Clinical Protocol and Data Management

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CPDM Leadership Changes

Carolyn Muller, MD, FACOG

Carolyn Muller, MD, FACOG

In November 2018, Carolyn Muller, MD, assumed the role of Interim Medical Director of the CPDM, replacing George Atweh, MD. Carolyn Muller, MD also serves as Associate Director for Clinical Research as these roles appropriately aligned with her role as PI 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, Leslie Andritsos, MD, will assume the role of Chair of the Data Safety & Monitoring Committee with Zoneddy Dayao, MD serving as the Vice-Chair.

Changes and Accomplishments

Significant changes have occurred in the CPDM and the UNMCCC Clinical Research Office (CRO) in this project period.

  1. 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.
  2. 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, Director of the UNMCCC Clinical Research Office (CRO) and the Center’s statewide clinical trials network (NMCCA) stepped down in May 2018. In the interim, Amy Overby is serving as the Interim Administrative Director of the CRO and NMCCA, supported by UNMCCC/NMCCA employees Leslie Byatt and Kaylee Deutsch. A national search for a new CRO and NMCCA Administrative Director is currently ongoing.
  3. A Regulatory Activation Specialist was hired to monitor and track protocols during the start-up process. This position was created to enhance transparency and communication during the study initiation phase and to reduce time-to activation
  4. A new multidisciplinary Operational Feasibility Committee charged with conducting operational reviews of clinical trials was developed. In an effort to improve time to activation and assist the CWGs in assessing operational feasibility, this committee reviews the adequacy of financial resources and staffing and identifies operational issues that may preclude studies from being activated and timely completed
  5. The CRO completed a detailed, thorough review of current Standard Operating Procedures (SOPs) which lead to an updated and expanded SOP library.
  6. A comprehensive improved rigorous staff training and education program was implemented for UNMCCC and NMCCA staff to enhance recruitment, retention, staff performance, and PI satisfaction. The program includes an enhanced onboarding program, plan for continuing education and maintenance and staff development, a training program on the revised policies and procedures and best practices.
  7. Velos Upgrade. Updated Velos data management software (Dec 2017) and support team to better interface across all trial enrollments from UNMCCC and NMCCA focusing on cross checks between NCORP SYS, CTRP and other NCI based systems.
  8. 2018 Accruals. In calendar year 2018, from an analytic case number of 1978 eligible patients treated at the UNMCCC (NCI Data Table 3). In 2018 alone, the CRO reported the recruitment of 1610 individuals into all clinical research studies being conducted within the UNMCCC and NMCCA (696 interventional and 914 non-interventional accruals) and has facilitated the activation of more than 246 studies, including 59 institutional and externally peer-reviewed studies. The CRO also provides support to the NMCCA with a priority for NCTN/Research base enrollment in support of our institutions Minority-Underserved NCORP. The NMCCA enrolled 131 accruals to interventional trials of which 107 supported the mission of the MU-NCORP grant to bring trial access to our catchment populations.
  9. Minority Accrual. The population distribution between men and women in the state of New Mexico is 46% male and 54% These statistics are comparable to the national distribution of cancer incidence rates between males and females as well as what is seen within the clinical setting. In 2018, females represented 71% of UNMCCC’s interventional treatment of individuals, 43% of non-treatment interventional and non-interventional accruals, while 61% of UNMCCC’s new patients were female and 46% of new cancer diagnoses in New Mexico were female. While New Mexico Hispanics comprise of 48% of New Mexico’s population, they account for only 49% of New Mexico cancer cases. Matching this cancer incidence, Hispanics accounted for 38% of the therapeutic individuals at the UNMCCC. While NM American Indians account for 11% of New Mexico’s population, they account for only 6% of New Mexico cancer cases. Yet, 3% of the therapeutic interventional and 7% of the total interventional/non-interventional individuals at the UNMCCC were American Indians.
  10. Inclusion of Children in Research. The UNMCCC supports the NIH policy on the inclusion of children in research. UNMCCC is an active member of the NCTN Children’s Oncology Group and is working to expand the COG membership to our Presbyterian health Systems NMCCA affiliate within this next grant cycle as COG allows. In 2018, 8 children (17% of newly registered children) were enrolled onto interventional studies and 40 children (83%) were enrolled to non-interventional trials.
  11. 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.
  12. 2018 Priorities: 1).To monitor patterns of cancer incidence, mortality and disparity in the multiethnic, urban and rural populations of New Mexico and assure that our clinical research program delivers screening, prevention and therapeutic clinical trials and interventions that address the cancer care needs of our catchment area. 2). To provide a clinical research infrastructure that promotes timely activation, accrual and high quality execution of clinical trials and interventional studies. 3). To leverage the expertise and discovery science of our cancer Center to develop innovative screening, prevention, biomarker and early phase therapeutic trials. 4). To translate our expertise in addressing barriers to clinical trial participation and employing unique models for cancer care delivery (Project ECHO, statewide networks) in minority, underserved and rural populations to the NCTN/NCORP programs. 5). To educate and train staff and early stage clinical investigators in the process of clinical trial design, execution, compliance and regulatory requirements