentially jeopardizing market approvals, many pharmaceutical companies avoid this demographic almost entirely. As a result, healthcare providers often struggle to access data regarding drug safety in pregnancy, preventing them from administering the best care possible. “Pregnant people make decisions in a vacuum of evidence. Very often, their healthcare providers don't know the evidence, so the women actually make the decision and take the risk that everyone else is ignoring. I think that has to stop,” says podcast guest Dr. Anna David, obstetrician and director of the University College London Institute for Women's Health.  In this episode, host Deborah Borfitz speaks with David about the obstacles facing pregnant patients in today's medical landscape and the past and present strides made to increase their representation in clinical research. David also talks about her work creating the first standardized vocabulary for drug safety and maternal-fetal adverse events, how COVID-19 changed the industry's perspective regarding pregnancy studies, and the novel trials currently fostering change across the globe.Links from this episode:  Clinical Research News University College London UCL EGA Institute for Women's Health Innovative Medicines Initiative ConcePTION Project Accelerating Innovation for Mothers International Council for Harmonisation Healthy Mum, Healthy Baby, Healthy Future Paediatric Investigation Plan (PIP) Maternal and Fetal Adverse Event Terminology 

Pharmacists demonstrate tremendous expertise in drug counseling and dispensation, so it seems undeniable that they should play a prominent role in clinical research. Surprisingly, their skill sets are rarely used in clinical trials. That's why Founder and CEO Gerald Finken created RxE2, a community-based decentralized trial technology company spearheaded by pharmacists, offering primary stakeholders their rightful seat at the clinical research table. In this episode, host Deborah Borfitz speaks with Finken about the challenges of delivering a new clinical trial concept and how the industry could benefit if pharmacists had more influence. He says, “I firmly believe that if pharmacists were involved, some of the issues that we're having today in clinical trials wouldn't exist. I don't think recruitment would be a problem. I don't think adherence and compliance would be a problem because pharmacists are medication experts who are trained to counsel patients and find out things real-time.” Finken also talks about the industry's response to his new venture and the company's plans to scale in the future.  Links from this episode:  Clinical Research News RxE2 American Pharmacists Association American Association of Pharmaceutical Scientists 

Real-world data certainly plays a substantial role in understanding human health and disease. However, scientists find it increasingly difficult to extract research-specific data from massive unstructured and uncoded data sets. “What we are seeing now is a more proactive anticipatory mission to connect multiple repositories of health data and to enable a strongly de-identified, but fully anonymized, data set to be available for research questions,” Dipak Kalra, President of The European Institute for Innovation through Health Data, tells host Deborah Borfitz. In this episode, Kalra speaks about the rise of research data networks and the facilitation of more effective and affordable research. He provides details about the growing challenges facing research teams and the new regulations imposed by the European Commission. Finally, Kalra shares his thoughts on how COVID changed the public's perception of health data and encouraged quick and innovative knowledge sharing. “The pandemic is a situation from which we can learn and on which we must build because we would be negligent if we don't,” warns Kalra. “The pandemic has shown how important it is to learn from big data in near to real-time in a way that absolutely transcends country boundaries.” Links from this episode:  Clinical Research News The European Institute for Innovation through Health Data General Data Protection Regulation (GDPR) European Health Data Space

ClinEco–a clinical trial ecosystem and market network designed to streamline the process of identifying and selecting clinical trial partners–is the first of its kind. Co-founders Dr. Marina Filshtinsky, SVP of Strategy and Product Development, and Micah Lieberman, VP of Community and Business Development, speak with Deborah Borfitz, Clinical Research News senior writer and podcast host, about the new platform's aim to revolutionize the way stakeholders navigate the clinical trial space. ClinEco reduces costs and increases study speeds by eliminating inefficiencies. “Identifying, validating, and contacting vendors and partners for clinical trials is a well-known bottleneck. The process is time-consuming, labor-intensive, inefficient, and expensive,” explains Filshtinsky. Hear the founders speak about creating a feature-rich platform that adds value over time and their goals for the network's launch and beyond.  Links from this episode:  Clinical Research News ClinEco SCOPE: Summit for Clinical Ops Executives New Study from Tufts Center for the Study of Drug Development Establishes Benchmarks for Vendor Qualification Process Barrett International: Leaders in Clinical Research Training World's First Clinical Trials Ecosystem and Marketplace About To Open 

Jasmine Smith, CEO, and Dr. Deborah Duong, CTO, of Rejuve.AI help patients achieve a healthy and extended life expectancy regardless of economic standing. Rejuve is the world's first decentralized AI longevity research network that provides equitable health and wellness solutions. The platform focuses on treatment accessibility, patient-centric research, data ownership, and fair labor. It also operates as an economy of clinical data researchers and contributors who retain ownership of their work. Contributors provide data and Rejuve's blockchain serves as a distributed ledger to keep patient data safe, ensure transparent data transactions, and maintain clear data ownership. Links from this episode:  Clinical Research News Rejuve.AI PharmaLedger Project   

Ken Getz and Clinical Research News Senior Science Writer, Deborah Borfitz, explore patient engagement. Getz, Executive Director & Research Professor at the Tufts Center for the Study of Drug Development (CSDD), shares what research has revealed about patient engagement efforts, where we're stuck in a rut, a crucial misalignment in the industry's view of patient engagement, and what clinical research participants actually want. Scope of Things Links:  Tufts Center for the Study of Drug Development Clinical Research News Scope Summit 

The pandemic has certainly been a turning point for decentralized trials, and Craig Lipset, co-chair of the Decentralized Trials and Research Alliance (DTRA) says the reasons are clear: the industry's risk balance has changed, he tells Deborah Borfitz, Clinical Research News senior writer and host of the new Scope of Things podcast. Now decentralized approaches to trials have become counter measures to the risky pandemic when patients couldn't travel to sites. “Decentralized” is an umbrella term, Lipset explains, that encompasses both processes and technology—not just a lot of tech. A decentralized approach will impact how and where people participate, prioritizing flexibility, diversity, and expanding accessible geographies. 

The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News Senior Writer 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.