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Coronavirus Disease 2019 (COVID-19) Clinical Trial Oversight at a Major Academic Medical Center: Approach of Michigan Medicine.
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.
Afiliação
  • 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.
  • Higgins PDR; Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • Aaronson KD; Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • Birk J; Office of Research, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • Flaherty KR; Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • Gregg KS; Department of Internal Medicine, Division of Infectious Diseases, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • Hyzy RC; Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • Kaul DR; Department of Internal Medicine, Division of Infectious Diseases, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • Lauring AS; Department of Internal Medicine, Division of Infectious Diseases, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • Magee JC; Department of Microbiology and Immunology, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • Meurer WJ; Department of Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • Park PK; Department of Neurology, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • Scott P; Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.
  • Lok AS; Department of Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.
Clin Infect Dis ; 71(16): 2187-2190, 2020 11 19.
Article em En | MEDLINE | ID: mdl-32392334
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ensaios Clínicos Controlados Aleatórios como Assunto / Seleção de Pacientes / Centros Médicos Acadêmicos / COVID-19 Tipo de estudo: Clinical_trials Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Clin Infect Dis Assunto da revista: DOENCAS TRANSMISSIVEIS Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ensaios Clínicos Controlados Aleatórios como Assunto / Seleção de Pacientes / Centros Médicos Acadêmicos / COVID-19 Tipo de estudo: Clinical_trials Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Clin Infect Dis Assunto da revista: DOENCAS TRANSMISSIVEIS Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Estados Unidos