FDA Releases Draft Guidance for Industry titled “Adaptive Designs for Clinical Trials of Drugs and Biologics”- Drug Information Update

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance titled, “Adaptive Design for Clinical Trials of Drugs and Biologics” for public comments. This guidance will help sponsors of investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications develop appropriate adaptive clinical trial designs to support the effectiveness and safety of a drug or biologic. When finalized, this guidance will represent FDA’s current thinking on this topic. 

Adaptive clinical designs may streamline drug development programs by saving time and reducing costs. This guidance describes the advantages of adaptive designs in a variety of situations and offers recommendations on the basic principles for designing, conducting, and reporting the results from an adaptive clinical trial, which are critical to the acceptance of adaptive designs in a regulatory setting.

For more information, please review the guidance