038 - "Clinical Trials" with Dan Sfera
Dan Sfera, founder of Yuma Clinical Trials and author of the Comprehensive Guide to Clinical Research, explains the operational realities of clinical trials, highlighting the conflict between 'patient-centric' technology and actual patient burden. He details the high screen-failure rates in Phase 2 and 3 trials, the critical role of the Investigator's Form 1572, and the specific risks of investigational product mix-ups during randomization. Sfera also discusses the dynamics between sponsors, CROs, and sites, arguing that direct sponsor involvement often yields better outcomes than using rigid CROs.