An adaptive clinical trial evaluates a treatment or medical device by observing outcomes on a prescribed schedule, and modifying parameters of the trial protocol in accord with those observations. Modifications may include dosage, sample size and patient selection criteria. Importantly, adaptation schedule and processes are pre-specified in the trial protocol.
More information about adaptive designs can be found here:
|EUPATI||Document about the use of adaptive designs in clinical drug research from the EUropean Patients’ Academy on Therapeutic Innovation (EUPATI)|
|FDA||US Food and Drug Administration (FDA) draft document: Guidance for industry: Adaptive design clinical trials for drugs and biologics|