Journal Article

ACTIV trials: cross-trial lessons learned for master protocol implementation

Denning, Eileen T., Javan, Arzhang Cyrus, Delph, Yvette, Adam, Stacey J., Currier, Judith S., Gelijns, Annetine C., Jagannathan, Prasanna, Jilg, Nikolaus, Higgs, Elizabeth S., Kim, Peter, Nayak, Seema U., Yokum, Tammy, Brar, Indira, Jensen, Tomas O., Kalomenidis, Ioannis, Newell, Matthew, Chung, Lucy K., Taiwo, Babafemi O., Keshtkar-Jahromi, Maryam, Daar, Eric S., Davey, Victoria J.

2024

Overview

The United States Government (USG) public-private partnership “Accelerating COVID-19 Treatment Interventions and Vaccines” (ACTIV) was launched to identify safe, effective therapeutics to treat patients with Coronavirus Disease 2019 (COVID-19) and prevent hospitalization, progression of disease, and death. Eleven original master protocols were developed by ACTIV, and thirty-seven therapeutic agents entered evaluation for treatment benefit. Challenges encountered during trial implementation led to innovations enabling initiation and enrollment of over 26,000 participants in the trials. While only two ACTIV trials continue to enroll, the recommendations here reflect information from all the trials as of May 2023. We review clinical trial implementation challenges and corresponding lessons learned to inform future therapeutic clinical trials implemented in response to a public health emergency and the conduct of complex clinical trials during “peacetime,” as well.

• Publisher: Cambridge University Press
• Subject: Accelerating COVID-19 Treatment Interventions and Vaccines / Antiviral drugs / clinical trial implementation / Clinical trials / Collaboration / Coronaviruses / COVID-19 / COVID-19 Therapeutic Platform Trials Lessons Learned / COVID-19 vaccines / Enrollments / master protocol / Medical innovations / Medical research / Monoclonal antibodies / Pandemics / Pharmaceutical industry / preparedness / Public health / R&D / Research & development / Review / trial platform