TY - JOUR T1 - Adaptive trials in clinical research: Scientific and ethical issues to consider AU - van der Graaf R, Roes KB, van Delden JM Y1 - 2012/06/13 N1 - 10.1001/jama.2012.6380 JO - JAMA SP - 2379 EP - 2380 VL - 307 IS - 22 N2 - 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 SN - 0098-7484 M3 - doi: 10.1001/jama.2012.6380 UR - http://dx.doi.org/10.1001/jama.2012.6380 ER -