COVID-19 and geriatric clinical trials research
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COVID‑19 and geriatric clinical trials research Elizabeth K. Rhodus1 · Shoshana H. Bardach1,2 · Erin L. Abner1,3 · Allison Gibson1,4 · Gregory A. Jicha1,5,6 Received: 4 June 2020 / Accepted: 31 August 2020 © Springer Nature Switzerland AG 2020
Keywords COVID-19 · Research · Clinical Trails
Introduction The SARS-CoV-2 pandemic has wrought tremendous upheaval to daily life, spreading rapidly and causing millions to contract COVID-19. The long-term effects are yet unknown, but scientists are studying the disease and searching for solutions. In geriatric clinical trials research, the problems presented by COVID-19 are multifaceted: older adults face increased risk of morbidity and mortality due to COVID-19, and so ongoing clinical trials that enroll geriatric participants have been disrupted, appropriately so, in light of these increased risks [1]. Yet, the interruption of ongoing trials may further increase risks to older adults as critical research on treatments for highly prevalent diseases and conditions is slowed or stopped. Further, older adults are substantially underrepresented in clinical trials research, and this situation may worsen this discrepancy. Scientists in aging appreciate the necessity of older adults’ inclusion within clinical trials, but the vulnerability to increased exclusion in clinical trials of this population is high, now more than ever. Attention to clinical trial development with special attention to need for inclusion of older * Elizabeth K. Rhodus [email protected] 1
Sanders‑Brown Center on Aging, University of Kentucky, Lexington, KY 40536, USA
2
Graduate Center for Gerontology, University of Kentucky, Lexington, KY 40536, USA
3
Department of Epidemiology, University of Kentucky, Lexington, KY 40536, USA
4
College of Social Work, University of Kentucky, Lexington, KY 40536, USA
5
Department of Behavioral Science, University of Kentucky, Lexington, KY 40536, USA
6
Department of Neurology, University of Kentucky, Lexington, KY 40536, USA
adults and precautions is greatly needed to sustain current efforts, at minimum, and ideally, enhance recognition of the value of including older adults in clinical trial research. The COVID-19 crisis affects every aspect of clinical trial research engagement including: recruitment and retention; ability to ensure participant safety while engaged in experimental interventions; study procedures, including consideration of remote assessments, impact on populations with health disparities, and generalizability of future results; outcome measures, including biomarker assessment; impact on the clinical trial workforce, including attrition; impact on dissemination of results and scientific collaborations, which move the clinical trial infrastructure forward; current and future funding allocations; and regulatory considerations in regards to management of altered study conduct and change of outcome measures (Fig. 1). The purpose of this article is to highlight the impact of disasters such as the COVID-19 pandemic o
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