Article ; Online: Resilient Clinical Trial Infrastructure in Response to the COVID-19 Pandemic: Lessons Learned from the TOGETHER Randomized Platform Clinical Trial.
The American journal of tropical medicine and hygiene
2022 Volume 106, Issue 2, Page(s) 389–393
Abstract: In response to the COVID-19 pandemic, clinical research groups across the world developed trial protocols to evaluate the safety and efficacy of treatments for COVID-19. Despite this initial enthusiasm, only a small portion of these protocols were ... ...
| Abstract | In response to the COVID-19 pandemic, clinical research groups across the world developed trial protocols to evaluate the safety and efficacy of treatments for COVID-19. Despite this initial enthusiasm, only a small portion of these protocols were implemented. Of those implemented, a fraction successfully recruited their target sample size to analyze and disseminate findings. More than a year and a half into the COVID-19 pandemic, only a few clinical trials evaluating treatments for COVID-19 have generated new evidence. Productive randomized platform clinical trials evaluating COVID-19 treatments may attribute their success to intentional investments in developing resilient clinical trial infrastructures. Health system resiliency discourse provides a conceptual framework for characterizing attributes for withstanding shocks. This framework may also be useful for contextualizing the attributes of productive clinical trials evaluating COVID-19 therapies. We characterize the successful attributes and lessons learned in developing the TOGETHER Trial infrastructure using a health system resiliency framework. This framework may be considered by clinical trialists aiming to build resilient trial infrastructures capable of responding rapidly and efficiently to global health threats. |
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| MeSH term(s) | COVID-19/drug therapy ; COVID-19/therapy ; Delivery of Health Care/organization & administration ; Efficiency, Organizational ; Humans ; Randomized Controlled Trials as Topic ; Research Design ; SARS-CoV-2 |
| Language | English |
| Publishing date | 2022-01-07 |
| Publishing country | United States |
| Document type | Journal Article |
| ZDB-ID | 2942-7 |
| ISSN | 1476-1645 ; 0002-9637 |
| ISSN (online) | 1476-1645 |
| ISSN | 0002-9637 |
| DOI | 10.4269/ajtmh.21-1202 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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