In today's blog, Dr. Kert Viele breaks down the most crucial updates of the draft guidance on "Master Protocols for Drug and Biological Product Development," specifically focusing on the new details surrounding basket trials, control group requirements, and the heavy integration of the FDA's draft Bayesian guidance.

On the latest episode of "In the Interim…", Dr. Scott Berry provides an empirical examination of two recent JAMA trials: TRACK (low-dose rivaroxaban in advanced kidney disease) and VICTORY (IV vitamin C in severe burn injury).

On the latest episode of "In the Interim…", Dr. Scott Berry provides an empirical examination of two recent JAMA trials: TRACK (low-dose rivaroxaban in advanced kidney disease) and VICTORY (IV vitamin C in severe burn injury).

In this week's blog, Dr. Kert Viele discusses his thoughts on the RAR literature and the current state of RAR in practical clinical trials. He focuses on general principles that have emerged in the literature, the nuts and bolts of constructing and tuning RAR designs, and operational issues.

In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele examine response-adaptive randomization (RAR) in clinical trials, dissecting its statistical rationale, common criticisms, and implementation challenges.

In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele examine response-adaptive randomization (RAR) in clinical trials, dissecting its statistical rationale, common criticisms, and implementation challenges.