Clinical Protocol and Data Management

The Clinical Protocol and Data Management (CPDM) and the UNM Cancer Center Clinical Research Office (CRO) have undergone significant changes in the past year.

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Leadership Changes

In November 2017, George Atweh, MD, assumed the role of Interim Medical Director of the CPDM, replacing Olivier Rixe, MD, who continues to serve as Associate Director for Clinical Research. We anticipate that in the fall of 2018, Carolyn Muller, MD, will be named as the permanent Medical Director of CPDM, appropriately aligned with her role as principal investigator of the UNMCCC/NMCCA NCI NCORP Minority/Underserved Grant Program, supporting accrual of patients in our catchment area to NCI-sponsored clinical trials in the NCTN. At that time, Sarah Adams, MD, will assume the role of Chair of the Data Safety & Monitoring Committee.

 

George Atweh, MD

Carolyn Muller, MD, FACOG

Sarah Adams, MD

 

 

 

 

 

 

 

 

 

Changes and Accomplishments

Integrated Clinical Care and Research Delivery Model

The UNMCCC has developed a new Integrated Clinical Care and Research Delivery Model, integrating oncology physicians, clinical and research nurses, clinical trials support staff, nurse and patient navigators, schedulers, and medical assistants in disease-focused multidisciplinary clinics (such as Breast Cancers, Gastrointestinal Cancers, GYN Cancers, etc.). This model has had a significantly positive impact on clinical operations and improved screening of patients and accrual to clinical trials.

The overall goal was to improve the alignment of the clinical research and clinic staff, improving patient satisfaction and outcomes, and increasing the number of patients enrolled to clinical trials. The CRO staff are now organized into disease specific teams and work closely with the clinic partners to support cancer center faculty. This model, first successfully tested in Breast, GYN, and Phase I multidisciplinary clinics, is now being implemented center-wide.

Clinical Trials Process Improvement Project

Since October 2017, the UNMCCC has engaged the Cancer Service Line of the Huron Consulting Group (led by Beverly Ginsburg Cooper) to conduct a rigorous assessment and a process improvement project for the UNMCCC and NMCCA clinical trials organizations and network with the goal of modernizing the structure and operations of our CRO and the statewide network, enhancing training and education of CRO staff, and assuring best practices in regulatory, auditing, and compliance activities in light of increasing federal requirements. Terri Stewart, MS, MHA, Director of the UNMCCC Clinical Research Office and the NMCCA stepped down in May 2018. In the interim, Angela Allred of Huron is serving as the Interim Administrative Director of the CTO and NMCCA, supported by UNMCCC/NMCCA employees Leslie Byatt and Kaylee Deutsch. A national search for a new CRO and NMCCA Administrative Director will be opened in the fall of 2018.

Velos Upgrade

After consideration of a transition to the Oncor Clinical Trials Support System, UNMCCC and CPDM instead completed a full hardware and software upgrade of the Velos Web-based Clinical Trials Program.

2017 Accruals

In calendar year 2017, from an analytic case number of 2278 eligible patients treated at the UNMCCC (NCI Data Table 3), a total of 1307 patients were accrued to interventional studies. This is a significant increase in accrual from prior years.

Minority Accrual

The UNMCCC accrues women and minorities to clinical studies at rates that exceed their annual New Mexico cancer incidence. While New Mexico Hispanics comprise 48% of New Mexico’s population and account for only 30.6% of New Mexico cancer cases, they account for 29.2% of the therapeutic accruals at the UNMCCC. While American Indians account for 10.5% of New Mexico’s population and only 5.3% of New Mexico cancer cases, they account for 22.8% of the therapeutic and interventional accruals at the UNMCCC.

Phase I Program

Another major accomplishment was to build a new infrastructure for Early Phase Clinical Research, and a functional Phase I Unit in the UNM Cancer Treatment and Clinical Research Facility. Led by Rixe, this program and facility is now fully operational. Of the 2017 accruals, 33 were to the Phase I Program.

Data Safety Monitoring

The current UNMCCC Data Safety Monitoring Plan was approved by the NCI on March 15, 2017. There have been no major changes to the DSMP.

2018 Priorities

Quality Improvement Project to decrease clinical trial activation time. Through the CPDM Quality Assurance Committee, time to activation of new trial was identified as a major barrier. Dr. Dayao is the Leadership Project Sponsor working with the CPDM leadership to decrease the trial activation time.

Continue to implement the Velos Version 10 upgrades which include protocol calendars to be used for improving study compliance and research billing compliance, and an enhanced online real-time look-up of activated trials.