To help clinical trial sponsors who are planning global cancer studies best position themselves for FDA approval, the agency has released draft guidance for conducting multiregional clinical trials in oncology. The draft includes considerations for selecting clinical trial sites, analyzing data and incorporating regional information about the disease and available treatments.
"The FDA encourages sponsors to pursue multiregional clinical trials, but stresses that such trials should be conducted within the appropriate context," Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence, said in a Sept. 16 release. "It is important that data from multiregional clinical trials are applicable to patients in the United States who may use the drug and our current standards of oncological care.”
If a company is planning one multiregional trial to support FDA approval, the agency recommends conducting the trial across continents rather than in a single country or geographic area, according to the guidance. The FDA also suggests that trial sponsors pre-specify how they will evaluate regional effects in their data analysis and provide an explanation of why they chose their proposed method.
Multiregional cancer trials have been steadily including fewer and fewer U.S. participants, the agency noted in the release, which the FDA warns may restrict the ability to draw conclusions about how the tested drug will perform in the country’s population.
Comments on the draft guidance, titled “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs,” can be submitted until Monday, Nov. 18.