Best Practices For Adaptive Trial Designs Continue To Evolve

Data Monitoring Committees are one option to look at interim data and implement pre-planned adaptations to clinical trials, but the new duty could conflict with DMC’s safety responsibility, participants at a DIA conference note.

Adaptive trials are becoming more common in development programs for medical products, but sponsors and regulators are still grappling with how to effectively implement such designs and identify best practices.

When adaptive designs require that someone have access to interim study results in order to implement the algorithm that directs when and how to modify elements of the design while...

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