Re-engineering The Clinical Research Enterprise in Response to COVID-19: The Clinical Translational Science Award (CTSA) experience and proposed playbook for future pandemics
Open Access
- 18 February 2021
- journal article
- research article
- Published by Cambridge University Press (CUP) in Journal of Clinical and Translational Science
- Vol. 5 (1), 1-28
- https://doi.org/10.1017/cts.2021.10
Abstract
The 2020 COVID-19 pandemic has had a profound impact on the clinical research enterprises at the 60 Clinical and Translational Science Award (CTSA) Hubs throughout the nation. There was simultaneously a need to expand research to obtain crucial data about disease prognosis and therapy and enormous limitations on conducting research as localities and institutions limited travel and person-to-person contact. These imperatives resulted in major changes in the way research was conducted, including expediting Institutional Review Board review, shifting to remote interactions with participants, centralizing decision-making in prioritizing research protocols, establishing biobanks, adopting novel informatics platforms, and distributing study drugs in unconventional ways. National CTSA Steering Committee meetings provided an opportunity to share best practices and develop the idea of capturing the CTSA program experiences in a series of papers. Here we bring together the recommendations from those papers in a list of specific actions that research sites can take to strengthen operations and prepare for similar future public health emergencies. Most importantly, creative innovations developed in response to the COVID-19 pandemic deserve serious consideration for adoption as new standards, thus converting the painful trauma of the pandemic into "post-traumatic growth" that makes the clinical research enterprise stronger, more resilient, and more effective.Keywords
This publication has 13 references indexed in Scilit:
- Coronavirus Disease 2019–COVID-19Clinical Microbiology Reviews, 2020
- Rereading Arrowsmith in the COVID-19 PandemicJAMA, 2020
- Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscapeBiosensors and Bioelectronics, 2020
- Asymptomatic carriers of COVID-19 as a concern for disease prevention and control: more testing, more follow-upBioScience Trends, 2020
- Immediate impact of the COVID-19 pandemic on CTSA TL1 and KL2 training and career developmentJournal of Clinical and Translational Science, 2020
- First cases of coronavirus disease 2019 (COVID-19) in the WHO European Region, 24 January to 21 February 2020Eurosurveillance, 2020
- A novel coronavirus outbreak of global health concernThe Lancet, 2020
- Clinical features of patients infected with 2019 novel coronavirus in Wuhan, ChinaThe Lancet, 2020
- Decoding the evolution and transmissions of the novel pneumonia coronavirus (SARS-CoV-2 / HCoV-19) using whole genomic dataZoological Research, 2020