Coronavirus Disease 2019 (COVID-19) Clinical Trial Oversight at a Major Academic Medical Center: Approach of Michigan Medicine. (11th May 2020)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Clinical infectious diseases. Volume 71:Number 16(2020)
• Page Start: 2187
• Page End: 2190
• Publication Date: 2020-05-11
• Subjects: COVID-19 -- randomized clinical trial -- research ethics -- informed consent -- ethics; Communicable diseases -- Periodicals; 616.905
• DOI: 10.1093/cid/ciaa560
• Languages: English
• ISSNs: 1058-4838

Abstract

Abstract: 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. Abstract : Here we share the approach and instruments of the University of Michigan regarding how to determine which COVID-19 randomized clinical trials have the best chance of benefiting patients and how to recruit participants.