E20 Adaptive Designs for Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "E20 Adaptive Designs for Clinical Trials." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide a transparent and harmonized set of recommendations for clinical trials with an adaptive design. The draft guidance focuses on principles for the planning, conduct, analysis, and interpretation of clinical trials with an adaptive design that aim to confirm the efficacy and support the benefit-risk assessment of a treatment. The draft guidance emphasizes principles that are critical for ensuring clinical trials produce reliable and interpretable results and that involve specific considerations with use of an adaptive design.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.