The MBRCC Clinical Trials Shared Resource, also referred to as the Clinical Trials Research Unit (CTRU) core facility is dedicated to providing services and expertise to the faculty and staff of the WVU HSC to support the clinical research enterprise.
The mission of the MBRCC is to develop and support a highly collaborative and translational clinical trials research program. The goal is to provide access for cancer patients throughout the State of West Virginia to state-of-the-art clinical trials, develop new anticancer therapies, and contribute to the clinical science of advancing therapeutics for the cancer patient.
The CTRU is responsible for the registration of patients and/or participants and data acquisition for all cancer protocols, including Cancer Center investigator-initiated, institutional, pharmaceutical sponsored or cooperative group clinical trials at WVUH and MBRCC. The MBRCC presently has full member status in the National Surgical Adjuvant Breast and Bowel Project (NSABP, PI: J. Abraham) and participates in Eastern Cooperative Oncology Group (ECOG) trials through an affiliation with the University of Pittsburgh Cancer Institute.
The CTRU is part of the overall support for clinical trials research and is coordinated with the newly developed Protocol Review and Monitoring System (PRMS), and the the Data Safety and Monitoring Plan (DSMP), which is aligned with the priorities of clinical research as outlined by program and senior leaders. The coordination functions of the CTRU have been developed and redeployed to reflect the coordination of activities with the WVU IRB and supporting clinical trials research at potential partner institutions as the formative statewide clinical trials network is emerging. The responsibility of the CTRU is to coordinate these activities, providing oversight for research nurse training, quality assurance and audit review, and developing policy and procedures for clinical trials activation, accrual and management.
The policies and procedures which govern these activities are outlined in the MBRCC Clinical Trials Operations Manual also known as the “Blue Book”, (3rd edition, December 2012). All patients enrolled on a clinical trial are registered with their demographic information and eligibility verification in OnCore (Forte Research, Inc. Madision, WI). An enterprise class clinical and translational research software.
For NCI-sponsored early phase studies the CTRU submits data to the Clinical Trial Monitoring Systems (CTMS/ACES) for Phase I trials and to the Computer Data Update System (CDUS) for Phase II trials. All study coordinators and research nurses are trained in SAE identification and reporting per NCI guidelines and are familiar with NCI’s Adverse Event Expedited Reporting System (AdEERS).
For cooperative group and pharmaceutical protocols, the CTRU is responsible for the submission of the required data forms to the designated data center. Prior to protocol activation adverse event reporting (AERs) and clinical data reporting requirements are identified.
A major element of the Data and Safety Monitoring Plan (DSMP) are the interactions of the CTRU research nurses with the Patient Protocol Review Committees, the Clinical Trials Disease Teams, and ultimately the Data Safety and Toxicity Committee (DSTC). The CTRU also reports to the NCI PDQ system about disseminating protocol information.
The director oversees a research administrative and support team comprised of clinical trials research nurses, data managers, regulatory specialist, accountant, network coordinator, database manager and secretary. The Cancer Center supports the certification of all qualified research staff to either the Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).
The CTRU also provides important administrative and scientific direction to the protocol development process, Protocol Review and Monitoring Committee (PRMC), the Data Safety and Toxicity Committee (DSTC), and to NCI and other data reporting systems. In 2012, the CTRU oversaw the recruitment, data management and monitoring of 224 patients to Cancer Center therapeutic and non-therapeutic protocols.