Journal of Clinical and Translational Science (Jan 2024)
ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic
- Maryam Keshtkar-Jahromi,
- Kevin J. Anstrom,
- Christina Barkauskas,
- Samuel M. Brown,
- Eric S. Daar,
- William Fischer,
- Kevin W. Gibbs,
- Elizabeth S. Higgs,
- Michael D. Hughes,
- Prasanna Jagannathan,
- Lisa LaVange,
- Christopher J. Lindsell,
- Seema U. Nayak,
- Roger Paredes,
- Mahesh Parmar,
- Ithan D. Peltan,
- Michael Proschan,
- Matthew S. Shotwell,
- David M. Vock,
- Tammy Yokum,
- Stacey J. Adam
Affiliations
- Maryam Keshtkar-Jahromi
- Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA
- Kevin J. Anstrom
- Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
- Christina Barkauskas
- Duke Clinical Research Institute, Duke University, Durham, NC, USA
- Samuel M. Brown
- Pulmonary and Critical Care Medicine, Intermountain, Salt Lake City, UT, USA
- Eric S. Daar
- Division of HIV Medicine, Lundquist Institute at Harbor- University of California Los Angeles Medical Center, Los Angeles, CA, USA
- William Fischer
- Division of Pulmonary Diseases and Critical Care Medicine, University of North Carolina at Chapel Hill, Salt Lake City, UT, USA
- Kevin W. Gibbs
- Wake Forest University School of Medicine, Winston-Salem, NC, USA
- Elizabeth S. Higgs
- Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA
- Michael D. Hughes
- Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA
- Prasanna Jagannathan
- Stanford University, Stanford, CA, USA
- Lisa LaVange
- Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
- Christopher J. Lindsell
- ORCiD
- Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA
- Seema U. Nayak
- Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA
- Roger Paredes
- Department of Infectious Diseases, Hospital Germans Trias and irsiCaixa, Badalona, Spain
- Mahesh Parmar
- Medical Research Council Clinical Trials Unit, University College of London, London, WC, UK
- Ithan D. Peltan
- Department of Pulmonary and Critical Care Medicine, Intermountain, Salt Lake City, UT, USA
- Michael Proschan
- National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA
- Matthew S. Shotwell
- Vanderbilt University, Nashville, USA
- David M. Vock
- Division of Biostatistics & Health Data Science, School of Public Health, University of Minnesota, Minneapolis, MN, USA
- Tammy Yokum
- National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA
- Stacey J. Adam
- ORCiD
- Foundation for the National Institutes of Health, North Bethesda, MD, USA
- DOI
- https://doi.org/10.1017/cts.2024.1
- Journal volume & issue
-
Vol. 8
Abstract
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.
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