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Lessons Learned from COVID-19 Therapies: Critical Perspectives from the IDSA COVID-19 Treatment Guideline Panel
From the Abstract: "Despite the challenges of the pandemic, there has been substantial progress with COVID-19 [coronavirus disease 2019] 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 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."
Oxford University Press
Bhimraj, Adarsh; Morgan, Rebecca L.; Shumaker, Amy Hirsch . . .
2021
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Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19
From the Abstract: "There are many pharmacologic therapies that are being used or considered for treatment of COVID-19 [coronavirus disease 2019]. There is a need for frequently updated practice guidelines on their use, based on critical evaluation of rapidly emerging literature. [The objective of this paper is to] [d]evelop evidence-based rapid guidelines intended to support patients, clinicians and other health-care professionals in their decisions about treatment and management of patients with COVID-19."
Infectious Diseases Society of America
Bhimraj, Adarsh; Morgan, Rebecca L.; Shumaker, Amy Hirsch . . .
2020-04-13
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Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19 [Updated September 4, 2020]
From the Abstract: "There are many pharmacologic therapies that are being used or considered for treatment of coronavirus disease 2019 (COVID-19). There is a need for frequently updated practice guidelines on their use, based on critical evaluation of rapidly emerging literature. In March 2020, the Infectious Diseases Society of America (IDSA) formed a multidisciplinary guideline panel of infectious disease clinicians, pharmacists, and methodologists with varied areas of expertise. The process followed a rapid recommendation checklist. The panel prioritized questions and outcomes. Then a systematic review of the peer-reviewed and grey literature was conducted. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations. On April 11, 2020, IDSA released online initial treatment recommendations and narrative summaries of other treatments under evaluation. Since that time, the guideline panel and methodologists have continued to monitor the literature and issue updates and addendums to these guidelines in response to evolving research. Since the inception of its work, the panel has expressed the overarching goal that patients be recruited into ongoing trials, which would provide much needed evidence on the efficacy and safety of various therapies for COVID-19, given that we could not make a determination whether the benefits outweigh harms for most treatments."
Infectious Diseases Society of America
Bhimraj, Adarsh; Morgan, Rebecca L.; Shumaker, Amy Hirsch . . .
2020-09-04
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