The Clinical Trials Support Unit (CTSU) is a central resource for coordination and reporting on all cancer related clinical research within the College and its affiliated hospitals and ambulatory care centers. The CTSU facilitates liaison with investigators, cooperative groups, federal agencies, and the pharmaceutical industry. In the past 3 years, the CTSU has particularly focused on establishing clinical trials infrastructure for investigators and institutions with less prior experience and knowledge in this area in order to increase clinical trial enrollment to a wide spectrum of cancer-related studies. The CTSU has targeted hospitals and institutions with a higher proportion of minority and economically disadvantaged patients, providing greater access to participation in clinical research for these populations. The CTSU provides overall coordination of and reporting on cancer relevant clinical studies in the DLDCC via 4 major functions: 1) Assistance with regulatory and administrative matters relating to clinical research and trials, including IRB compliance and approval, ongoing amendments and renewal, external agency compliance (such as the FDA), maintenance of regulatory files, 2) Clinical trials informatics expertise especially maintaining an electronic database of cancer related clinical protocols, patient registry and clinical data, and monitoring and reporting on accrual, 3) Quality assurance auditing and personnel training and 4) Research nursing/clinical trials management especially for less experienced investigators or those with limited programs. The CTSU provides efficient, cost-effective support to aid Cancer Center investigators in the conduct of scientifically valuable cancer clinical trials and improves access to these trials, especially for underserved minorities. The main offices of the CTSU are in the Cancer Center administrative offices on the 4th floor of the Cullen Bldg at Baylor College of Medicine with CCGT and Pediatric CTSU offices in the Feigin Center. On site offices for Research Nurses/Coordinators are located in each of the College's major affiliated clinical facilities including the Baylor Clinic, Texas Children's Hospital, the Methodist Hospital (adult component of the CCGT program), the Ben Taub Hospital, and the Michael E. DeBakey VA Medical Center. The Resource Leader is Martha Mims, M.D., Ph.D.
The CTSU provides central management, oversight and quality control for the clinical trials effort of the DLDCC. The resource supports a centralized database of protocol-specific data, an updated list of active protocols and status reports on protocols and clinical trials accrual. Data auditing and training for clinical research personnel within the Cancer Center are also managed by the CTSU.
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