Using FACTS to design a two-arm study where differences in adherence between the arms drive the effect size. Uncertainty in the effect size prompted spacing the interims to correspond to different sample sizes resulting in irregular interim analyses. Using a uses a finite mixture model from previous data on the analysis endpoint to justify the irregular interims.

Is this the most complex and most successful trial ever designed and run? Looking at the AWARD 5 trial for what became Eli Lilly’s Trulicity drug. The drug used response adaptive randomization, longitudinal modelling, dose response modelling and a utility function combining 4 endpoints. The trial selected a successful dose and switched early from phase 2 to a successful phase 3.

Berry Consultants is hosting a free 6-week public webinar series on "Case Studies in using FACTS to design Clinical Trials" from October 17th to November 21st, 2024, featuring live demonstrations of trial design using their simulation software, with registration available for each session at their website.

Berry Consultants is proud to be a Principal Sponsor of the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop in Rockville, MD from September 25th-27th, and invites attendees to visit their exhibit booth to discover their trial design, implementation, and software solutions.

In this September 6, 2024 episode by SciPod Health and Medicine, SciPod summarizes the recent paper “Lecanemab for Patients with Early Alzheimer Disease: Bayesian Analysis of a Phase 2b Dose-Finding Randomized Clinical Trial” by Dr. Donald Berry (Founder of Berry Consultants) and Scott Berry (President of Berry Consultants).

In the September 6, 2024 episode of SciPod Health and Medicine, the podcast discusses a paper on Lecanemab for early Alzheimer’s disease by Dr.