自从2015年的药品管制改革以来，中国大大简化了许多新型抗癌药物的批准。在本文中，我们回顾了2015年至2021年中国通过的抗癌药物的关键临床试验设计。总体而言，我们发现79个新分子实体（NME）具有140种抗癌指示剂。其中，适应性随机对照试验（RCT）设计在关键临床试验中最常用（n=83，49%），其次是单臂试验设计（n=52，30%）和传统RCT试验设计（n=36，21%）。与传统RCT设计相比，单臂试验和适应性RCT能够显著缩短临床试验的持续时间。我们的研究结果表明，中国广泛使用新型临床试验设计以加速抗癌药物的上市。简言之，为了解决未满足的临床需求，相比传统随机对照试验，中国鼓励使用更加灵活的临床试验设计，包括单臂试验和适应性设计。版权所有 © Elsevier Ltd. 2023。保留所有权利。

China has greatly facilitated the approval of many novel anticancer drugs since the drug regulatory reform in 2015. Here, we review the clinical trial designs used in pivotal clinical trials for approved anticancer agents in China from 2015 to 2021. Overall, 79 new molecular entities (NMEs) with 140 anticancer indications were identified. Of these, adaptive randomized controlled trial (RCT) designs were used most frequently in pivotal clinical trials (n=83, 49%), followed by single-arm design trials (n=52, 30%) and traditional RCT design trials (n=36, 21%). The single-arm trials and adaptive RCTs can significantly shorten clinical trial duration compared with traditional RCT designs. Our findings show that novel clinical trial designs were widely used in China to accelerate the launch of anticancer drugs. Teaser: To address unmet clinical needs, more flexible clinical trial designs were encouraged for novel anticancer drugs in China, including single-arm trials and adaptive designs, as compared with traditional randomized controlled trials.Copyright © 2023 Elsevier Ltd. All rights reserved.