Considerations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs." This draft guidance provides recommendations to sponsors who are planning global clinical development programs for drugs intended to treat cancer, on improving the evidence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 This draft guidance expands on principles described in FDA's existing guidance documents related to this topic, by providing additional recommendations for the planning, design,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.
Abstract as published in the Federal Register.
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