Advanced Clinical Research and Clinical Trials

Although 85% of cancer patients in the United States are treated within the community-based setting, opportunities for advanced treatment options via clinical trials are lacking. The National Comprehensive Cancer Network (NCCN) Guidelines state “NCCN believes that the best management for any patient with cancer is a clinical trial. Participation in clinical trials is especially encouraged” (NCCN 2018). To address the need for clinical trials in the rural communities served by Sanford Health, efforts described here were employed over the last five years to develop and maintain a robust portfolio of clinical trials for physicians to utilize as innovative treatment options. Successful approaches to cultivating an oncology clinical research program include (but are not limited to): developing a relationship with clinical operations, administration, physicians, support staff, research staff, and external partners. Formal trial selection through a protocol review and monitoring committee ensures physician engagement in the process of building a trial portfolio, and assists the study team in identifying feasibility concerns at the outset of considering the trial at the site. Furthermore, leveraging efficiencies of an integrated health care system are critical for study-start up, data collection, and subject coordination – all of which contribute to a site’s ongoing ability to remain attractive for future site selection. In addition, utilizing existing infrastructure for patient care management to screen eligible patients for trial significantly increases institutional enrollment percentages. The complexities of a clinical trial program focused in oncology are wide and varied. However, building a program is not impossible as long as the appropriate commitment, strategy, and dedication of resources are applied.