Clinical, Protocol, and Data Management

Baylor College Of Medicine, Houston TX

Investigators

Linked publications & trials

Abstract

Clinical Protocol and Data Management (CPDM) PROJECT SUMMARY/ABSTRACT The Clinical Protocol and Data Management component of the Dan L Duncan Comprehensive Cancer Center (DLDCCC) includes the Clinical Trials Support Unit (CTSU) and the Data Review and Safety Monitoring Committees. The CTSU provides central management, research support and oversight functions for the conduct of cancer-related clinical trials at all ambulatory care centers and hospitals that are part of the DLDCCC. The CPDM has seen a number of improvements in the last funding period. Compared to the last 5-year period, accruals to interventional and interventional treatment studies have increased by 110% and 12.7%, respectively. The CTSU workforce has improved with an enhanced salary structure and a flexible work schedule and employees are now rewarded for maintaining professional certification. CTSU workflow has improved with enhancements to OnCore, including the regulatory and financial modules. The median time to activation of NCTN studies has dropped dramatically to 43 days and industry studies to 51 days in 2023. We have initiated a cell therapy program at our safety net hospital and a formal phase I program in the DLDCCC. CTSU services are available to all members of the DLDCC engaged in clinical research. The major functions of the CTSU are to provide: 1) The necessary support for the conduct of cancer-related clinical trials including protocol development, clinical trials financial support, regulatory oversight, research coordination and nursing, and data management, 2) Clinical trials informatics expertise, especially maintaining an electronic database of cancer related clinical protocols, and monitoring and reporting on accrual and trial status, 3) Quality Assurance/Quality Control auditing and development and implementation of policies and standard operating procedures, 4) Ongoing education of investigators and staff in best practices in clinical research. The Data Review and Safety Monitoring Committees are separate from the operational aspect of clinical trials managed by the CTSU and function to ensure the safety of participants, the validity of data, and the appropriate termination of studies in the event that undue risks have been uncovered, or it appears that trials cannot be conducted successfully. The DLDCCC patient safety officer ensures that all data monitoring for Cancer Center trials is conducted in accordance with the approved data safety monitoring plan. The CPDM monitors and reports on accrual to ensure there is appropriate enrollment of all populations, including children and older adults, in clinical research.