FDA updates guidance for adaptive clinical trial reporting
The US Food and Drug Administration has announced new guidance for drug applications that include results from adaptive clinical trials.
The US Food and Drug Administration (FDA) has released new guidance for sponsors and applicants submitting drug or licensing applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic.
The guidance is intended for the submission of investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs) or supplemental applications.
The ‘Adaptive Design’ guidance is updated from the 2018 draft guidance, which contains revisions to the Bayesian subsection of the document, providing clarification on the pre-specification principle for adaptive design.
The document describes important principles for designing, conducting and reporting the results from a clinical trial.
The guidance also includes advice on the types of information to submit in order to facilitate FDA evaluations, including Bayesian adaptive and complex trials that rely on computer simulations for their design.
Adaptive design clinical trials allow for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial.