Guidance for Industry Adaptive Design Clinical Trials for Drugs and Biologies

摘要

This guidance provides sponsors and the review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologies Evaluation and Research (CBER) at the Food and Drug Administration (FDA) with information regarding adaptive designclinical trials when used in drug development programs.2 This guidance gives advice on topics such as (1) what aspects of adaptive design trials (i.e., clinical, statistical, regulatory) call for special consideration, (2) when to interact with FDA while planning and conducting adaptive design studies, (3) what information to include in the adaptive design for FDA review, and (4) issues to consider in the evaluation of a completed adaptive design study. This guidance is intended to assist sponsors in planning and conducting adaptive design clinical studies, and to facilitate an efficient FDA review.