Now Is The Time: Adaptive Clinical Trials — How To Address The Challenges And Reap The Benefits
Clinical trials are the most costly and time-consuming part of drug development, and success rates are low. One of the leading reasons for this is the inherent uncertainty and complexity in trial design. Most clinical trials do not enable using the data generated as the trial progresses, which leads to escalating costs and time, as well as higher patient dropouts. Adaptive clinical trials enable modifications throughout the trial, based on accumulative data, resulting in a higher probability of success, and maximizing the treatment benefits for patients, while reducing costs and minimizing time to market. Shifts and advancements in recent years, such as regulator leniency and digitalization of clinical operations, have opened the door to the adoption of adaptive design, and the advantages of such trials are clear and proven. However, adaptive trials are still the exception (specifically phases II & III), since they are complex, less intuitive, and bring on operational challenges. These challenges need to be addressed to enable wider adoption.
Join this 60-minute panel discussion to hear our experts discuss the potential impact and challenges of adaptive design and how these challenges can be addressed to unlock the benefits of adaptive design, enabling the conduct of more efficient and successful clinical trials.
Learning Objectives:
- Addressing the statistical and operational challenges of adaptive trials and ways to overcome them.
- Assessing the benefits and impact of adaptive trial design.
- Leveraging machine learning to harness accumulated data during the trial for ongoing optimization.
- Bridging the knowledge gap by allowing all stakeholders to make informed decisions to meet their trial objectives.
- The need for comprehensive solutions to support both the design and the ongoing adaptation logic during trial execution.
Speakers:
Dr Michael Ropacki, Chief Medical Officer (CMO), Head of CNS Clinical Development, Oryzon
Varun Nagpal, Regional Director Medical Affairs, Merck
Linnea Olsson, Director, Clinical Operations, Mirati — A Bristol Myers Squibb Company
Dr. Raviv Pryluk, CEO and Co-Founder, PhaseV
