Adaptive phase 2/3 designs for oncology drug development-Time to hedge

被引：4

作者：

Chen, Cong ^{[1
,3
]}

Rubin, Eric H. ^{[2
]}

机构：

[1] Merck & Co Inc, Biostat & Res Decis Sci, Rahway, NJ 07065 USA

[2] Merck & Co Inc, Oncol Early Dev, Rahway, NJ 07065 USA

[3] MAILSTOP UG-1CD44,351 North Sumneytown Pike, North Wales, PA 19454 USA

来源：

CONTEMPORARY CLINICAL TRIALS | 2023年 / 125卷

关键词：

Oncology; Immunotherapy; Adaptive design;

D O I：

10.1016/j.cct.2022.107047

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Randomized-controlled Phase 2 trials are routinely skipped in oncology drug development in favor of directly going to confirmatory Phase 3 after signal-detection post dose-finding in Phase 1. With improved standard-of -care, this speed-oriented aggressive approach is not sustainable. It is time to apply the state-of-art adaptive 2 -in-1 Phase 2/3 designs to mitigate the risk of costly Phase 3 failures and allow a study to choose the optimal path to success.

引用

页数：2

共 5 条

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