Agile response to critical need for clinical trial accessibility during the first COVID-19 pandemic wave
DOI:
https://doi.org/10.5055/ajdm.0465Keywords:
coronavirus disease 2019, clinical trial infrastructure, emergency preparedness, human research protections, institutional response, pandemicAbstract
This article discusses some of the major challenges that the clinical research community faced during the early days of the coronavirus disease 2019 pandemic. A model is offered that may assist other institutions while planning for future pandemics or disasters.
References
Shi J, Xiao Y, Zhang Y, et al.: Challenges of drug development during the COVID-19 pandemic: Key considerations for clinical trial designs. Br J Clin Pharma. 2021; 87(5): 2170-2185. DOI: https://doi.org/10.1111/bcp.14629
Bhatt A: Clinical trials during the COVID-19 pandemic: Challenges of putting scientific and ethical principles into practice. Perspect Clin Res. 2020; 11(2): 59-63. DOI: 10.4103/picr.PICR_77_20. DOI: https://doi.org/10.4103/picr.PICR_77_20
Meyer RD, Ratitch B, Wolbers M, et al.: Statistical issues and recommendations for clinical trials conducted during the COVID-19 pandemic. Stat Biopharm Res. 2020; 12(4): 399-411. DOI: 10.1080/19466315.2020.1779122. DOI: https://doi.org/10.1080/19466315.2020.1779122
The White House: National Biodefense Strategy (NBS) and Implementation Plan for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security (revised 2022). Available at https://www.whitehouse.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf. Accessed March 14, 2023.
Office of Science and Technology Policy (OSTP): Request for Information; Clinical Research Infrastructure and Emergency Clinical Trials. Federal Register; 87 FR 64821; pages: 64821-
; 2022-23110. Available at https://www.federalregister.gov/documents/2022/10/26/2022-23110/request-for-information-clinicalresearch-infrastructure-and-emergency-clinical-trials. Accessed December 14, 2022.
The White House: Preparing US clinical trials infrastructure for emergencies: A white house virtual roundtable discussion. Available at https://www.whitehouse.gov/ostp/news-updates/2023/01/06/preparing-u-s-clinical-trials-infrastructure-for-emergencies-a-whitehouse-virtual-roundtable-discussion/. Accessed March 14, 2023.
Gilead Sciences: Study to evaluate the efficacy and safety of Remdesivir (GS-5734™) treatment of coronavirus disease 2019 (COVID-19) in an outpatient setting. NCT# NCT04501952 (posted 2020). Available at ClinicalTrials.gov. Accessed March 14, 2023.
Food and Drug Administration (FDA): Expanded Access. 2023. Available at https://www.fda.gov/news-events/public-health-focus/expanded-access. Accessed March 14, 2023.
Published
How to Cite
Issue
Section
License
Copyright 2007-2023, Weston Medical Publishing, LLC
All Rights Reserved
