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Joining this month’s episode of The Scope of Things is Joseph Kim, chief strategy officer of ProofPilot, who talks about his company’s first-ever CORE Symposium, where pharma pros shared practical solutions to age-old trial challenges. Kim provides a pragmatic viewpoint on the problematic trio of clinical trials—study execution, recruitment, and engagement—and what change agents are needed to pave the way forward and find an exit from the bottlenecks. Plus, host Deborah Borfitz delivers the latest on a planned mapping of clinical trial deserts, the high cost of accelerated FDA approvals, the best states for cancer research, the world’s first in-ear EEG system getting approved, and a new smartphone-based outcome measure for sleep studies.   News Roundup  Financial hurdles to trial enrollment  Study in the Journal of the National Comprehensive Cancer Network News on the Case Western Reserve University website  Accelerated cancer drug approvals  Study in BMJ Medicine Best states for cancer research  Blog on SmileHub website In-ear EEG devices  Article in Diagnostics World News Ecological momentary assessment in sleep-focused trial  Study in JAMA Network Open    Guest  Joseph Kim, chief strategy officer for ProofPilot  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.

Noninterventional studies in clinical research are underutilized in clinical research and inefficient. Dan Drozd, CMO of PicnicHealth, knows we can do better. With host Deborah Borfitz, Drozd discusses the issues and ramifications researchers face from the lack of noninterventional studies, offers tactics for raising the bar for evidence generation, and shares what he expects in the clinical research space in 2026 in this episode of the Scope of Things. Plus, Borfitz shares the latest news on an expanding good pharma score card, an entirely telehealth-based cancer trial, a novel online platform for bowel cancer research, improving patient-reported outcomes in cancer trials, a virtual clinical trial for psychedelics, and identifying Type 1 diabetes in the symptom-less window stage. Show Notes     News Roundup  Good Pharma Scorecard  Study in JAMA Internal Medicine News on the Yale Scool of Medicine website  Nationwide telehealth trial for cancer  News on The Ohio State University website Online platform for bowel cancer research  News on the Newcastle University website Patient-reported outcomes in cancer clinical trials  Paper in The Lancet Oncology News on the European Organisation for Research and Treatment of Cancer website Virtual clinical trial of psychedelics  Research article in Advanced Science Type 1 diabetes risk prediction testing  Study in The Lancet News on the University of Exeter website Guest  Dan Drozd, M.D., CMO of PicnicHealth  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.

Doug Bain, founder and consulting partner of ClinFlo, discusses his proposed regulatory blueprint for digital trials in the latest episode of The Scope of Things podcast. With host Deborah Borfitz, Bain delves into his strategy for turning 21 CFR Part 11 into a more practical regulation that streamlines rather than bogs down clinical trials, what would qualify someone to take on the role as a trusted third party (and what makes them trustworthy), and the new FDA administration’s modernization plan aligns—or squares—with his ideas. Plus, the latest news on a tool for detecting fraud and sampling bias in decentralized trials, technology for identifying potentially dangerous drugs before trials start, a novel women’s health and menopause initiative, a regenerative therapy for spinal cord injury, and a new oral treatment for preventing dementia.  Show Notes :   News Roundup Data collection tools for decentralized trials  MyTrials platform study in the Journal of Clinical and Translational Science  Real-time data integration tool  Press release on the Mount Sinai website Drug toxicity prediction  Article in EbioMedicine  Tufts Women’s Health and Menopause Initiative  News from Tufts University  Regenerative therapy for spinal cord injury  Article in Nature Oral treatment for preventing dementia  Press release from Aarhus University  Guest  Doug Bain, founder and consulting partner of UK-based ClinFlo    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 episode of the Scope of Things features an exclusive panel at SCOPE Europe 2025 covering regulatory requirements for AI literacy training, featuring industry executives Jonathan Crowther, head of the operational design center at Merck KGaA; Janie Hansen, global development information management, business systems transformation at Daiichi Sankyo; Francis Kendall, head of statistical programming, digital and data sciences at Biogen; and James Weatherall, vice president and chief data scientist of biopharmaceuticals R&D at AstraZeneca. Plus, host Deborah Borfitz gives the latest news on efforts to reduce excess data collection in studies, whole genome sequencing of breast cancer, a virus cocktail to combat superbugs, and more.  Show Notes News Roundup    Collaborative study on data collection in trials  News posted on the TransCelerate website Heart benefits of semaglutide  Study in The Lancet Whole genome sequencing of breast cancers  Study in The Lancet Oncology Pan-cancer immunotherapy heads to trials  Research article in Cell Article in Bio-IT World Promising NAD+ “youth molecule”  Review article in Nature Aging  Virus cocktail to combat superbugs  Article in Nature Microbiology AI annotates medical images  News posted on the MIT website Fitbits aid precision health  American Life in Realtime study in PNAS Nexus Latest from the Human Epilepsy Project  Study in JAMA Neurology Imposter study participants  Editorial in The BMJ Guests  Jonathan Crowther, Ph.D., Head, Operational Design Center, Merck KGaA, Darmstadt, Germany Janie Hansen, Global Development Information Management, Business Systems Transformation, Daiichi Sankyo Francis Kendall, Head of Statistical Programming, Digital and Data Sciences, Biogen James Weatherall, Ph.D., Vice President & Chief Data Scientist, BioPharmaceuticals R&D, AstraZeneca   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.

For decades, clinical trial recruitment has been the biggest challenge in the industry. Christine Senn, senior vice president of Site-Sponsor Innovation at Advarra, offers insights into why the struggle continues, such as delays in getting regulations updated after a quarter of a century, and how to overcome the deadlock in clinical trial recruitment that is tied to current obsolete marketing guidelines. Also, host Deborah Borfitz shares the latest on beta blockers, low dose aspirin lowering the risk of recurring colorectal cancer, repurposing drugs for breast cancer relapse prevention, remote participation research on why athletes and military members face higher ALS risk, and the first agentic AI platform for life sciences from Medable.  Show Notes  News Roundup  Rethinking beta blockers  Press release on the Mount Sinai website Subgroup analysis study in the European Heart Journal Aspirin lowers risk of colorectal cancer recurrence  Study in The New England Journal of Medicine  CLEVER study to prevent breast cancer relapse  Study in Nature Medicine News release on Penn Medicine website   Champion Insights ALS initiative  News release on Answer ALS website Medable’s Agent Studio  Press release on the Medable website Disseminating research findings  Systematic review in PLOS Medicine  Guest  Christine Senn, Ph.D., senior vice president of site-sponsor innovation at Advarra  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.

Joseph Mikhael, chief medical officer of The International Myeloma Foundation, and his organization are pulling all the stops to find a true cure for multiple myeloma, a rare and often fatal blood cancer. He shares the origins and mission of the Black Swan Research Initiative, a research project dedicated to preventing myeloma and finding a cure, and how global collaborators are contributing to multiple myeloma research. Also, host Deborah Borfitz delivers the latest news on ChatGPT determining trial eligibility, a questionable shortcut in rectal cancer drug trials, a new no-nausea weight loss remedy heading to trial, and more.  News Roundup  AI for stratifying Alzheimer’s patients  Study in Nature Communications  Questionable shortcut in rectal cancer drug trials  Investigation in JAMA Network Open ChatGPT determines trial eligibility  Paper in Machine Learning: Health Major trauma study to test hemorrhage treatment  News release by University of Colorado Anschutz Medical Campus New weight loss remedy soon heads to trials  News on Syracuse University website Study in Science Translational Medicine 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.

Children’s Tumor Foundation CEO Annette Bakker discusses what non-profit organizations uniquely bring to clinical research and new financial models sustaining their contribution. Plus, host Deborah Borfitz rounds up the latest news in clinical research: new funding approaches for ALS clinical trials, spatial biology to match patients to trials, a bio map of lung cancer tumor changes, improving diabetes treatment outcomes for patients in China, and more.   Show Notes  News Roundup    Fund of Adaptive Royalties  Research article in PLOS One TACIT algorithm matching patients to trials  Article in Nature Communications Mapping biomarkers linked to treatment resistance  Press release on the City of Hope website  Pragmatic diabetes trial in China  Paper about China-specific genetic risk score in Diabetologia News of trial launch on the University of Exeter website Cough medicine to slow dementia?  Study in JAMA Neurology Beating the EARL hurdles in the UK  Study in JAMA Network Open Guest  Annette Bakker, Ph.D., CEO of the Children's Tumor Foundation  Article in Clinical Research 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.

The latest on a trio of pragmatic trials for lung cancer treatment, the implementation of national-scale pharmacogenomic testing, an efficient approach to comparing commonly used intravenous fluids, improving access to gene therapy trials for a progressive heart condition, the landscape for Alzheimer’s disease studies, clinical trials that predict the most effective therapy, and the creation of AI agents for clinical research. Joining the discussion is Bethany Kwan, director of the Dissemination & Implementation Research Core at the Colorado Clinical & Translational Sciences Institute at the University of Colorado Anschutz Medical Campus, and Heather Smyth, research associate with the Center for Innovative Design and Analysis in the Colorado School of Public Health. They talk about the advancement of pragmatic clinical trials, how they differ from traditional studies, and how to handle the challenges that come with implementing them.    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 brings you the latest news on AI-recommended precision dosing, organoid drug testing aiding treatment selection for bowel cancer, an AI tool for stratifying lung cancer patients, using HIV drugs to treat Alzheimer’s disease, and the potential value of magic mushrooms to remedy the mood symptoms of Parkinson’s. Blythe Adamson, international head of outcomes research and evidence generation at Flatiron Health, also joins in to discuss groundbreaking work harmonizing patient-level real-world data across four countries to enable multinational oncology research.   News Roundup  CURATE.AI platform  Article in Clinical Research News Study in npj Precision Oncology   FORECAST-2 clinical trial  News on the Walter and Eliza Hall Institute website AI tool for sorting cancer patients  Study in Nature Communications  HIV drugs for Alzheimer’s protection  Study in Alzheimer’s & Dementia “Magic mushrooms” for Parkinson’s disease  Study in Neuropsychopharmacology Guest  Blythe Adamson, Ph.D., international head of outcomes research and evidence generation at Flatiron Health   Flatiron Health enabling multinational oncology researh – article in Bio-IT World  Subscribe to the podcast on Apple Podcasts and leave a review to support the show. Join us at Scope Europe on October 14-15 in Barcelona - use code SOT10 for an additional 10% discount.  GUEST BIO  Blythe Adamson, PhD, MPH, Head of Outcomes Research and Evidence Generation, International at Flatiron Health & Founder of Infectious Economics  Dr. Blythe Adamson is the head of international outcomes research and evidence generation at Flatiron Health.    As a visionary senior leader at Flatiron Health, her team pioneered deep learning language models for extraction of clinical details from EHR documents, breaking the limits of what was possible for humans to do alone. Learning from the experience of millions of patients with cancer, they generate evidence of treatment effectiveness and value used by governments around the world. Dr. Adamson co-invented a patented clinical decision-support tool, enabled by machine learning, that is used by cancer clinics to benefit patients.    She holds degrees in microbiology, epidemiology, and pharmaceutical economics with a focus on infectious disease prevention. Dr. Adamson has held roles at the Bill and Melinda Gates Foundation Institute for Disease Modeling, the NIAID HIV Vaccine Trials Network, and Flatiron Health.  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 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.