Mayo Clinic and Mayo Foundation, Rochester, MN 55901, USA.
Contemp Clin Trials. 2013 Jul;35(2):128-37. doi: 10.1016/j.cct.2013.05.007. Epub 2013 May 22.
Sargent and Goldberg [1] proposed a randomized phase II flexible screening design (SG design) which took multiple characteristics of candidate regimens into consideration in selecting a regimen for further phase III testing. In this paper, we extend the SG design by including provisions for an interim analysis and/or a comparison to a historical control. By including a comparison with a historical control, a modified SG design not only identifies a more promising treatment but also assures that the regimen has a clinically meaningful level of efficacy as compared to a historical control. By including an interim analysis, a modified SG design could reduce the number of patients exposed to inferior treatment regimens. When compared to the original SG design, the modified designs increase the sample size moderately, but expand the utility of the flexible screening design substantially.
Sargent 和 Goldberg [1] 提出了一种随机的 II 期灵活筛选设计（SG 设计），该设计在选择用于进一步 III 期测试的方案时考虑了候选方案的多种特征。在本文中，我们通过纳入中期分析和/或与历史对照的比较来扩展 SG 设计。通过与历史对照比较，修改后的 SG 设计不仅可以确定更有前途的治疗方法，而且还可以确保与历史对照相比，该方案具有临床意义上的疗效水平。通过纳入中期分析，修改后的 SG 设计可以减少接受较差治疗方案的患者人数。与原始 SG 设计相比，修改后的设计适度增加了样本量，但大大扩展了灵活筛选设计的实用性。
