Clinical Protocol and Data Management

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CLINICAL PROTOCOL AND DATA MANAGEMENT PROJECT SUMMARY/ABSTRACT 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 provide a centralized resource for the oversight and management of clinical trials from concept development through reporting of study results. Services include assistance with concept development and protocol writing; feasibility assessment; budgeting and contracting; research nursing and data management; database development and oversight; regulatory management including IND applications; interactions with sponsors; study registration; quality assurance; staff education; and reporting of results. Data and safety monitoring to ensure the integrity of data and patient safety is a critical centralized function. 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. The Specific Aims are to: 1) Provide a highly efficient and coordinated infrastructure to assist clinical investigators in the development, conduct and reporting of clinical trials. 2) Oversee data integrity and ensure the safety of patients who participate in clinical trials. 3) Provide access to clinical trials for all cancer patients regardless of sex/gender, race, ethnicity, age, and socioeconomic status, and proactively identify and address barriers to clinical trial participation among patients, providers, research staff, and healthcare systems. 4) Support a robust portfolio of research studies relevant to children and address special considerations for children with cancer to facilitate their participation in clinical trials. In 2016, 2,474 patients were enrolled onto Case CCC interventional trials (73 percent increase since 2012), including 866 patients on treatment studies. In 2016, thirty one percent of accruals to treatment studies and seventy percent of all interventional accrual was to investigator-initiated trials (peer-reviewed, institutional). There is a substantial commitment to support of National Clinical Trials Network (NCTN) studies, with 209 patients accrued to treatment intervention studies in the third year of the NCTN. Furthermore, in 2016 the Case CCC enrolled and biopsied 93 patients on the NCI MATCH trial, supported by the Clinical Trials Units via rapid activation, centralized registration, and coordination of tissue acquisition and processing. !