Keshtkar-Jahromi, Maryam;
Anstrom, Kevin J;
Barkauskas, Christina;
Brown, Samuel M;
Daar, Eric S;
Fischer, William;
Gibbs, Kevin W;
... Adam, Stacey J; + view all
(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. 10.1017/cts.2024.1.
Preview |
Text
Parmar_activ-trials-lessons-learned-in-trial-design-in-the-setting-of-an-emergent-pandemic.pdf Download (1MB) | Preview |
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.
| Type: | Article |
|---|---|
| Title: | ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1017/cts.2024.1 |
| Publisher version: | http://dx.doi.org/10.1017/cts.2024.1 |
| Language: | English |
| Additional information: | This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited. |
| Keywords: | ACTIV, COVID-19, clinical trial, design, lessons, RESPIRATORY-DISTRESS-SYNDROME |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10199458 |
Archive Staff Only
 |
View Item |
