F. Hoffmann-La Roche, Basel, Switzerland.
Roche products Limited, Welwyn Garden City, UK.
Trials. 2022 Sep 30;23(1):833. doi: 10.1186/s13063-022-06707-w.
The COVID-19 pandemic has had a devastating impact on individuals and multiple aspects of our society including healthcare and clinical research. The silver lining is that the pandemic also served as a catalyst for wider adoption of innovative approaches in clinical research, notably the use of mobile or remote services, and digital technologies. Regulators, clinical study investigators, clinical study participants, sponsors, and other stakeholders collaborated to adopt measures that ensured safe participation in clinical studies whilst maintaining study integrity. In this article, we propose a regulatory framework for assessing fit-for-purpose innovative approaches in clinical research based on Roche/Genentech's experience during the COVID-19 pandemic with the aim to inform and encourage broader implementation of patient-centric and sustainable innovation in clinical research. Our goal is to contribute to ongoing discussions on introducing innovative approaches in clinical trials and eventually the development of globally harmonised guidelines.
COVID-19 大流行对个人和我们社会的多个方面都产生了毁灭性的影响，包括医疗保健和临床研究。好的一面是，这场大流行也成为了在临床研究中更广泛采用创新方法的催化剂，特别是使用移动或远程服务和数字技术。监管机构、临床研究调查人员、临床研究参与者、赞助商和其他利益相关者合作采取措施，确保在保持研究完整性的同时安全参与临床研究。在本文中，我们基于罗氏/基因泰克在 COVID-19 大流行期间的经验，提出了一个评估临床研究中创新方法是否适用的监管框架，旨在为更广泛地实施以患者为中心和可持续的临床研究创新提供信息和鼓励。我们的目标是为正在进行的关于在临床试验中引入创新方法的讨论做出贡献，并最终制定全球协调一致的指南。
