Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Department of Medicine, Division of Cardiology, Queen's University, Kingston, Ontario, K7L 2V7, Canada.
Trials. 2021 Mar 24;22(1):229. doi: 10.1186/s13063-021-05165-0.
Along with its heavy toll of morbidity and mortality, the coronavirus disease 2019 (COVID-19) pandemic exposed several limitations of the current global research response. The slow and inefficient process of carrying out traditional randomized clinical trials led regulatory authorities to hastily approve treatments and tests without sufficient evidence of safety and efficacy.We here outline issues with the current research platform, summarize shortcomings of traditional randomized clinical trials particularly apparent at the time of pandemics, and highlight the advantages of pragmatic clinical trials as an alternative to rapidly generate the needed clinical evidence. We further discuss barriers and challenges to pragmatic clinical trials implementation and explore opportunities for research institutions and regulatory authorities to facilitate widespread adoption of this vital research tool.As a subsequent wave of COVID-19, and/or another epidemic, are all but inevitable in our lifetime, we must ensure that our research infrastructure is conducive to carrying out pragmatic clinical trials to expeditiously generate the needed evidence and blunt the epidemic's toll on human lives and livelihoods.
与 2019 年冠状病毒病（COVID-19）大流行造成的高发病率和死亡率一起，还暴露了当前全球研究应对措施的几个局限性。开展传统随机临床试验的缓慢和低效过程导致监管机构在没有足够安全性和疗效证据的情况下匆忙批准治疗方法和检测方法。我们在此概述当前研究平台存在的问题，总结传统随机临床试验的缺陷，特别是在大流行期间的明显缺陷，并强调实用临床试验作为快速生成所需临床证据的替代方法的优势。我们进一步讨论实施实用临床试验的障碍和挑战，并探讨研究机构和监管机构为促进广泛采用这一重要研究工具而创造的机会。随着 COVID-19 的下一波浪潮，以及/或另一场大流行，在我们的有生之年几乎是不可避免的，我们必须确保我们的研究基础设施有利于开展实用临床试验，迅速生成所需的证据，并减轻大流行对人类生命和生计的影响。
