ACTIV trials: cross-trial lessons learned for master protocol implementation
Recommended Citation
Keshtkar-Jahromi M, Adam SJ, Brar I, Chung LK, Currier JS, Daar ES, Davey VJ, Denning ET, Gelijns AC, Higgs ES, Jagannathan P, Javan AC, Jensen TO, Jilg N, Kalomenidis I, Kim P, Nayak SU, Newell M, Taiwo BO, Yokum T, and Delph Y. ACTIV trials: cross-trial lessons learned for master protocol implementation. J Clin Transl Sci 2024; 8(1):e152.
Document Type
Article
Publication Date
10-15-2024
Publication Title
J Clin Transl Sci
Abstract
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.
PubMed ID
39540114
Volume
8
Issue
1
First Page
152
Last Page
152
