What happens when DC policy, FDA buzzwords, and real-world site pain all collide? In this episode, Brad and Denali sit down with Anthony Corso, VP of Public Policy at Veeva, to unpack the chaos and opportunity in today's "clinical research renaissance."
We dig into: - Real-time clinical trials and the mysterious rise (and fizzle?) of the FDA's Trialblazer initiative - Why "real-time" safety data is mostly a fantasy at the site level - One-and-done Phase 3 trials, master protocols, and how complexity keeps getting pushed onto sites and patients - The quiet policy moves around fair market value, participant stipends, and how trial income can cost people their benefits - ONC, EHRs, and the dream (or nightmare) of auto-matching patients to clinicaltrials.gov - Why e-consent and e-source still aren't standard, and how misaligned incentives keep innovation stuck - The real-world impact of trials: from oncology patients gaining years of life to the grind sites face just to keep the lights on
If you care about where clinical trials are actually headed – beyond the press releases – this one gets into the messy middle: policy, tech, regulators, CROs, sites, and the patients caught in the system.
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