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


  • Stephanie Smith, PhD
  • Frederick Millham, MD, MBA



coronavirus disease 2019, clinical trial infrastructure, emergency preparedness, human research protections, institutional response, pandemic


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.



Author Biographies

Stephanie Smith, PhD

South Shore Hospital, Weymouth; Boston University School of Medicine, Boston, Massachusetts

Frederick Millham, MD, MBA

South Shore Hospital, Weymouth, Massachusetts


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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.

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; 2022-23110. Available at Accessed December 14, 2022.

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Food and Drug Administration (FDA): Expanded Access. 2023. Available at Accessed March 14, 2023.



How to Cite

Smith, S., and F. Millham. “Agile Response to Critical Need for Clinical Trial Accessibility During the First COVID-19 Pandemic Wave”. American Journal of Disaster Medicine, vol. 19, no. 1, Feb. 2024, pp. 79-82, doi:10.5055/ajdm.0465.



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