Works in Progress Podcast How to speed up clinical trials
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Apr 22, 2026 
Ruxandra Teslo, Fellow at Renaissance Philanthropy and regulatory policy analyst, discusses why drug development is slowing despite better science. Short conversations cover surrogate endpoints like bone mineral density, why companies shift trials to Australia, regulatory drag from IRBs and opaque FDA guidance, and reforms such as platform trials, safe harbors, and surrogate validation funding.
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Surrogate Endpoints Can Resurrect Neglected Fields
- Surrogate endpoints can shrink trial time and cost dramatically by replacing hard outcomes with measurable biomarkers.
- Example: approving bone mineral density as an osteoporosis surrogate transformed a near-dead field into active investment.
Surrogate Endpoints Are Undervalidated And Opaque
- Surrogate endpoints are often poorly validated because validation requires costly prospective trials and lacks commercial incentives.
- The FDA holds internal evidence but public re-analyses frequently can't verify surrogate-clinical outcome links.
Run Rapid Early Human Experiments For Faster Learning
- Prioritize small, iterative early‑stage human studies to maintain 'clinic in the loop' learning rather than treating all human studies as large-scale trials.
- Ruxandra cites CAR-T evolution from tiny experiments to later pivotal trials as the model.