Clinical Trials Office
The IU Simon Cancer Center has a large clinical trials program. In 2012, 3,758 patients were enrolled in clinical trials, including interventional, epidemiologic, banking and correlative. The mission of the IU Simon Cancer Center Clinical Trials Office (CTO) is to support and facilitate the conduct of quality clinical research by IUSCC translational clinical investigators. The CTO is a centralized resource available to all clinical investigators of the IU Simon Cancer Center whose services enable the safe and efficient conduct of adult and pediatric trials. The CTO assists in protocol development, IND/IDE management and coordinates the scientific review of proposed trials by the Protocol Review and Monitoring System (SRC) of the cancer center.
The experienced support staff of the Clinical Trials Office provides essential services, which enable the clinical investigator to efficiently conduct clinical trials in an increasingly complex regulatory and financial environment. The CTO provides a comprehensive range of services. The complexity of both clinical and translational trials continues to increase at a time when the conduct of trials is under greater regulatory scrutiny. These services begin in the early stages of protocol development and continue throughout the study implementation, publication and long-term follow-up. There is a need to maximize the information yield of clinical trials and to assure human safety. The CTO facilitates the conduct of a successful clinical trials program of this magnitude by providing a professionally diverse, talented staff and highly efficient organization.