Advancing Clinical Trials in Nursing Homes: A Proposed Roadmap to Success

• Published in: Journal of the American Geriatrics Society (JAGS) 2022-03, Vol.70 (3), p.701-708
• Main Authors: Gurwitz, Jerry H., Quinn, Charlene C., Abi‐Elias, Ivan H., Adams, Alyce S., Bartel, Rosie, Bonner, Alice, Boxer, Rebecca, Delude, Christopher, Gifford, David, Hanson, Bruce, Ito, Kouta, Jain, Paavani, Magaziner, Jay S., Mazor, Kathleen M., Mitchell, Susan L., Mody, Lona, Nace, David, Ouslander, Joseph, Reifsnyder, Jo Anne, Resnick, Barbara, Zimmerman, Sheryl
• Format: Article
• Language: English
• Subjects: Aged; Clinical trials; Clinical Trials as Topic - organization & administration; COVID-19; COVID-19 - epidemiology; Female; Health care; Humans; long‐term care; Male; Nursing homes; Nursing Homes - organization & administration; pandemic; Pandemics; Population studies; SARS-CoV-2; United States - epidemiology
• ISSN: 0002-8614; 1532-5415; 1532-5415
• DOI: 10.1111/jgs.17696

An effective clinical research effort in nursing homes to address prevention and treatment of COVID‐19 faced overwhelming challenges. Under the Health Care Systems Research Network‐Older Americans Independence Centers AGING Initiative, a multidisciplinary Stakeholder Advisory Panel was convened to develop recommendations to improve the capability of the clinical research enterprise in US nursing homes. The Panel considered the nursing home as a setting for clinical trials, reviewed the current state of clinical trials in nursing homes, and ultimately developed recommendations for the establishment of a nursing home clinical trials research network that would be centrally supported and administered. This report summarizes the Panel's recommendations, which were developed in alignment with the following core principles: build on available research infrastructure where appropriate; leverage existing productive partnerships of researchers with groups of nursing homes and nursing home corporations; encompass both efficacy and effectiveness clinical trials; be responsive to a broad range of stakeholders including nursing home residents and their care partners; be relevant to an expansive range of clinical and health care delivery research questions; be able to pivot as necessary to changing research priorities and circumstances; create a pathway for industry‐sponsored research as appropriate; invest in strategies to increase diversity in study populations and the research workforce; and foster the development of the next generation of nursing home researchers. See related editorial by Zimmerman et al. and Special Articles by Levy et al. and Resnick et al. in this issue.