October 25, 2018
The Food and Drug Administration (FDA) released an updated draft guidance to industry in early October entitled, “Adaptive Designs for Clinical Trials of Drugs and Biologics: Guidance for Industry.”
The draft guidance reviews best practices for trial design, analysis, and reporting of clinical trials using different adaptive design strategies. The public is invited to submit comments by November 30th.
Adaptive clinical trials are designed to change in response to an interim analysis. Unlike non – adaptive clinical trials, an adaptive trial might close a treatment arm, might increase or decrease the sample size, or might change the randomization allocation. Adaptive clinical trials can increase statistical efficiency, can be more appealing to patients and families, and can increase generalizability of trial results. Adaptive trials also pose risks – increased Type 1 error and possible bias.
The draft guidance recommends that sponsors engage early with the FDA about possible adaptive clinical trials. Specifying the design and decision rules in advance are critical to avoid error and bias. Restricting access to interim trial results is important to avoid changing the behavior of the sponsor, contract research organization (CRO), clinical trial sites, or study participants. Analysis plans must account for the adaptive design and should consider the use of simulations in planning.
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