Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Drug Discov Today. 2022 Oct;27(10):103326. doi: 10.1016/j.drudis.2022.07.011. Epub 2022 Jul 20.
Decentralized clinical trials (DCTs) can be a valuable addition to the clinical trial landscape. However, the practice of DCTs is dependent on a regulatory system designed for conventional (site-based) trials. This study provides insight into the ethics review of DCTs. A 'mock ethics review' was performed in which members of European ethics committees (ECs) and national competent authorities (NCAs) discussed and reviewed a DCT protocol. Respondents expressed hesitancy toward DCTs and focused on potential risks and burdens. We advise to address these aspects explicitly when submitting a DCT protocol. We propose that both the benefits and risks of DCTs should be carefully monitored to advance the review and practice of this innovative approach to ethically optimize drug development.
去中心化临床试验 (DCT) 可以为临床试验领域增添宝贵价值。然而，DCT 的实践依赖于专为传统（基于站点）试验设计的监管系统。本研究深入探讨了 DCT 的伦理审查。我们进行了一次“模拟伦理审查”，让欧洲伦理委员会 (EC) 成员和国家主管当局 (NCA) 讨论和审查了一项 DCT 方案。受访者对 DCT 表示犹豫不决，重点关注潜在的风险和负担。我们建议在提交 DCT 方案时明确解决这些方面。我们建议，应仔细监测 DCT 的效益和风险，以推进这种创新方法的审查和实践，从而在伦理方面优化药物开发。
