ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic

Maryam Keshtkar-Jahromi; Kevin J. Anstrom; Christina Barkauskas; Samuel M. Brown; Eric S. Daar; William Fischer; Kevin W. Gibbs; Elizabeth S. Higgs; Michael D. Hughes; Prasanna Jagannathan; Lisa Lavange; Christopher J. Lindsell; Seema U. Nayak; Roger Paredes; Mahesh Parmar; Ithan D. Peltan; Michael Proschan; Matthew S. Shotwell; David M. Vock; Tammy Yokum; Stacey J. Adam

doi:10.1017/cts.2024.1

ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic

Maryam Keshtkar-Jahromi, Kevin J. Anstrom, Christina Barkauskas, Samuel M. Brown, Eric S. Daar, William Fischer, Kevin W. Gibbs, Elizabeth S. Higgs, Michael D. Hughes, Prasanna Jagannathan, Lisa Lavange, Christopher J. Lindsell, Seema U. Nayak, Roger Paredes, Mahesh Parmar, Ithan D. Peltan, Michael Proschan, Matthew S. Shotwell, David M. Vock, Tammy YokumStacey J. Adam

Biostatistics

Research output: Contribution to journal › Review article › peer-review

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.

Original language	English (US)
Article number	e151
Journal	Journal of Clinical and Translational Science
Volume	8
Issue number	1
DOIs	https://doi.org/10.1017/cts.2024.1
State	Published - Oct 15 2024

Bibliographical note

Publisher Copyright:
© The Author(s), 2024. Published by Cambridge University Press on behalf of Association for Clinical and Translational Science.

Keywords

ACTIV
COVID-19
clinical trial
design
lessons

PubMed: MeSH publication types

Journal Article
Review

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10.1017/cts.2024.1

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Keshtkar-Jahromi, M., Anstrom, K. J., Barkauskas, C., Brown, S. M., Daar, E. S., Fischer, W., Gibbs, K. W., Higgs, E. S., Hughes, M. D., Jagannathan, P., Lavange, L., Lindsell, C. J., Nayak, S. U., Paredes, R., Parmar, M., Peltan, I. D., Proschan, M., Shotwell, M. S., Vock, D. M., ... Adam, S. J. (2024). ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic. Journal of Clinical and Translational Science, 8(1), Article e151. https://doi.org/10.1017/cts.2024.1

Keshtkar-Jahromi, M, Anstrom, KJ, Barkauskas, C, Brown, SM, Daar, ES, Fischer, W, Gibbs, KW, Higgs, ES, Hughes, MD, Jagannathan, P, Lavange, L, Lindsell, CJ, Nayak, SU, Paredes, R, Parmar, M, Peltan, ID, Proschan, M, Shotwell, MS, Vock, DM, Yokum, T & Adam, SJ 2024, 'ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic', Journal of Clinical and Translational Science, vol. 8, no. 1, e151. https://doi.org/10.1017/cts.2024.1

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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.",

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note = "Publisher Copyright: {\textcopyright} The Author(s), 2024. Published by Cambridge University Press on behalf of Association for Clinical and Translational Science.",

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AU - Daar, Eric S.

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AU - Gibbs, Kevin W.

AU - Higgs, Elizabeth S.

AU - Hughes, Michael D.

AU - Jagannathan, Prasanna

AU - Lavange, Lisa

AU - Lindsell, Christopher J.

AU - Nayak, Seema U.

AU - Paredes, Roger

AU - Parmar, Mahesh

AU - Peltan, Ithan D.

AU - Proschan, Michael

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AU - Vock, David M.

AU - Yokum, Tammy

AU - Adam, Stacey J.

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ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic

Abstract

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