TY - JOUR
T1 - ACTIV trials
T2 - Cross-trial lessons learned for master protocol implementation
AU - Keshtkar-Jahromi, Maryam
AU - Adam, Stacey J.
AU - Brar, Indira
AU - Chung, Lucy K.
AU - Currier, Judith S.
AU - Daar, Eric S.
AU - Davey, Victoria J.
AU - Denning, Eileen T.
AU - Gelijns, Annetine C.
AU - Higgs, Elizabeth S.
AU - Jagannathan, Prasanna
AU - Javan, Arzhang Cyrus
AU - Jensen, Tomas O.
AU - Jilg, Nikolaus
AU - Kalomenidis, Ioannis
AU - Kim, Peter
AU - Nayak, Seema U.
AU - Newell, Matthew
AU - Taiwo, Babafemi O.
AU - Yokum, Tammy
AU - Delph, Yvette
N1 - Publisher Copyright:
© National Institutes of Health, 2024.
PY - 2024/10/15
Y1 - 2024/10/15
N2 - 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.
AB - 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.
KW - Accelerating COVID-19 Treatment Interventions and Vaccines
KW - COVID-19
KW - clinical trial implementation
KW - master protocol
KW - preparedness
KW - trial platform
UR - https://www.scopus.com/pages/publications/85208240570
U2 - 10.1017/cts.2024.507
DO - 10.1017/cts.2024.507
M3 - Review article
AN - SCOPUS:85208240570
SN - 2059-8661
VL - 8
JO - Journal of Clinical and Translational Science
JF - Journal of Clinical and Translational Science
IS - 1
M1 - e152
ER -