The Cancer Clinical Trials Office (CCTO)—operated by the Clinical Protocol and Data Management team—assists Tisch Cancer Institute investigators in the development , conduct, and reporting of innovative clinical research in an efficient, regulatory-compliant, and scientifically sound manner. The CCTO comprises specialized units that support disease-specific research teams. It provides study coordination, data management, regulatory management, pre-award budgeting, training and education, all in a manner that complements the Protocol Review and Monitoring System.
All cancer clinical trials are monitored according to guidelines in the TCI Data and Safety Monitoring Plan (DSMP). A formal Data and Safety Monitoring Committee (DSMC) ensures that TCI investigator-initiated clinical trials are compliant with the DSMP. The DSMC reviews, on an ongoing basis, data regarding safety and efficacy from active investigator-initiated clinical trials deemed high-risk to ensure the safety of study participants.
Clinical trials at TCI include significant percentages of patients representing minority populations and women, as well as pediatric and elderly patients.