Clinical Trials Management Shared Resource

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The Clinical Trials Management Shared Resource (CTMSR) is led by Raymond P. Perez, MD and provides comprehensive, centralized support services that span the life cycle of cancer clinical trials from concept through manuscript, and assures that the patient population and resources needed to successfully conduct these trials in compliance with all federal, state and local regulations are in place. A resource staff of 35.6 FTE manage a portfolio of 116 clinical protocols (19 institutional investigator-initiated, 31 industrial, and 65 from cooperative groups). The CTMSR is functionally organized into four distinct groups: (1) Study Implementation and Regulatory Compliance (11 FTE) provides project development/management and regulatory affairs functions, and administrative support for the KUCC Protocol Review and Monitoring System; (2) Research Finance (2 FTE) provides comprehensive budget development, financial management for active protocols, and research billing compliance; (3) Clinical Trials (17.6 FTE) provides research nursing, study coordination, and data management coordination; and, (4) Research Assurance (1 FTE) provides monitoring, auditing, and quality assurance/control (QA/QC) oversight of clinical research and administratively supports the KUCC Data and Safety Monitoring Committee. The CTMSR has enabled a nearly 5-fold increase in clinical trials accrual at KUCC since 2006, particularly to institutional investigator-initiated trials (IIT) that now account for almost 63% of all therapeutic enrollments. Additional operational highlights include development and improvement of standard operating procedures across the resource, particularly for financial management, where process improvements yielded a sustainable business model, and support for local and regional collaborations at multiple affiliated sites. In summary, the CTMSR has facilitated significant growth of investigator-driven clinical research at KUCC, while implementing and administering cost-effective processes to ensure that the research activities have scientific merit, protect safety, maintain scientific integrity, and are fiscally sound.