Issue Date: September 16, 2024
Issued by: Oncology Center of Excellence
Topic(s): Clinical – Medical
Status: Draft
Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs
This guidance provides recommendations to sponsors who are planning global clinical development programs for drugs intended to treat cancer, on improving the evidence obtained from one or more multiregional clinical trials (MRCTs) intended to support a marketing application. 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 U.S. population with the cancer being investigated and to U.S. medical practice.
Download the Guidance Document
