On May 18th, FDA issued a draft guidance on Adaptive Design for Medical Device Clinical Studies. This is the first time FDA formally endorsed the use of use of adaptive clinical trial design for medical devices. This guidance follows a previous guidance for use of adaptive clinical trials for testing drugs and biologics released more than 5 years ago. Together these two guidance clarify any doubts one may have for use of adaptive trials for all FDA-regulated products.
Adaptive trials have become very popular for drugs and biologics in the last few years due to the potential to reduce resource requirements and/or increase the chance of study success. However, such trial design is not used as often for medical devices due to misunderstanding of FDA’s expectations. This guidance clarifies several issues such as when to use such trial design, the various types of adaptive designs acceptable for medical device trials, and ways to ensure trial integrity and data reliability. Unlike drug trials where FDA discourages adaptations in registration trials, it encourages such design for pivotal studies to support medical device approval. This is a welcome change. FDA strongly recommends that the sponsors of adaptive trials meet and discuss the design with FDA before implementation. Discussing the plans, proposed interim analyses, and statistical design with FDA in a meeting could greatly increase the odds of success in execution of such innovative trial designs.
Article Source: Adaptive trials in Medical device guidance
Adaptive trial in Drugs and Biologics
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