The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...
FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.
ACT Brief: Moving Beyond AI Pilots, FDA Advances Bayesian Trials, and Sites Strained by Trial Design
In today’s ACT Brief, we examine what will separate sponsors that scale AI beyond pilots in 2026, break down the FDA’s new ...
US FDA issues guidance on modernizing statistical methods for clinical trials: Maryland Wednesday, January 14, 2026, 09:00 Hrs [IST] The US Food and Drug Administration today publ ...
Bayesian methods have emerged as a pivotal framework in the design and analysis of clinical trials, offering a systematic approach for updating evidence as new data become available. By utilising ...
Bayesian prediction and modeling have emerged as transformative tools in the design and management of clinical trials. By integrating prior knowledge with accumulating trial data, Bayesian methods ...
With populations aging, chronic diseases becoming more prevalent, and global health experts warning of potential pandemics, the need for rapid therapeutic development has reached unprecedented levels.
We review Bayesian and Bayesian decision theoretic approaches to subgroup analysis and applications to subgroup-based adaptive clinical trial designs. Subgroup analysis refers to inference about ...
The way late-onset toxicities are managed can affect trial outcomes and participant safety. Specifically, participants often might not have completed their entire follow-up period to observe any ...
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