The Scope of Things

• Episode: 45 - Doug Bain on Streamlining Clinical Trials

  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.

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• Episode 44 - SCOPE Europe 2025 on AI Literacy Training, Reducing Excess Data Collection, Combating Superbugs

  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.

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• Episode: 43 - Overcoming the Deadlock in Patient Recruitment With Christine Senn

  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.

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• Episode: 42 - Myeloma Research on a Global Scale with Joseph Mikhael

  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.

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• Episode: 41 - How Non-Profits Are Filling Unique Roles in Clinical Research

  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.

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