The Winship Clinical Protocol and Data Management (CPDM) unit provides the infrastructure for clinical researchconducted at Winship. CPDM has three main objectives: supporting the safe and ethical conduct of clinicalresearch; promoting the generation of high quality data; and increasing access to clinical trials for subjects in theWinship catchment area, with an emphasis on underrepresented populations. CPDM includes the WinshipClinical Trials Office (CTO), clinical data management team, regulatory specialists, quality assurance team(QAT), and the Data Safety and Monitoring Committee (DSMC). The CTO provides the infrastructure for allaspects of trial conduct including design, regulatory processes, activation, conduct, data collection, and analysis.The CTO also provides training and education in clinical research for Winship members and staff. The clinicaldata management team and the regulatory specialists are organized in cancer disease site-based teams. Teamshave dual reporting to the physician leaders of the respective disease site-based teams and to the CTO assistantdirectors. The CTO has a specialized team focused on the conduct of multi-institutional trials for which Winshipinvestigators serve as PI's. This team coordinates trial conduct and provides on-site or remote monitoring ofparticipating institutions. The Winship trial portfolio has an intentional distribution of institutional, industry-sponsored, externally peer-reviewed, and NCI-supported National Clinical Trials Network (NCTN) trials. TheQAT coordinators audit institutional and NCTN trials in real time to ensure compliance. The DSMC oversees theimplementation of the Winship data safety and monitoring plan. The primary focus of the DSMC is to ensure thehighest level of compliance in the institutional, NCI-funded, and NCTN trials. Recent analyses of trends ofmeasurable outputs reveal significant improvements in key measures of Winship clinical trial conductincluding accrual to trials, reduced trial activation times, and compliance with study protocolrequirements. During the present funding period, Winship has developed new research-related standardoperating protocols (SOP), improved staffing of the CTO to meet the growth in clinical trials accrual, andimplemented clinical trials data management software. A software solution for biospecimen tracking and anothersoftware system for radiologic response evaluation have been implemented during the current funding period.During the next funding period, Winship will increase patient accrual to clinical trials with an emphasis on theaffiliated Winship facilities, develop stronger clinical research infrastructure at those sites, increase underservedpopulations' access to clinical trials, increase clinical trial access within the Winship Cancer Network, andimprove clinical trials informatics platforms.
Showing the most recent 10 out of 331 publications
