Your browser doesn't support javascript.
loading
Lessons Learned from Coronavirus Disease 2019 (COVID-19) Therapies: Critical Perspectives From the Infectious Diseases Society of America (IDSA) COVID-19 Treatment Guideline Panel.
Bhimraj, Adarsh; Morgan, Rebecca L; Shumaker, Amy Hirsch; Baden, Lindsey; Cheng, Vincent C; Edwards, Kathryn M; Gandhi, Rajesh T; Gallagher, Jason C; Muller, William J; O'Horo, John C; Shoham, Shmuel; Wollins, Dana Swartzberg; Falck-Ytter, Yngve.
Afiliação
  • Bhimraj A; Department of Infectious Diseases, Cleveland Clinic, Cleveland, Ohio, USA.
  • Morgan RL; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
  • Shumaker AH; VA Northeast Ohio Healthcare System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
  • Baden L; Brigham and Women's Hospital, Boston, Massachusetts, USA.
  • Cheng VC; Department of Microbiology, Queen Mary Hospital, and Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.
  • Edwards KM; Division of Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
  • Gandhi RT; Infectious Diseases Division, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.
  • Gallagher JC; Department of Pharmacy Practice, Temple University, Philadelphia, Pennsylvania, USA.
  • Muller WJ; Division of Pediatric Infectious Diseases, Northwestern University, Chicago, Illinois, USA.
  • O'Horo JC; Division of Infectious Diseases, Joint Appointment Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota, USA.
  • Shoham S; Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Wollins DS; Infectious Diseases Society of America, Arlington, Virginia, USA.
  • Falck-Ytter Y; VA Northeast Ohio Healthcare System, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Clin Infect Dis ; 74(9): 1691-1695, 2022 05 03.
Article em En | MEDLINE | ID: mdl-34668008
ABSTRACT
Despite the challenges of the pandemic, there has been substantial progress with coronavirus disease 2019 (COVID-19) therapies. Pivotal COVID-19 trials like SOLIDARITY, RECOVERY, and ACCT-1 were rapidly conducted and data disseminated to support effective therapies. However, critical shortcomings remain on trial conduct, dissemination and interpretation of study results, and regulatory guidance in pandemic settings. The lessons that we learned have implications for both the current pandemic and future emerging infectious diseases. There is a need for establishing and standardizing clinical meaningful outcomes in therapeutic trials and for targeting defined populations and phenotypes that will most benefit from specific therapies. Standardized processes should be established for rapid and critical data review and dissemination to ensure scientific integrity. Clarity around the evidence standards needed for issuance of both emergency use authorization (EUA) and biologic license application (BLA) should be established and an infrastructure for executing rapid trials in epidemic settings maintained.
Assuntos
Palavras-chave

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Doenças Transmissíveis Emergentes / Tratamento Farmacológico da COVID-19 Tipo de estudo: Guideline Limite: Humans Idioma: En Revista: Clin Infect Dis Assunto da revista: DOENCAS TRANSMISSIVEIS Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Doenças Transmissíveis Emergentes / Tratamento Farmacológico da COVID-19 Tipo de estudo: Guideline Limite: Humans Idioma: En Revista: Clin Infect Dis Assunto da revista: DOENCAS TRANSMISSIVEIS Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos