Operational challenges and mitigation measures during the COVID-19 pandemic – lessons from DELIVER

Bhatt, A. S. et al. (2023) Operational challenges and mitigation measures during the COVID-19 pandemic – lessons from DELIVER. American Heart Journal, 263, pp. 133-140. (doi: 10.1016/j.ahj.2023.05.013) (PMID:37220822) (PMCID:PMC10200275)

Abstract

Background: Catastrophic disruptions in care delivery threaten the operational efficiency and potentially the validity of clinical research efforts, in particular randomized clinical trials. Most recently, the COVID-19 pandemic affected essentially all aspects of care delivery and clinical research conduct. While consensus statements and clinical guidance documents have detailed potential mitigation measures, few real-world experiences detailing clinical trial adaptations to the COVID-19 pandemic exist, particularly among, large, global registrational cardiovascular trials. Methods: We outline the operational impact of COVID-19 and resultant mitigation measures in the Dapagliflozin Evaluation to Improve the LIVEs of Patients with Preserved Ejection Fraction Heart Failure (DELIVER) trial, one of the largest and most globally diverse experiences with COVID-19 of any cardiovascular clinical trial to date. Specifically, we address the needed coordination between academic investigators, trial leadership, clinical sites, and the supporting sponsor to ensure the safety of participants and trial staff, to maintain the fidelity of trial operations, and to prospectively adapt statistical analyses plans to evaluate the impact of COVID-19 and the pandemic at large on trial participants. These discussions included key operational issues such as ensuring delivery of study medications, adaptations to study visits, enhanced COVID-19 related endpoint adjudication, and protocol and analytical plan revisions. Conclusion: Our findings may have important implications for establishing consensus on prospective contingency planning in future clinical trials. Clinicaltrial.gov: NCT03619213.

• Item Type: Articles
• Keywords: Mitigation, Coronavirus Disease 2019, trial operations.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Jhund, Professor Pardeep and McMurray, Professor John
• Authors: Bhatt, A. S., Lindholm, D., Nilsson, A., Zaozerska, N., Claggett, B. L., Vaduganathan, M., Kosiborod, M. N., Lam, C. S.P., Hernandez, A. F., Martinez, F. A., Inzucchi, S. E., Shah, S. J., de Boer, R. A., Desai, A., Jhund, P. S., Langkilde, A. M., Petersson, M., McMurray, J. J.V., and Solomon, S. D.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: American Heart Journal
• Publisher: Elsevier
• ISSN: 0002-8703
• ISSN (Online): 1097-6744
• Published Online: 21 May 2023
• Copyright Holders: Copyright © 2023 The Authors
• First Published: First published in American Heart Journal 263:133–140
• Publisher Policy: Reproduced under a Creative Commons License