USA – FDA drafts guidance on multiregional clinical trials in oncology

In a new draft guidance [Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs], the US Food and Drug Administration (FDA) provided recommendations for multiregional clinical trials (MRCTs) in oncology, encouraging sponsors to ensure the results of trials in global oncology clinical development programs that support a marketing application are interpretable to patients in the US. “This guidance expands on principles described in FDA’s exist...