The FDA has released new draft guidance outlining the use of Bayesian methodologies in clinical trials for drugs and biologics.
The guidance is intended to help sponsors apply modern statistical techniques to improve trial efficiency, particularly in rare and pediatric conditions where patient populations are limited, according to a Jan. 12 agency news release. Bayesian analysis allows researchers to combine data from a current study with prior information to assess safety and efficacy.
Potential uses for Bayesian methods include adaptive trial decisions, dose selection, incorporation of real-world evidence, subgroup analyses and supporting primary endpoints.
FDA Commissioner Marty Makary said the guidance aims to address high costs and long timelines in drug development and support faster access to treatments. It also fulfills a commitment under the Prescription Drug User Fee Act VII to enhance the agency’s capacity for reviewing complex, innovative trial designs.
