Mitigating the Impact of COVID-19 on Funded Clinical Research: Crucial Next Steps
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Division of General Internal Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA; 2Center for Advancing Population Science, Medical College of Wisconsin, Milwaukee, WI, USA; 3Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, WI, USA; 4 Center for Innovation to Implementation (Ci2i), Veteran Affairs Palo Alto Health Care System, Palo Alto, CA, USA; 5Division of Primary Care and Population Health, Stanford University, Stanford, CA, USA.
J Gen Intern Med DOI: 10.1007/s11606-020-06342-8 © Society of General Internal Medicine 2020
PERSPECTIVE
The COVID-19 pandemic is a catastrophic event that has resulted in unprecedented disruption of clinical research and could have grave long-term consequences on the integrity and rigor of funded research. Clinical research improves lives and has a significant impact on economic productivity, and advancement of science, worldwide. 1,2 Scientific progress relies on systematic and continuous funding of innovative and transformative ideas, and requires dedication to funding both edge science (the regular exercise of trying out new ideas) and high impact science.3,4 The initial phase of the COVID-19 pandemic shutdown much of clinical research through quarantines, site closures, social distancing restrictions, travel limitations, interruptions in the supply chain, and increased risk to both personnel and study participants.5 Recovery and reopening has been slow due to a shortage of consistent access to personal protective equipment (PPE), limits on the size of gatherings impacting recruitment and consent procedures, the need for staff to quarantine after suspected exposure due to limited rapid test options, and impacts on transportation and stability of many research participants. Though some flexibilities in federal clinical research spending were provided through the end of September 20206–8, the resurgence of COVID-19 in many regions and difficulties in restarting research, particularly randomized controlled trials, make it unlikely that the majority of clinical research will meet pre-COVID milestones and deadlines for recruitment. In addition, many funding agencies and research institutions are focused on prioritizing COVID-19 research studies, although the public health challenges and clinical problems that existed before COVID-19 are still very relevant. Important research questions on chronic disease, cancer, drug development, and aging, for example, will remain even after a vaccine is Received August 3, 2020 Accepted October 31, 2020
developed for COVID-19. Therefore, it is necessary to protect non-COVID-19 focused clinical research. There are four primary challenges facing ongoing nonCOVID-19-related research that will require flexibility in approach, timelines, and targets to ensure research integrity. First, disruption of research studies and changes in safe procedures for recruiting and monitoring participants will require accommodations by research teams. Second, research participants now face additional challenges and consider
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