Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
Drug Discov Today. 2024 Nov;29(11):104180. doi: 10.1016/j.drudis.2024.104180. Epub 2024 Sep 14.
Methodological and operational clinical trial innovation is needed to address key challenges associated with clinical trials, including limited generalizability and (s)low recruitment rates. In this article, we discuss how appropriate implementation of innovative clinical trial approaches can be facilitated by a timely identification of, and response to, emerging situations and innovation by regulators (i.e. regulatory readiness) using decentralized clinical trial (DCT) approaches - in which trial activities are moved closer to participants and away from the investigative sites - as a case study example. Specifically, we discuss how explorative research (e.g. using regulatory sandboxes) can enable the collection of data on the usefulness of DCT approaches. Additionally, we argue that DCT approaches should be evaluated similarly to conventional clinical trials.
需要在方法学和操作层面进行临床试验创新，以解决临床试验面临的关键挑战，包括试验结果的普遍适用性有限和（或）招募速度较慢。本文以分散式临床试验（DCT）方法为例，讨论了监管机构（即监管准备就绪）如何通过及时识别和应对新出现的情况和创新，促进创新临床试验方法的适当实施。在 DCT 方法中，试验活动更接近参与者，远离研究现场。具体而言，我们讨论了探索性研究（例如使用监管沙盒）如何能够收集关于 DCT 方法有用性的数据。此外，我们认为应该以与传统临床试验类似的方式评估 DCT 方法。
