ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic

Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) was initiated by the US government to rapidly develop and test vaccines and therapeutics against COVID-19 in 2020. The ACTIV Therapeutics-Clinical Working Group selected ACTIV trial teams and clinical networks to expeditiously develo...

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Bibliographic Details
Published in:Journal of clinical and translational science 2024, Vol.8 (1), p.e151, Article e151
Main Authors: Keshtkar-Jahromi, Maryam, Anstrom, Kevin J, Barkauskas, Christina, Brown, Samuel M, Daar, Eric S, Fischer, William, Gibbs, Kevin W, Higgs, Elizabeth S, Hughes, Michael D, Jagannathan, Prasanna, LaVange, Lisa, Lindsell, Christopher J, Nayak, Seema U, Paredes, Roger, Parmar, Mahesh, Peltan, Ithan D, Proschan, Michael, Shotwell, Matthew S, Vock, David M, Yokum, Tammy, Adam, Stacey J
Format: Article
Language:English
Subjects:
ACTIV
Antiviral drugs
clinical trial
Clinical trials
COVID-19
COVID-19 Therapeutic Platform Trials Lessons Learned
COVID-19 vaccines
design
Enrollments
Hospitalization
Hospitals
lessons
Mortality
Pandemics
Pathogenesis
Patient safety
Review
Severe acute respiratory syndrome coronavirus 2
Therapeutic targets
Thrombosis
Vaccines
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Summary:Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) was initiated by the US government to rapidly develop and test vaccines and therapeutics against COVID-19 in 2020. The ACTIV Therapeutics-Clinical Working Group selected ACTIV trial teams and clinical networks to expeditiously develop and launch master protocols based on therapeutic targets and patient populations. The suite of clinical trials was designed to collectively inform therapeutic care for COVID-19 outpatient, inpatient, and intensive care populations globally. In this report, we highlight challenges, strategies, and solutions around clinical protocol development and regulatory approval to document our experience and propose plans for future similar healthcare emergencies.
ISSN:2059-8661
2059-8661
DOI:10.1017/cts.2024.1