NIH to address dwindling clinical trial patient enrollment with centralized staffing support

What

A new initiative by the National Cancer Institute (NCI), part of the National Institutes of Health, aims to tackle the steep decline in participation in NCI-funded cancer clinical trials that is due in part to clinical trials staffing shortages that were exacerbated by the COVID-19 pandemic. These shortfalls have hampered clinical trials activities across the country, particularly in rural and underserved areas. 

Through the new NCI Virtual Clinical Trials Office, a centralized team of support staff—including research nurses, clinical research associates, and clinical data specialists—will work remotely to assist NCI-Designated Comprehensive Cancer Centers and community practices with their clinical trials activities. This assistance can include screening patients for eligibility, enrolling patients into trials, educating patients about research protocols, and performing data entry. 

The initiative will support clinical trials being conducted within several NCI clinical trials networks: NCI’s National Clinical Trials Network, the NCI Experimental Therapeutics Clinical Trials Network, and the NCI Community Oncology Research Program (NCORP). The idea for this centralized staffing support grew out of the successful Virtual Research Nurse Program that was launched by the Gulf South NCORP site in New Orleans to address the lack of trained research nurses.

Six cancer centers around the United States have been selected to participate in the initial phase of the pilot program. The initiative is being supported by NCI’s Division of Cancer Treatment and Diagnosis and the Division of Cancer Prevention with existing funds. The Frederick National Laboratory for Cancer Research, operated for NCI by Leidos Biomedical Research, Inc., is overseeing the effort, with Leidos Biomedical Research providing staff for the Virtual Clinical Trials Office that will support the clinical trials activities at the participating sites.

Who

Michael Montello, Pharm.D., M.B.A., Division of Cancer Treatment and Diagnosis, National Cancer Institute

About the National Cancer Institute (NCI): NCI leads the National Cancer Program and NIH’s efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website or call NCI’s contact center, the Cancer Information Service, at 1-800-4-CANCER (1-800-422-6237).

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit nih.gov