The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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.

In today’s ACT Brief, we examine what will separate sponsors that scale AI beyond pilots in 2026, break down the FDA’s new ...

The U.S. Food and Drug Administration (FDA) has issued new draft guidance modernizing statistical methodologies used in ...

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 ...

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 ...

Health care is undergoing an important and well-needed shift from a one-size-fits-all approach to more personalized, precise, patient-focused care. A similar approach needs to be implemented at scale ...

Biomarker-based clinical trials provide efficiencies during therapeutic development and form the foundation for precision medicine. These trials must generate information on both experimental ...

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 ...

ARLINGTON, Va.--(BUSINESS WIRE)--A Medical Device Innovation Consortium (MDIC) program today released a new framework that provides U.S. medical device companies a systematic approach for ...

Researchers at Mount Sinai launch a new AI platform to match more cancer patients with clinical trials, aiming to expand ...