Zhaohui Su, VP of Biostatistics at Ontada, shared a post on LinkedIn:
“I am pleased to share this practical article on the FDA’s Draft Guidance on Bayesian Methods. It highlights dynamic borrowing and prior discounting, including the thoughtful use of external clinical and real-world data, as decision‑critical tools that regulators now expect to be prespecified, stress‑tested, and transparently justified.
Bayesian methods are evolving beyond their roles in dose finding and exploratory analyses, and are now increasingly used to support primary inference when applied rigorously.
The implications for small biotechs are especially compelling: smarter trial designs, more efficient use of limited patient populations, and faster learning-all without compromising regulatory credibility.
Thanks to Jessica Cordes for translating complex guidance into concrete, actionable insights. This is a must-read for anyone involved in designing modern clinical trials.”
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