Clinical Protocol and Data Management

University Of Rochester, Rochester NY

Investigators

Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM): ABSTRACT PART I: CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM). The Clinical Trials Office (CTO) at the Wilmot Cancer Institute (Wilmot) is comprised of >100 FTEs who provide centralized research support services to more than 60 cancer investigators. Services include comprehensive regulatory support from protocol conception to activation, Investigational New Drug application support, and ClinicalTrials.gov registration and results reporting. The CTO also optimizes accrual to externally peer-reviewed, investigator-initiated, National Clinical Trials Network (NCTN) and industry-sponsored trials by providing a centralized core of trained clinical research coordinators, research nurses, data managers, and technical associates to support Wilmot investigators. Research coordination and protocol compliance is enhanced through the fostering of investigator-patient-CTO interaction, collaboration, and teamwork. The CTO prospectively manages protocol and regulatory compliance and monitors data accuracy and timeliness. As the central data repository for all oncology-related trial activities, the CTO provides comprehensive reports and performance metrics to Wilmot leadership. In 2023, Wilmot CPDM supported a portfolio of 147 interventional treatment, 44 interventional non-treatment, and 30 non-interventional studies. Accrual to all studies resulted in 1,939 participants enrolled, which is comprised of 427 interventional treatment accruals, 1,002 interventional non-treatment accruals, and 510 non-interventional accruals. PART II: DATA AND SAFETY MONITORING (DSM). For locally developed investigator-initiated studies, Wilmot’s DSM Committee (DSMC) performs risk-based monitoring to ensure the highest levels of patient safety. The DSMC is administratively supported by the Quality Assurance Unit in accordance with Wilmot’s DSM Plan. In 2023 Wilmot DSMC provided oversight for 45 studies. PART III: PARTICIPATION IN RESEARCH. Wilmot maintains and supports multiple, proactive efforts to promote broad recruitment. In 2023 among the 1,429 individuals enrolled in interventional studies, the distribution was comparable to or exceeded cancer incidence demographics in the catchment area. PART IV: PARTICIPATION ACROSS THE LIFESPAN IN RESEARCH. Wilmot supports the NIH policy of promoting clinical research for people of all ages. Wilmot is internationally recognized as a leader in geriatric oncology. Clinical research opportunities for young people are offered through locally developed trials and national groups. In 2023, 54% of subjects enrolled in interventional treatment studies were 65 years. This far exceeds national benchmarks of 40%. Twelve patients (<18 years) were enrolled on interventional treatment studies, representing 18% of pediatric analytic cases.