Preparing better: Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) therapeutics trials lessons learned: A call to the future

Stacey J Adam; Timothy G Buchman; Judith S Currier; Ruxandra Draghia-Akli; Josh P Fessel; Elizabeth S Higgs; Eric A Hughes; Lisa LaVange; Joseph P Menetski; Sarah W Read; Yves Rosenberg; Randall Tressler; ACTIV Therapeutics-Clinical Working Group

doi:10.1017/cts.2024.178

Preparing better: Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) therapeutics trials lessons learned: A call to the future

J Clin Transl Sci. 2024 Oct 15;8(1):e150. doi: 10.1017/cts.2024.178. eCollection 2024.

Affiliations

¹ Foundation for the National Institutes of Health, North Bethesda, MD, USA.
² Critical Care Center, Emory University School of Medicine, Atlanta, GA, USA.
³ Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
⁴ The Janssen Pharmaceutical Companies of Johnson & Johnson, Titusville, NJ, USA.
⁵ National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD, USA.
⁶ National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA.
⁷ Teva Pharmaceuticals, Parsippany, NJ, USA.
⁸ Biostatistics, Gillings School of Global Public Health at the University of North Carolina at Chapel Hill, NC, USA.
⁹ National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.

Abstract

The Accelerating COVID-19 Therapeutic Interventions and Vaccines Therapeutic-Clinical Working Group members gathered critical recommendations in follow-up to lessons learned manuscripts released earlier in the COVID-19 pandemic. Lessons around agent prioritization, preclinical therapeutics testing, master protocol design and implementation, drug manufacturing and supply, data sharing, and public-private partnership value are shared to inform responses to future pandemics.

Keywords: Covid-19; lessons learned; master protocol; therapeutics; trials.

Publication types

Review