Drugs

Guide on Oncology Multiregional Clinical Trials

FDA has released a draft guidance entitled “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs (CDP).” The document provides sponsors with recommendations for conducting multiregional clinical trials (MRCTs) whose data are intended to support applications for oncologic drugs. The agency describes an MRCT as a trial that is conducted in more than one geographical region under a single protocol.

“The FDA encourages sponsors to pursue multiregional clinical trials, but stresses that such trials should be conducted within the appropriate context,” Oncology Center of Excellence director Richard Pazdur is quoted in a release as saying. “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. The new draft guidance, when finalized, will not only support the agency’s review of data generated from multiregional clinical trials, but also help sponsors improve the generalizability and applicability of results from these trials to the U.S. population and to U.S. medical practice.”

The guidance was crafted to address “decreasing proportions of U.S. participants included in oncology MRCTs,” according to the agency, which may limit the ability to determine if an observed treatment outcome in the study is consistent between U.S. enrolled participants and the overall study population in the MRCT.

The draft guidance expands on current principles for MRCTs and, when finalized, will provide additional recommendations “to improve the planning, design, conduct and analysis of future oncology MRCTs,” the agency says. “It also will aid sponsors in planning multiregional clinical development programs that consider the agency’s evaluation of trial results that can be applied to the intended use population in the U.S., and to U.S. standard oncological care.”

According to the guidance, sponsors should carefully consider whether a CDP conducted using a multiregional approach is appropriate due to scientific, clinical, and other factors. For example, it says, “known differences in the prevalence, presentation, etiology, or severity of a cancer may exist across countries or regions and can impact applicability to the U.S. population and to U.S. medical practice.” It says sponsors should consider the following factors:

patient-related factors (e.g., exposure to disease risk factors, genetic ancestral background)
disease-related factors (e.g., prevalence of disease subtypes, the frequency and distribution of certain oncogenesis molecular drivers in the population).
healthcare system factors (e.g., access to health care, including specialized oncology care, cancer screening practices, treatment availability and affordability) which can affect previous treatments received and available treatments following the clinical investigation.
socio-cultural factors (e.g., diets, cultural beliefs about using alternative cancer-treating therapies

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