In this episode of “In the Interim…,” host Dr. Scott Berry examines the challenge of communicating complex statistical concepts to non-statistical audiences.

Today, the FDA published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping sponsors make better use of available data and conduct more efficient clinical trials.

In this episode of “In the Interim…,” host Dr. Scott Berry examines the challenge of communicating complex statistical concepts to non-statistical audiences.

In recent public discussion, FDA leaders have indicated a possible shift from the longstanding two-trial requirement for substantial evidence of drug efficacy to acceptance of a single, highly stringent trial. Dr. Scott Berry and Dr. Kert Viele, on the "In the Interim..." podcast, analyze the statistical, regulatory, and scientific implications and highlight those in this blog.

In this episode of "In the Interim…", host Dr. Scott Berry and frequent co-host Dr. Kert Viele, Senior Statistical Scientist at Berry Consultants, analyze the potential shift in FDA regulatory policy from requiring two independent trials to accepting a single trial as sufficient for “substantial evidence” in drug approvals.

In this episode of "In the Interim…", host Dr. Scott Berry and frequent co-host Dr. Kert Viele, Senior Statistical Scientist at Berry Consultants, analyze the potential shift in FDA regulatory policy from requiring two independent trials to accepting a single trial as sufficient for “substantial evidence” in drug approvals.