The widespread social and economic disruption caused by the novel coronavirus (COVID-19) directly impacts the tens of thousands of existing clinical trial participants in the United States. This paper reviews obvious and potential challenges faced by various stakeholders in biomedical research as public and private organizations that had trials underway before the pandemic’s onset grapple with the situation.
The imminent challenges faced by research participants in intervention clinical studies include concerns for adequate access to and availability of experimental therapeutic agents that are not available outside regulated clinical trials, travel arrangements to be made if the clinical trial site is distant, existence of adequate expertise closer to the patients to deal with side effects or challenges that may arise in the context of clinical trials and impact this may have on the caregivers.
Some of the options available for investigators and study teams are to consider minimizing face-to-face visits, when possible, and develop plans with the sponsors for alternatives such as telephone visit, telemedicine visit utilizing the technological expertise available at various sites. The teams should proactively contact research patients and discuss their concerns and contingency plans. The sponsors should consider conducting pre-site visits, site-initiation visits and routine monitoring visits remotely utilizing current advancements in remote video and tele-communications as several HIPAA compliant options are in existence.
Sher T, Wright RS, Public Health Crises and the Human Subjects of Biomedical Research: A Focus on COVID-19, Mayo Clinic Proceedings (2020), 13 April 2020. doi:https://doi.org/10.1016/j.mayocp.2020.04.016
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