As rare disease trials face persistent feasibility challenges, Bayesian designs are gaining momentum by enabling more ...

The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing subjectivity into what should be an objective process.

Jessica Ritsick, Yifan Wang, Ph.D. Our FDA: Drug & Device Team analyzes the Food and Drug Administration’s new guidance on Bayesian approaches to innovative drug trials, providing greater clarity on ...

The FDA has released draft guidance on how sponsors can use Bayesian models for clinical trials.

The Simon two-stage minimax design is a popular statistical design used in Phase II clinical trials. The analysis of the data arising from the design typically involves the use of frequentist ...