Lessons learned from the conduct of inpatient clinical trials in a pandemic

O’Halloran et al., Journal of Clinical and Translational Science, doi:10.1017/cts.2024.483

Oct 2024

Review of challenges and potential solutions for conducting inpatient clinical trials during the pandemic, based on issues with the ACTIV trials. Challenges include competing clinical trials, interplay between clinical care and research conduct, infection control considerations, arduous consenting procedures, onerous trial procedures, and recruitment issues.

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O’Halloran et al., 15 Oct 2024, peer-reviewed, 11 authors. Contact: janeaohalloran@wustl.edu.

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Lessons learned from the conduct of inpatient clinical trials in a pandemic

Jane A O’halloran, Jeremy R Beitler, Lucy K Chung, Mamta K Jain, Akram Khan, Lisa H Merck, Ahmad Mourad, Minn A Oh, Shweta Sharma, Tammy Yokum, Seema U Nayak

Journal of Clinical and Translational Science, doi:10.1017/cts.2024.483

Background: The COVID-19 pandemic amplified known challenges associated with the conduct of inpatient clinical trials, while also introducing new ones that needed to be addressed. Methods: Stakeholders based in the United States who participated in the conduct of inpatient therapeutic trials for the treatment of COVID-19 as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines program identified challenges experienced in the conduct of these trials through a series of meeting to discuss and identify common themes. In addition, innovations developed to address these challenges and other potential solutions that may be utilized in future pandemics were highlighted. Results: Six thematic challenges including infection control considerations, the interplay between provision of clinical care and research, competing clinical trials, arduous consenting procedures, onerous procedural requirements, and participant recruitment including achieving representation of diverse populations were identified and are discussed here. Conclusions: Consideration of the lessons learned and recommendation outlined here may allow for more efficient conduct of inpatient clinical trials in future pandemics.

Author contributions. JAO, JRB, LKC, MKJ, AK, LHM, AM, MAO, SS, TY, and SUN all contributed to the conception of the article, collection of the lessons learned, interpretation of the information collected, and drafting and revising of the article. All authors were involved in the conduct of one or more ACTIV master protocol studies (ACTIV-1, -2, -3. -4. -5, or -6), which is where they drew the lessons learned collected. JAO takes responsibility for the article and will act as corresponding author. Funding statement. The authors did not receive funding support for the submitted work. The ACTIV clinical trials referenced in this article received funding from various United States Government funding agencies. Competing interests. Dr. Beitler reports prior consulting fees from Sedana Medical, Global Blood Therapeutics, Biomarck, and Arrowhead for work on advisory committees unrelated to this manuscript, funds from Sedana Medical paid to Columbia University for work as principal investigator of a clinical trial unrelated to this manuscript, and fees from Hamilton Medical for work as medical monitor of a clinical trial unrelated to this manuscript.

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