In a new draft guidance, the US Food and Drug Administration (FDA) provided recommendations for multiregional clinical trials (MRCTs) in oncology, encouraging sponsors to ensure the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 existing guidance documents related to this topic, by providing additional recommendations for the planning, design, conduct, and analysis of an oncology MRCT that may facilitate FDA’s assessment of applicability of the data to the US population with the cancer being investigated and to US medical practice,” the agency said…
