Revision: FDA Guideline on Adaptive Designs for Clinical Trials

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

As a part of new or revised guidance documents on clinical trial design, the FDA published the revised draft guidance on "Adaptive Designs for Clinical Trials of Drugs and Biologics". This document will replace the 2010 draft guidance for industry "Adaptive Design Clinical Trials for Drugs and Biologics". It is supposed to support sponsors of investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications.
The document's aim is to provide recommendations on the appropriate use of adaptive designs for clinical trials in order to provide evidence of the effectiveness and safety of a drug or biologic. Adaptive Designs are defined "as a clinical trial design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial."

The revised document includes important principles for designing, conducting, and reporting the results of an adaptive clinical trial and provides details about the information needed by the authorities in order to evaluate the results of clinical trials with adaptive designs. The main focus is on adaptive designs for clinical trials intended to support the effectiveness and safety of drugs. Therefore, the guidance covers the following bullets:

• DESCRIPTION OF AND MOTIVATION FOR ADAPTIVE DESIGNS
• PRINCIPLES FOR ADAPTIVE DESIGNS
• ADAPTIVE DESIGNS BASED ON NON-COMPARATIVE DATA
• ADAPTIVE DESIGNS BASED ON COMPARATIVE DATA
• SPECIAL CONSIDERATIONS AND TOPICS
• MAINTAINING TRIAL INTEGRITY
• REGULATORY CONSIDERATIONS

For more details please read the complete revised guideline on  Adaptive Designs for Clinical Trials of Drugs and Biologics.