ACTIV trials : Lessons learned in trial design in the setting of an emergent pandemic
Keshtkar-Jahromi, M. (National Institutes of Health (Bethesda, Estats Units d'Amèrica))
Anstrom, K.J. (University of North Carolina at Chapel Hill)
Barkauskas, C. (Duke University)
Brown, S.M. (Pulmonary and Critical Care Medicine. Intermountain)
Daar, E.S. (University of California Los Angeles Medical Center)
Fischer, W. (University of North Carolina at Chapel Hill)
Gibbs, K.W. (Wake Forest University)
Higgs, E.S. (National Institutes of Health (Bethesda, Estats Units d'Amèrica))
Hughes, M.D. (Harvard T.H. Chan School of Public Health (Boston, Estats Units d'Amèrica))
Jagannathan, P. (Stanford University)
Lavange, L. (University of North Carolina at Chapel Hill)
Lindsell, C.J. (Duke University)
Nayak, S.U. (National Institutes of Health (Bethesda, Estats Units d'Amèrica))
Paredes, Roger (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Parmar, M. (University College of London)
Peltan, I.D. (Intermountain (Salt Lake Ctiy, Estats Units d'Amèrica). Department of Pulmonary and Critical Care Medicine)
Proschan, M. (National Institute of Allergy and Infectious Diseases (Bethesda, Estats Units d'Amèrica))
Shotwell, M.S. (Vanderbilt University)
Vock, D.M. (University of Minnesota)
Yokum, T. (National Institute of Allergy and Infectious Diseases (Bethesda, Estats Units d'Amèrica))
Adam, S.J. (Foundation for the National Institutes of Health)
Universitat Autònoma de Barcelona

Date:	2024
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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article de revisió ; recerca ; Versió publicada
Subject:	ACTIV ; COVID-19 ; Clinical trial ; Design ; Lessons
Published in:	Journal of Clinical and Translational Science, Vol. 8 Núm. 1 (15 2024) , p. e151, ISSN 2059-8661

DOI: 10.1017/cts.2024.1
PMID: 39478775

10 p, 1.3 MB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Articles > Research articles
Articles > Published articles