The purpose of the Clinical Trials Support Unit (CTSU) is to provide a central Cancer Center resource to coordinate and assist with all cancer-related clinical research within the affiliated hospitals and ambulatory care centers of BCM. It will foster the establishment and maintenance of clinical trial related infrastructure, especially for investigators and institutions with less prior experience and knowledge in this area. By this mechanism, it will enable and increase clinical trial enrollment to a wide spectrum of cancer-related studies. The Unit's efforts will particularly target hospitals and institutions with a higher proportion of minority and economically disadvantaged patients, providing greater access to participation in clinical research for these populations. In addition the CTSU will facilitate liaison with external co-investigators and cooperative groups, federal agencies, and the pharmaceutical industry. The CTSU will provide three major services to Cancer Center investigators: 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, and assistance with internal and external audits; 2) Provision of research nursing/clinical trials management especially to less experienced investigators or those with limited programs; 3) Provision of data management and bioinformatics expertise including database instruction and maintenance and internal audits. The CTSU will thus provide efficient, cost-effective support to aid Cancer Center investigators in the conduct of scientifically valuable cancer clinical trials and will improve access to these trials, especially for underserved minorities. The main offices of the CTSU are located within the Cancer Center administrative offices on the fourth floor of the Cullen Bldg at Baylor College of Medicine. Satellite offices for Research Nursing/Research Coordinators are located in each of the College's major affiliated clinical facilities including the Baylor Ambulatory Care Clinic, St. Luke's Episcopal Hospital, Texas Children's Hospital, the Ben Taub General Hospital, and the Michael E. DeBakey VA Medical Center. The Resource Leader is Martha Mims, M.D./Ph.D.
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