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.