) The Clinical Trials Core is an integral part of the CCC. The CTO is a center of multi-disciplinary clinical trials support activity, serving the needs of cancer researchers throughout the Cancer Center, in the academic Departments of Medicine, Radiation Oncology, Gynecology, Pediatrics, Surgery, Urology, Otolaryngology, and Neurology. The scope of the CTO activities includes national cooperative groups, industrial, NCI sponsored, multi-institutional and local, investigator initiated studies. The objective of the Core is to enhance the efficiency and cost effectiveness of the implementation and conduct of clinical trials by providing CCC investigators with services including patient recruitment and registration to trials; data collection; review of all new cancer-related trials; annual review of all ongoing trials; preparation of protocol specific consent forms and protocol submission to IRB; advisory function for investigators regarding protocol guidelines; centralized repository of all clinical trials; assurance of Investigator Compliance with Good Clinical Practice Guidelines; assistance with protocol development, writing and budget preparation. In collaboration with the Biostatistics Core, all cancer related protocols and annual protocol renewals are reviewed by the Cancer Center Clinical Trials Committee prior to submission to the Wayne State IRB. Overall, 33 individuals provide service as members of the Clinical Trials Core, supporting more than 400 active protocols. These activities have resulted in consistent increases in accrual to clinical trials over the years with excellent representation of minorities and women. Protocols are available via the CCC Web site, replacing protocol books, increasing the ease of access to protocol information with associated cost savings.
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