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.