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.