Lessons Learned from Coronavirus Disease 2019 (COVID-19) Therapies: Critical Perspectives From the Infectious Diseases Society of America (IDSA) COVID-19 Treatment Guideline Panel

Adarsh Bhimraj, Rebecca L. Morgan, Amy Hirsch Shumaker, Lindsey Baden, Vincent Chi-Chung Cheng, Kathryn M. Edwards, Rajesh T. Gandhi, Jason C. Gallagher, William J. Muller, John C. O'Horo, Shmuel Shoham, Dana Swartzberg Wollins, Yngve Falck-Ytter

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)1691-1695
Number of pages5
JournalClinical Infectious Diseases
Volume74
Issue number9
DOIs
StatePublished - May 1 2022

Keywords

  • COVID-19
  • IDSA
  • SARS CoV-2
  • clinical trials
  • coronavirus
  • pandemics
  • therapeutics

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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