In the announcement, FDA Commissioner Mackary said, “Bayesian methodologies help address two of the biggest problems of drug ...

What physicians should know about FDA's new proposed guidance ...

The FDA’s new draft guidance on Bayesian methods in clinical trials has been hailed by some as a breakthrough that could speed drug development. But statisticians and researchers are divided on ...

Industry groups and drugmakers want the US Food and Drug Administration (FDA) to explicitly clarify that Bayesian statistical methods can be used for products beyond those intended for children and ...

Cytel Inc., an advanced analytics leader providing quantitative insights to decision-makers in clinical investigation, has announced the launch of East Alloy®. This new platform is a web-native ...

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 ...