Benda Norbert, Brannath Werner, Bretz Frank, Burger Hans-Ulrich, Friede Tim, Maurer Willi, Wang Sue-Jane
Federal Institute for Drugs and Medical Devices, Bonn, Germany.
J Biopharm Stat. 2010 Nov;20(6):1098-112. doi: 10.1080/10543406.2010.514447.
In the midst of gaining more experience in pursuing scientifically sound approaches of adaptive designs in clinical trials, a panel discussion with international representatives from industry, academia, and regulatory agencies was held at the Basel Biometric Society Spring Conference, March 12, 2010. The goal was to develop some consensus among industry, government, and academic statisticians concerning requirements and methods for adaptive designs in clinical trials. In this paper, we summarize the panelists' perspectives given at that session.
在临床试验中获取更多关于采用科学合理的适应性设计方法的经验之际,2010年3月12日于巴塞尔生物统计学会春季会议上举行了一场由来自行业、学术界和监管机构的国际代表参与的小组讨论。目的是在行业、政府和学术统计学家之间就临床试验适应性设计的要求和方法达成一些共识。在本文中,我们总结了该场会议上小组成员的观点。