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Guidance on Planning/Design of Multi-Regional Trials


Federal Register Notice: FDA is making available a draft guidance entitled E17 General Principles for Planning and Design of Multi-Regional Clinical Trials. It was prepared under the auspices of the International Council for Harmonization. Multi-regional clinical trials (MRCTs) conducted according to the guidance will investigate treatment effects in overall populations with multiple ethnic factors (intrinsic and extrinsic factors as described in the ICH guidance entitled E5 Ethnic Factors in the Acceptability of Foreign Clinical Data (E5 guidance)) The trials will evaluate the consistency of treatment effects across populations. The draft guidance is intended to increase the acceptability of data from MRCTs as the primary source of evidence supporting marketing approval in global regulatory submissions and to thereby facilitate more efficient drug development and earlier access to medicines. To download this guidance, click here. To view this notice, click here.