Abstract

The spread of COVID-19 has created tremendous challenges to ongoing clinical studies essential to finding effective treatments and cures for a myriad of diseases, with some studies having suspended enrollment altogether. This perspective article focuses on the loss of power in clinical studies disrupted by the pandemic. It introduces an innovative use of the recently developed propensity score-integrated approaches: salvaging those stopped studies for which restarting enrollment is not feasible, by integrating external patients with data already collected to recover the loss of study power due to the premature stopping. A hypothetical example is provided to illustrate how to implement these methods while preserving study integrity.

摘要

COVID-19 的传播给正在进行的临床研究带来了巨大挑战，这些临床研究对于寻找多种疾病的有效治疗方法和治愈方法至关重要，一些研究完全暂停了招募。这篇观点文章重点关注因大流行而中断的临床研究中的权力损失。它引入了对最近开发的倾向评分整合方法的创新使用：通过将外部患者与已收集的数据整合以恢复由于过早停止而丧失的研究能力，从而挽救那些无法重新开始注册的已停止研究。提供了一个假设示例来说明如何在保持研究完整性的同时实施这些方法。