This draft guidance provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new ...

1 月 13 日，美国食品药品监督管理局（Food and Drug Administration, FDA）发布了一份指导草案，正式表态支持在药物和生物制品临床试验中使用贝叶斯方法论（Bayesian Methodology）。图 | ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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

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 ...

FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

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 in Structural Equation Modeling (SEM) represent a paradigm shift in statistical analysis, integrating prior beliefs with empirical data to derive robust parameter estimates. This ...