The U.S. Food and Drug Administration has issued three final guidances to industry regarding cancer clinical trials to facilitate continued advancement in cancer prevention, detection, research, and patient care.
The first guidance, “Inclusion of Older Adults in Cancer Clinical Trials,” provides recommendations to sponsors and institutional review boards for including older adult patients, aged 65 years and older, in the clinical trials of drugs for the treatment of cancer. It also includes recommendations for trial design, recruitment strategies, information collection, and developing and reporting more discrete age groups to encourage enrollment of this historically excluded population.
The second guidance for industry “Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics,” provides advice on designing and conducting trials with multiple expansion cohorts to assess many different aspects of a drug in a single clinical trial, to efficiently expedite the clinical development of the drug.
Finally, the “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics” guidance addresses master protocol design including information on what sponsors should submit to the FDA as part of these trial design approaches, and how sponsors should interact with the FDA. These clinical trial designs can allow for more than one investigational drug or biologic, more than one disease type, or more than one patient population, to be evaluated under a single clinical trial structure. Because of the complexity of these trials and the potential regulatory impact, it’s important that the FDA is providing this guidance on how to conduct well designed trials that protect patient safety and obtain quality data needed to support drug approval.