Clinical Protocol and Data Management

Case Western Reserve University, Cleveland OH

Investigators

Linked publications & trials

Abstract

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, 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 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 2023, 1980 patients were enrolled in Case CCC interventional trials, including 905 patients in treatment studies. In the same year, 25% of accruals to treatment studies and 37% of all interventional accrual was to IITs (peer-reviewed, institutional). There is a substantial commitment to support NCTN studies, with 318 patients accrued to interventional studies in 2023 (Case CCC was the 2nd highest accruing institution to the Lead Academic Participating Site [LAPS]). In 2023, 65 joint interventional trials were active at University Hospitals (UH) and Cleveland Clinic (CC), with 334 accruals to these trials during the year.