The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory

Trials

Jeremy Sugarman¹  Patrick J. Heagerty²  Lesley H. Curtis³  Emily C. O’Brien³  Kevin P. Weinfurt³  Adrian F. Hernandez⁴  Eric B. Larson⁵ 

[1] Berman Institute of Bioethics, Johns Hopkins University;Department of Biostatistics, University of Washington;Department of Population Health Sciences, School of Medicine, Duke University;Duke Clinical Research Institute, School of Medicine, Duke University;Kaiser Permanente Washington Health Research Institute;

关键词: Pragmatic clinical trials;    Research participation;    COVID-19;   

DOI  :  10.1186/s13063-022-06385-8

来源: DOAJ

【 摘 要 】

Abstract Background The COVID-19 pandemic has considerably disrupted nearly all aspects of daily life, including healthcare delivery and clinical research. Because pragmatic clinical trials are often embedded within healthcare delivery systems, they may be at high risk of disruption due to the dual impacts on the conduct of both care and research. Methods We collected qualitative data using multiple methods to characterize the impact of COVID-19 on the research activities of 14 active pragmatic clinical trials in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. A COVID-19 impact questionnaire was administered electronically to principal investigators in June 2020. Text responses were analyzed thematically, and qualitative summaries were subsequently reviewed by five independent reviewers, who made iterative revisions. Additional COVID-19-related impacts were identified during virtual meetings with trial teams during April–July 2020 and combined with questionnaire responses for analysis. Results Impacts of the pandemic were broadly classified into two main types: healthcare operations and social distancing. In some instances, trial delays created statistical challenges, particularly with trials using stepped-wedge designs, and necessitated changing data collection strategies or modifying interventions. The majority of projects used existing stakeholder-driven approaches to adapt interventions. Several benefits of these adaptions were identified, including expanded outreach capabilities and ability to study virtual intervention delivery. All trial teams were able to adapt to pandemic-related modifications. Conclusion In a group of 14 ongoing pragmatic clinical trials, there was significant impact of COVID-19 on trial activities. Engaging appropriate stakeholders was critical to designing and implementing trial modifications and making continued safe progress toward meeting research objectives.

【 授权许可】

Unknown