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…", Dr. Jenny Devenport, Global Head of Methods, Collaboration, and Outreach at Roche, joins Dr. Scott Berry for a detailed discussion on career evolution, statistical culture, and communication in the pharmaceutical industry.

As part of our 2025 Simulation Guided Trial Design series, Kert Viele designs a Phase II trial with multiple dose strengths using a dose response model in this webinar.

Tom Parke presents two simple Phase II trials in this Simulation Guided Trial Design webinar. In the first trial example, he designs a Phase II trial with two arms and stopping for futility. In the second example, he designs a Phase II trial with three arms and arm dropping.

In this webinar that is a part of our 2025 Simulation Guided Trial Design series, Elias Meyer designs an advanced Phase I trial that includes open enrollment, backfilling, and targeting efficacy as well as toxicity.