FDA Update: New Guidance on Adaptive Clinical Trials
The FDA recently released a draft guidance document that addresses adaptive clinical trial design, which can accelerate the process of drug development and help researchers allocate resources more efficiently while maintaining scientific and regulatory standards. The document is open for comments until Dec. 1, 2025.
The draft guidance, E20 Adaptive Designs for Clinical Trials, prepared by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), intends to provide a transparent and integrated set of recommendations for clinical trials with adaptive designs.
All clinical trials aim to facilitate the benefit-risk analysis of a treatment, validate a treatment’s effectiveness and produce accurate and interpretable results. Adaptive trial designs make room for flexibility while the trial is in progress. This flexibility helps accelerate timelines that often span 6 to 10 years, allowing sponsors and research teams to optimize resources without compromising quality and consistency.
Unlike fixed trial designs, adaptive designs allow for planned modifications to studies after they’ve begun, based on data gathered from trial participants. For example, even with careful planning, there may be uncertainty at the planning stage about certain design aspects, such as appropriate sample size. An adaptive design would allow changes to sample size while a trial is in progress. A non-adaptive design wouldn’t.
The proposed guidance offers a roadmap for conducting adaptive clinical trials, including principles for planning, conducting, analyzing and interpreting trial results using adaptive designs.
How do you see adaptive trial design shaping your approach to development or compliance planning? The E20 Adaptive Designs for Clinical Trials draft guidance is non-binding and open for comments until Dec.1, 2025. Click here to read the draft guidance.
At ASG, we view this as a positive step toward smarter trial execution and stronger regulatory alignment, both of which are essential to ensuring therapies reach patients faster and with greater confidence in the science behind them.
