Clinical Protocol and Data Management

Funded in part as a Minority/Underserved NCI Community Oncology Research Program (NCORP; 2UG1CA189856-06; Muller, PI (CT)), Clinical Protocol and Data Management (CPDM) at the University of New Mexico Comprehensive Cancer Center (UNMCCC) is overseen by a centralized Clinical Research Office (CRO) for all cancer clinical research performed at UNMCCC and within our statewide 501c3 cancer clinical trials network with community health providers (The New Mexico Cancer Care Alliance; NMCCA).

The overarching goals of CPDM are to provide expert high quality central management to ensure all cancer clinical trials:

  1. are aligned with UNMCCC science;
  2. address cancer patterns and needs of the diverse New Mexico catchment area;
  3. are performed under the highest quality and rigor;
  4. meet federal and institutional regulations; and
  5. are monitored for performance, compliance and patient safety.

Clinical research at UNMCCC is led by Carolyn Muller, MD (Associate Director for Clinical Research (CT)) and Ursa Brown-Glaberman, MD (Medical Director of the CRO/CPDM (CT)).

In 2018, to assure operational improvement, efficiency, and increased compliance, the UNMCCC recognized the need to modernize and restructure the relationship between UNM and NMCCA. With assistance from Huron Consulting, a robust evaluation and process improvement project began, leading to a new collaborative model implemented in 2019-2020.

This model assures continued community participation by retaining the NMCCA 501c3, but moved and centralized all operations and staff (budgeting/contracting, trial activation, regulatory, quality assurance, auditing/ monitoring, training, and informatics) within the UNMCCC CRO/CPDM, now serving both UNMCCC and NMCCA. While necessitating a slowing of accruals in 2019-2020, the new structure is ensuring higher quality performance, increased CPDM oversight, greater community engagement and catchment area impact, and, is poised to achieve more robust accrual in the future.

In this grant period, within our catchment area’s population of 2.1 million people (63% racial/ethnic minorities, 40% insured by Medicaid, and 13.4% (age 18-64) uninsured), there were 7395 total accruals (2654 intervention and 4741 non-intervention). While COVID-19 severely impacted accruals in 2020, in 2019, CPDM supported the recruitment of 1361 accruals to 206 active clinical research protocols at UNMCCC (455 interventional and 906 non-interventional accruals) and 149 total accruals (135 interventional, and 14 non-interventional, 93% supporting NCORP) from NMCCA affiliate sites.

The CPDM performs robust auditing and data safety monitoring of investigator-initiated trials (IITs) across all sites engaged in UNM IITs under the 2020 updated DSMP. In 2019 and 2020 Q1-2 women represented 82% and 76% of interventional trial accruals respectively. Accruals of Hispanic (32%, 43%) and American Indian (10%, 9%) data across intervention trials align with the race and ethnic population of cancer patients in NM (2019, 2020). Intervention accruals span all ages with 28% > 65 years of age in 2019.