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

Authors :
Robert C. Hyzy
Kayte Spector-Bagdady
William J. Meurer
Pauline K Park
Daniel R. Kaul
Judy Birk
Kevin R. Flaherty
Peter D.R. Higgins
John C. Magee
Keith D. Aaronson
Kevin S. Gregg
Adam S. Lauring
Phillip A. Scott
Anna S. Lok
Source :
Clinical Infectious Diseases
Publication Year :
2020
Publisher :
Oxford University Press (OUP), 2020.

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.

Details

Language :
English
ISSN :
15376591 and 10584838
Database :
OpenAIRE
Journal :
Clinical Infectious Diseases
Accession number :
edsair.doi.dedup.....abefd5dcf71ce302a6b1290859a7d98d
Full Text :
https://doi.org/10.1093/cid/ciaa560