The Case Comprehensive Cancer Center (Case CCC) is committed to the translation of laboratory insights into routine clinical care. This requires a deep infrastructure to support the conduct of clinical trials of new interventions designed to prevent, diagnose and treat cancer, and improve the long-term outcomes for cancer survivors. The Clinical Protocol and Data Management services of the Case CCC CRO provide a centralized resource for the oversight and management of clinical trials from concept development through registration and reporting of study results with ClinicalTrials.gov.
The Clinical Trials Units (CTUs) services include assistance with concept development and protocol writing; feasibility assessment; budgeting and contracting; research nursing and data management; regulatory management including IND applications; interactions with sponsors; quality assurance; and staff education.
The Protocol Review and Monitoring Committee (PRMC) plays a critical role in protocol review and monitoring to assure that clinical trials are scientifically sound, and that approved studies maintain adequate patient accrual and scientific progress.
The OnCore® Clinical Trials Management System is the On-line Clinical Oncology Research Environment (OnCore). This internet-based solution provides the security, auditability, and process visibility that are essential to meeting the demands of managing cancer-related clinical trials.
The Data Safety and Toxicity Committee (DSTC) is a critical centralized function that provides data and safety monitoring to ensure the integrity of data and patient safety. Investigator-initiated protocols must include the Case CCC NCI approved Data Safety and Monitoring Plan (DSMP).
The Minority Accrual Committee’s (MAC) mission is to increase awareness and improve institutions’ ability to engage minority populations in understanding, communicating about and decision making regarding participation in research studies.
As our goal is to ensure access to clinical trials for all of our patients, special efforts are undertaken to provide the opportunity to participate in clinical trials regardless of sex/gender, race, ethnicity, socioeconomic status, or age.