Author Sabrina Paganoni, MD, PhD, of Massachusetts General Hospital and Harvard Medical School, discusses results of the first 4 drug regimens from the HEALEY ALS platform trial and how this study design makes efficient use of resources.

This month’s webinar will be on the topic, “Why simulate? Can clinical trial simulation really improve the strategic decision making in drug development?”

Berry Consultants has hired Dr. Mike Krams as a Senior Medical Scientist in Europe, bringing extensive experience in clinical development strategy and adaptive trials to the team.

Berry Consultants has released FACTS 7.1, featuring enhancements such as concurrent control comparisons, conditional power calculations, new analysis options for dichotomous endpoints, integration with the R package "Airship" for flexible graphing, improved Bayesian dose escalation consistency, and various interface improvements.

Using FACTS to design a large 2-arm safety study, borrowing information from a previous trial, exploring alternative endpoints and using an enriched population.

A Phase 2 dose finding study using a Bayesian dose response model and response adaptive randomization across multiple doses and treatment regimens. Includes a presentation of the interim analyses from the actual trial that lead to the successful phase 3 trial of Lecanemab.