Clinical Protocol and Data Management

Emory University, Atlanta GA

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY/ABSTRACT CLINICAL PROTOCOL AND DATA MANAGEMENT The Clinical Protocol and Data Management (CPDM) oversees all cancer clinical research at Winship Cancer Institute of Emory University (Winship). CPDM has three objectives: (1) supporting safe and ethical conduct of innovative and transformative clinical research; (2) promoting high-quality data generation; and (3) increasing trial access for patients in the catchment area, emphasizing underrepresented populations. CPDM includes the Winship Clinical Trials Office (CTO), clinical data management team, regulatory specialists, quality management (QM), training/education, and the Data Safety and Monitoring Committee (DSMC). This research infrastructure is led by interim Associate Director for Clinical Research Edmund Waller, MD, PhD (CI), and CTO Medical Director R. Donald Harvey, PharmD (DDT), under the direct leadership of Winship Executive Director Suresh Ramalingam, MD (DDT). CTO operational leadership is provided by CTO Director Amy Overby, who oversees all clinical research staff and a group of experienced managers across each CTO function. The CTO provides infrastructure including trial development, activation, conduct, data collection and analysis, and QM monitoring (including in-person/remote site) and audits with a specialized team focused on multi-institutional trials. In addition, the CTO provides orientation and ongoing training for Winship members, faculty, and staff across all aspects of clinical research. The clinical data management team and regulatory specialists are organized by cancer site and treatment modality working groups. The Winship trials portfolio is balanced between institutional, industry-sponsored, externally peer-reviewed, and NCI-supported National Clinical Trials Network (NCTN) and Experimental Therapeutics Clinical Trials Network (ETCTN) trials. The DSMC oversees implementation of the Winship Data Safety and Monitoring Plan (DSMP) to ensure a high level of compliance. During the 2017-2021 funding period, 936 interventional and non-interventional protocols were activated at Winship. CPDM also supported the recruitment of 3,940 accruals to interventional treatment trials (representing a 23% increase compared to prior reporting period) across 732 protocols; approximately 41% of enrollments were on institutional or externally peer-reviewed trials. Of these, Black patients comprise 25% of the interventional treatment accruals at Winship, which is comparable to the proportion of Black cancer patients in Georgia. The DSMC monitored 358 protocols, resulting in 549 reviews of IITs and national group trials. Analyses of performance metrics for trial conduct demonstrate steady improvements in key measures including accrual, activation times, and protocol compliance. Currently 333 adult therapeutic clinical trials, and 97 pediatric therapeutic trials are open to enrollment at Winship. During the next funding period, Winship will continue to increase patient accrual with an emphasis on the affiliate sites and continued focus on historically underrepresented groups.