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

Authors
  • Spector-Bagdady, Kayte1
  • Higgins, Peter D R2
  • Aaronson, Keith D3
  • Birk, Judy4
  • Flaherty, Kevin R5
  • Gregg, Kevin S6
  • Hyzy, Robert C5
  • Kaul, Daniel R6
  • Lauring, Adam S6, 7
  • Magee, John C8
  • Meurer, William J9, 10
  • Park, Pauline K8
  • Scott, Phillip10
  • Lok, Anna S2
  • 1 Department of Obstetrics & Gynecology and the Center for Bioethics & Social Sciences in Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • 2 Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • 3 Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • 4 Office of Research, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • 5 Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • 6 Department of Internal Medicine, Division of Infectious Diseases, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • 7 Department of Microbiology and Immunology, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • 8 Department of Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • 9 Department of Neurology, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • 10 Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.
Type
Published Article
Journal
Clinical Infectious Diseases
Publisher
Oxford University Press
Publication Date
Nov 19, 2020
Volume
71
Issue
16
Pages
2187–2190
Identifiers
DOI: 10.1093/cid/ciaa560
PMID: 32392334
Source
Medline
Keywords
Language
English
License
Unknown

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. © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: [email protected]

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