Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp and University Hospital Antwerp, Antwerp, Belgium.
Julius Center for Health Science and Primary Care, University Medical Center Utrecht, Utrecht University, Netherlands; Department of Intensive Care Medicine, University Medical Center Utrecht, Utrecht University, Netherlands.
Lancet Infect Dis. 2022 May;22(5):e153-e158. doi: 10.1016/S1473-3099(21)00705-2. Epub 2021 Dec 21.
Clinicians have worked feverishly to treat patients with COVID-19 while also carrying out clinical research studies. We discuss how the clinical research community responded to the pandemic in Europe, what lessons were learned, and provide recommendations for future clinical research response during pandemics. We focused on two platform trials: RECOVERY and REMAP-CAP. Both trials were able to enrol patients very rapidly during the beginning of the pandemic because of pre-established structures and procedures, and because they share simple execution and flexibility to adjust when evidence emergences. However, contracting, regulatory hurdles, and competition with (often inadequately designed or underpowered) national trials was a major challenge in several EU countries. We recommend the creation of structures and partnerships that facilitate prioritisation of clinical research, simplification of clinical trial delivery, development of digital models and procedures for data collection and sharing, development of a mechanism to rapidly leverage pandemic funding and to connect EU funding with national funding, and investment in clinical trial networks, platform trials, and master protocols. Finally, the future pandemic clinical research response of the EU should be embedded in the global response. We believe that globally connected clinical trial networks will be essential to respond more effectively to future infectious diseases outbreaks.
临床医生一直在努力治疗 COVID-19 患者,同时开展临床研究。我们讨论了欧洲临床研究界如何应对这一大流行病,从中吸取了哪些经验教训,并为未来大流行期间的临床研究应对提供了建议。我们重点关注了两项平台试验:RECOVERY 和 REMAP-CAP。由于预先建立的结构和程序,以及它们具有简单的执行和灵活性,可以根据证据的出现进行调整,这两项试验在大流行初期都能够非常迅速地招募患者。然而,在几个欧盟国家,合同、监管障碍以及与(通常设计不当或效力不足的)国家试验的竞争是一个主要挑战。我们建议建立结构和伙伴关系,以促进临床研究的优先排序,简化临床试验的实施,开发用于数据收集和共享的数字模型和程序,建立一个机制来快速利用大流行病资金,并将欧盟资金与国家资金联系起来,以及投资于临床试验网络、平台试验和主方案。最后,欧盟未来的大流行临床研究应对应该嵌入全球应对之中。我们相信,全球互联的临床试验网络对于更有效地应对未来的传染病爆发至关重要。