Beck Andrew E, Kampman Melissa, Huynh Cindy, Simon Craig, Plueschke Kelly, Cohet Catherine, Verpillat Patrice, Robinson Kelly, Arlett Peter
Health Canada, Health Products and Food Branch, Marketed Health Products Directorate, Ottawa, Ontario, Canada.
European Medicines Agency, Data Analytics and Methods Task Force, Amsterdam, The Netherlands.
Clin Pharmacol Ther. 2025 Feb;117(2):368-373. doi: 10.1002/cpt.3457. Epub 2024 Oct 21.
The International Coalition of Medicines Regulatory Authorities (ICMRA), comprising 38 global medicines regulatory authorities, collaborates on shared challenges, notably during the COVID-19 pandemic. This article focuses on the ICMRA COVID-19 Real-World Evidence (RWE) and Observational Studies Working Group. The Working Group aimed to address challenges related to RWE and observational studies during the pandemic, resulting in impactful studies and ICMRA statements on international collaboration for RWE and COVID-19 vaccine safety. Reflecting on 3 years of collaboration, the Working Group surveyed members for insights, and recommendations were formulated to enhance research preparedness, collaboration, and response to future public health emergencies. The lessons learned highlight the importance of global collaborations, governance structures for rapid decision-making, and effective utilization of existing networks. Recommendations include the establishment of an international governance structure, a "coalition of the willing" for swift research collaboration, dedicated sub-groups, periodic workshops, common protocols, joint timelines, and data model templates, leveraging existing infrastructure, and strengthening outreach for transparency and engagement. The Working Group envisions repurposing into an RWE strategic and operational entity, contributing to global public health emergency response mechanisms. In conclusion, the Working Group's success lies in effective communication, collaborative research, and leveraging existing infrastructure, with ongoing contributions to global emergency response mechanisms.
由38个全球药品监管机构组成的国际药品监管机构联盟（ICMRA），在共同面临的挑战上开展合作，尤其是在新冠疫情期间。本文聚焦于ICMRA新冠疫情真实世界证据（RWE）与观察性研究工作组。该工作组旨在应对疫情期间与真实世界证据和观察性研究相关的挑战，开展了有影响力的研究，并就真实世界证据及新冠疫苗安全性方面的国际合作发表了ICMRA声明。在回顾3年合作历程时，该工作组向成员进行了调研以获取见解，并制定了相关建议，以加强研究准备、合作以及对未来突发公共卫生事件的应对。汲取的经验教训凸显了全球合作、快速决策治理结构以及有效利用现有网络的重要性。建议包括建立国际治理结构、一个用于迅速开展研究合作的“意愿联盟”、专门小组、定期研讨会、通用方案、联合时间表和数据模型模板，利用现有基础设施，并加强宣传以提高透明度和参与度。该工作组设想转型为一个真实世界证据战略和运营实体，为全球突发公共卫生事件应对机制做出贡献。总之，该工作组的成功在于有效沟通、合作研究以及利用现有基础设施，并持续为全球应急响应机制做出贡献。
