Spector-Bagdady Kayte, Higgins Peter D R, Aaronson Keith D, Birk Judy, Flaherty Kevin R, Gregg Kevin S, Hyzy Robert C, Kaul Daniel R, Lauring Adam S, Magee John C, Meurer William J, Park Pauline K, Scott Phillip, Lok Anna S
Department of Obstetrics & Gynecology and the Center for Bioethics & Social Sciences in Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.
Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Michigan Medical School, Ann Arbor, Michigan, USA.
Clin Infect Dis. 2020 Nov 19;71(16):2187-2190. doi: 10.1093/cid/ciaa560.
Clinicians, eager to offer the best care in the absence of guiding data, have provided patients with coronavirus disease 2019 (COVID-19) diverse clinical interventions. This usage has led to perceptions of efficacy of some interventions that, while receiving media coverage, lack robust evidence. Moving forward, randomized controlled clinical trials are necessary to ensure that clinicians can treat patients effectively during this outbreak and the next. To do so, academic medical centers must address 2 key research issues: (1) how to effectively and efficiently determine which trials have the best chance of benefiting current and future patients and (2) how to establish a transparent and ethical process for subject recruitment while maintaining research integrity and without overburdening patients or staff. We share here the current methods used by Michigan Medicine to address these issues.
临床医生急于在缺乏指导性数据的情况下提供最佳治疗，于是为2019冠状病毒病（COVID-19）患者提供了各种临床干预措施。这种做法导致人们认为一些干预措施有效，尽管这些干预措施在媒体上得到了报道，但缺乏有力证据。展望未来，随机对照临床试验对于确保临床医生在此轮疫情及未来疫情期间能够有效治疗患者而言是必要的。为此，学术医疗中心必须解决两个关键研究问题：（1）如何有效且高效地确定哪些试验最有可能使当前和未来的患者受益；（2）如何建立一个透明且符合伦理的受试者招募流程，同时保持研究的完整性，且不给患者或工作人员造成过重负担。我们在此分享密歇根大学医学中心用于解决这些问题的当前方法。
