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Adaptive trials in clinical research: scientific and ethical issues to consider.

, , and . JAMA : the journal of the American Medical Association, 307 (22): 2379-80 (June 2012)6707<m:linebreak></m:linebreak>Disseny; Dissenys adaptatius; RCT; Ètica.
DOI: 10.1001/jama.2012.6380

Abstract

Adaptive trials also have certain ethical advantages because fewer participants are assigned to the inferior procedure or drug compared with trials with fixed designs. For instance, in the ASTIN trial, researchers conducted an adaptive phase 2 dose response trial to determine whether a neutrophil inhibitory factor improved recovery in patients with acute ischemic stroke; it did not. However, this trial needed to enroll 966 patients, compared with the need to enroll 1080 patients if a traditional design had been used. Furthermore, the adaptive design made it possible to stop the trial early for futility.1

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