Clinical Protocol and Data Management

Medical University Of South Carolina, Charleston SC

Investigators

Linked publications & trials

Abstract

Part I: Clinical Protocol and Data Management. The Clinical Protocol and Data Management (CPDM) function is supported through the concerted efforts of the Hollings Cancer Center (HCC) Clinical Trials Office (CTO), the HCC Quality Assurance and Education (QAE) unit, and the HCC Data Safety and Monitoring Committee (DSMC). The CTO provides centralized research services and oversight for coordinating and reporting on all oncology-related clinical trials at the Medical University of South Carolina (MUSC). Between 2018 and 2022, HCC recruited 8,962 individuals into all clinical research studies (1,080 interventional treatment, 4,528 interventional non-treatment, and 3,354 non-interventional accruals), and activated 338 studies, of which 85 studies represent institutional or external peer sponsorship. Part II: Data & Safety Monitoring. HCC’s institutional DSMP was last approved by the NCI in November 2022. The goals of the HCC DSMP are to ensure that Cancer Center research studies are conducted in compliance with federal and institutional requirements to ensure the safety and welfare of human participants. The QAE unit provides internal monitoring activities of PRC-approved trials in accordance with a risk-based monitoring plan, while the DSMC focuses quality assurance and safety monitoring upon MUSC investigator-initiated interventional trials. Part III: Accruing Women and Racial/Ethnic Minorities in Clinical Research. Under the ongoing active surveillance leadership of HCC and guidance from Community Outreach and Engagement (COE), CPDM supports clinical trial accrual comparable to HCC’s varied patient catchment area. HCC statistics support impressive strides in aligning demographics in patient accrual with SC demographics. Part IV: Accruing Individuals Across the Lifespan in Clinical Research. HCC accrues patients to clinical trials across the age continuum. In CY2022, sixty-two new pediatric patients were diagnosed and/or treated for the first time at MUSC, and a total of 97 pediatric patients were enrolled in clinical trials (23 treatment, 28 interventional non-treatment, and 46 non-interventional. Per SC Census Data, individuals 65 years and older make up 19% of the state population. SC state tumor registry data indicate 55% of cancer cases are elderly, while HCC’s tumor registry is 59% elderly. In CY2022, 800 elderly patients age 65 and older were enrolled in clinical trials (145 treatment, 182 interventional non-treatment, 473 non-interventional).