Adaptive design allows for planned modifications to a clinical study based on accumulating data, while maintaining the trial’s integrity and validity. When properly implemented, adaptive design can reduce resource requirements and/or increase the chance of study success.
The guidance was issued to encourage companies to consider the use of adaptive design in their clinical trials. It is part of the FDA’s on-going efforts to improve access to new devices by strengthening and streamlining the clinical trial enterprise.
Comments and suggestions regarding this draft guidance can be submitted directly to the FDA. The comment period will be open for 90 days.