Advanced Clinical Trials and Clinical Research

Adaptive Trial Models

Adaptive trial models offer dynamic flexibility in clinical study design by allowing modifications based on interim data. This session explores the core principles of adaptive designs, including dose escalation, sample size re-estimation, and treatment arm adjustments. Attendees will gain insights into how adaptive trials can accelerate development timelines, reduce resource use, and improve decision-making. Regulatory perspectives from FDA and EMA on adaptive protocol acceptability will be addressed, along with statistical methodologies that ensure control of Type I error and preserve trial integrity. Case examples from oncology, rare diseases, and pandemic response trials will illustrate the power of real-time adaptations. Attendees will also learn about platform trials and Bayesian approaches. This session is ideal for researchers and sponsors aiming to integrate smarter, more efficient designs into their clinical development strategy.