Chung Woo Kyung, Huh Ki Young, Park Jiyeon, Oh Jaeseong, Yu Kyung-Sang
Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.
Department of Pharmacology, Jeju National University College of Medicine, Jeju, Korea.
Transl Clin Pharmacol. 2024 Mar;32(1):30-40. doi: 10.12793/tcp.2024.32.e1. Epub 2024 Feb 20.
Clinical trials have evolved with digital technologies and tend towards patient-centricity. A multi-stakeholder approach is needed to address the emerging complexities in clinical trials. In particular, the introduction of digital technologies and an emphasis on patient-centricity are the major trends in clinical trials. In response, we established a public-private partnership-based organization named Advanced Regulatory Innovation for Clinical Trials Transformation (ARICTT). Eleven organizations in total, from academia, industry, and regulatory agencies, participate in ARICTT. Based on multi-stakeholder collaboration from academia, industry, and government/regulatory bodies, we collected and prioritized current topics in clinical trials based on an internal survey. We established a three-year roadmap with axes that were termed , , , , , and . In addition, we planned the development of recommendations based on real-world cases with feasibility studies. We developed appropriate organizational structure to fulfill the roadmap of ARICTT. The selected topics were decentralized clinical trials during the first year, followed by the three topics that were awarded the highest priority according to the internal survey: advances in the informed consent process, supporting sites using digital technology, and an effective recruitment strategy. We developed a case-based recommendation paper presenting an overview of the regulatory landscape and practical considerations with explanatory cases. We also designed and conducted fully decentralized trials to evaluate considerations in real-world settings for the selected topics. Overall engagement and communication were supported by the online platform and annual symposiums. In conclusion, we established a multi-stakeholder, public-private partnership-based organization to accelerate the transformation of clinical trials.
临床试验已随着数字技术不断发展，并趋向于以患者为中心。需要采用多利益相关方的方法来应对临床试验中出现的复杂性。特别是，数字技术的引入和对以患者为中心的强调是临床试验的主要趋势。作为回应，我们成立了一个基于公私伙伴关系的组织，名为临床试验转型高级监管创新组织（ARICTT）。总共有来自学术界、行业和监管机构的11个组织参与了ARICTT。基于学术界、行业和政府/监管机构的多利益相关方合作，我们通过内部调查收集了临床试验中的当前主题并确定了优先顺序。我们制定了一个为期三年的路线图，其轴被称为 、 、 、 、 和 。此外，我们计划根据具有可行性研究的实际案例制定建议。我们开发了适当的组织结构以实现ARICTT的路线图。第一年选定的主题是去中心化临床试验，随后是根据内部调查确定的三个优先级最高的主题：知情同意过程的进展、使用数字技术支持试验点以及有效的招募策略。我们撰写了一份基于案例的推荐文件，介绍了监管情况概述以及带有解释性案例的实际考量。我们还设计并开展了完全去中心化的试验，以评估选定主题在现实环境中的考量因素。在线平台和年度研讨会为整体参与和沟通提供了支持。总之，我们成立了一个基于多利益相关方、公私伙伴关系的组织，以加速临床试验的转型。
