In this video we look at designing Group Sequential trials for confirmatory phase 3 trials, where the trial includes interims to stop early for efficacy and futility.

In this video we look at the issues around designing Phase 1 Dose Escalation trials in oncology, where the aim is to explore increasing dose levels up to a limiting rate of toxicities.

On September 28, 2023, Kert Viele will moderate a panel at the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, discussing time trends in ongoing platform trials using real interim analyses from the PRINCIPLE and REMAP-CAP trials, focusing on their impact on clinical trial analyses, modeling adjustments, and the complexities of additive versus interactive time trends.

Berry Consultants is sponsoring the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop from September 27-29 in Rockville, MD, where several team members will be presenting, and attendees can find more information and register on the ASA Workshop Website.

In his blog, Kert Viele discusses the importance of trial design in Bayesian analysis, emphasizing that while conclusions drawn from completed experiments remain consistent regardless of interim analyses, the design of the trial significantly impacts expected utilities, and optimal designs can enhance trial performance.

Public live Zoom webinars on "Introduction to Adaptive Trial Designs using FACTS" are scheduled for October and November.