A Mount Sinai Steering Committee Helps Merge Clinical Trials Into the SOC in Oncology

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The establishment of a clinical trial steering committee by the Mount Sinai Health System was proven feasible and effective in improving the integration of therapeutic clinical trials into the standard of care (SOC) for patients with cancer, according to findings from a single-center experience that were presented at the 50th Annual Oncology Nursing Society Congress.

“The Mount Sinai Health System clinical trial steering committee was established with the primary goal of defining two levels of staff participation. Level 1 [comprised] foundational awareness of the importance of clinical trials and level 2 [consisted of the] integration of appropriate aspects of therapeutic clinical trials into the SOC and alignment of staffing models,” Frances Cartwright, PhD, RN, AOCN, vice president of Nursing, Mount Sinai Health System Oncology Services, and associate professor, Department of Medicine, Icahn School of Medicine at Mount Sinai in New York, New York, and coauthors wrote in the poster presentation.

The Mount Sinai Health System is known for providing optimal patient care informed by the results of randomized therapeutic clinical trials. As a global leader in patient care, Mount Sinai understands that nurses are critical to the successful adoption of research into best-practice clinical care. As such, a nurse-led, interdisciplinary approach was suggested as a way of improving the integration of therapeutic clinical trials into SOC to achieve optimal patient-centric, best-practice workflows and high reliability.

In addition to facilitating improved patient care, the program was designed to increase awareness among nurses and interdisciplinary teams regarding the importance of patient participation in therapeutic clinical trials; improve critical thinking across all nursing and interdisciplinary teams regarding randomized therapeutic clinical trials; ensure that integrating randomized therapeutic clinical trials into clinical practice promotes patient safety, encourages confident decision-making, minimizes duplicated efforts, and improves overall quality of care; and foster collaboration between clinical and research staff, leading to better use of resources, care coordination, and enrollment processes.

To bring the program to life, once levels 1 and 2 of staff participation were clearly delineated, the committee worked to standardize education and competencies for both levels of participation; establish a system-wide policy and procedure; identify pilot sites to test to feasibility of scaling the program across the system; track and identify outcomes; and share the results system-wide.

As part of the poster presentation, the coauthors shared the parameters for how the success of the program was measured. To date, the “Foundations for Success” PEAK module for level 1 education and training has been reviewed, approved, and launched as of August 2024. “This training will be mandatory for all Mount Sinai Health System new orientees and will be required annually, effective December 2024,” the authors detailed.

Additionally, the level 2 template has been reviewed and approved, having aligned with practice and inpatient settings during the pilot go-live phase. Finally, the Mount Sinai Health System ON212 clinical trials service requirements and processes were updated and approved on August 1, 2024, to include all sites across the 7-hospital–wide system. The document encapsulates the education, competency, and procedures for integrating level 1 and level 1 therapeutic clinical trials into the SOC.

Disclosures: Cartwright did not list any disclosures.

Reference

Cartwright F, Pouliot J, Middlekauff S, et al. A team-based approach to the integration of therapeutic clinical trials into oncology standard of care. Presented at: 50th Annual Oncology Nursing Society Congress; April 9-April 13, 2025; Denver, CO. Abstract RS15.