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

Academic Medical Centers COVID-19 / therapy Humans Informed Consent Michigan Patient Selection / ethics Randomized Controlled Trials as Topic / standards Time Factors Treatment Outcome
COVID-19 ethics informed consent randomized clinical trial research ethics

Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213

Informations de publication

Date de publication:
19 11 2020
Historique:
received: 05 05 2020
accepted: 08 05 2020
pubmed: 12 5 2020
medline: 15 12 2020
entrez: 12 5 2020
Statut: ppublish

Résumé

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.

Identifiants

DOI: 10.1093/cid/ciaa560 PMID: 32392334 PMC: PMC7239254
pubmed: 32392334
pii: 5835855
doi: 10.1093/cid/ciaa560
pmc: PMC7239254
doi:

Types de publication

Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2187-2190

Subventions

Organisme : NCATS NIH HHS
ID : UL1 TR002240
Pays : United States

Informations de copyright

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Auteurs

Kayte Spector-Bagdady (K)

Department of Obstetrics & Gynecology and the Center for Bioethics & Social Sciences in Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Peter D R Higgins (PDR)

Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Keith D Aaronson (KD)

Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Judy Birk (J)

Office of Research, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Kevin R Flaherty (KR)

Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Kevin S Gregg (KS)

Department of Internal Medicine, Division of Infectious Diseases, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Robert C Hyzy (RC)

Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Daniel R Kaul (DR)

Department of Internal Medicine, Division of Infectious Diseases, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Adam S Lauring (AS)

Department of Internal Medicine, Division of Infectious Diseases, University of Michigan Medical School, Ann Arbor, Michigan, USA.
Department of Microbiology and Immunology, University of Michigan Medical School, Ann Arbor, Michigan, USA.

John C Magee (JC)

Department of Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.

William J Meurer (WJ)

Department of Neurology, University of Michigan Medical School, Ann Arbor, Michigan, USA.
Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Pauline K Park (PK)

Department of Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Phillip Scott (P)

Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Anna S Lok (AS)

Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Michigan Medical School, Ann Arbor, Michigan, USA.

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Classifications MeSH

questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Établissements de santé › Centres hospitaliers universitaires › Coronavirus Disease 2019 (COVID-19) Clinical...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › Pneumopathie infectieuse › Pneumopathie virale › COVID-19 › Coronavirus Disease 2019 (COVID-19) Clinical...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Coronavirus Disease 2019 (COVID-19) Clinical...
questionsmedicales.fr › Organisations et économie des soins de santé › Contrôle social formel › Jurisprudence › Consentement libre et éclairé › Coronavirus Disease 2019 (COVID-19) Clinical...
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › États-Unis › États du Centre-Ouest des États-Unis › Michigan › Coronavirus Disease 2019 (COVID-19) Clinical...
questionsmedicales.fr › Administration des services de santé › Gestion des soins aux patients › Sélection de patients › Coronavirus Disease 2019 (COVID-19) Clinical...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Coronavirus Disease 2019 (COVID-19) Clinical...
questionsmedicales.fr › Phénomènes physiques › Temps › Facteurs temps › Coronavirus Disease 2019 (COVID-19) Clinical...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Coronavirus Disease 2019 (COVID-19) Clinical...