Kurt Viele, a partner at Berry Consultants and expert in adaptive clinical trial designs, dives into the ICH E20 draft guidance's implications. He emphasizes the need for clear justification in adaptive trials and explores the distinctions between Bayesian and frequentist methods. The discussion highlights real-world applications, like the Sepsis ACT trial, and critiques areas of the guidance that may pose challenges. With practical insights on regulatory dialogue, operational biases, and future trends, Kurt offers valuable advice for researchers navigating this evolving landscape.
