Agile response to critical need for clinical trial accessibility during the first COVID-19 pandemic wave

Author:

Smith Stephanie,Millham Frederick

Abstract

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.    

Publisher

Weston Medical Publishing

Reference9 articles.

1. 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.

2. 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.

3. 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.

4. 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.

5. Office of Science and Technology Policy (OSTP): Request for Information; Clinical Research Infrastructure and Emergency Clinical Trials. Federal Register; 87 FR 64821; pages: 64821-

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