CLINICAL TRIALS SHARED RESOURCES

Duke University, Durham NC

Investigators

Linked publications & trials

Abstract

CLINICAL TRIALS SHARED RESOURCE Jeffrey Crawford, MD, Director The Clinical Trials Shared Resource (CTSR) is pivotal to the conduct of clinical research within the Duke Comprehensive Cancer Center. This facility has evolved over the past 15 years from an embryonic one-person protocol office to its current staff of 42, centralizing protocol and PRMS administration, the Clinical Trials Quality Assurance and Education Program, and the Duke Cancer Clinical Trials Service (DuCCaTS). When clinical trials operations and data management were added to the resource in early 1998, DuCCaTS became a full-service operation offering start-tofinish clinical trials services to Cancer Center members. The administrative functions (protocol administration, PRMS administration, ProTRAK database and protocol archives, patient registration, quality assurance and education) of the CTSR are centralized within the Protocol Administration Office (PAO). All cancer center protocols, regardless of sponsorship, are processed through the PAO for review by the PRMS and abstracted into the central database (ProTRAK). All cancer center protocol subjects are registered through the PAO for entry in ProTRAK (average annual total accrual based on last 6 years:l,285 patients on therapeutic trials; 4,850 subjects on non-therapeutic trials). Personnel providing DuCCaTS' start-up services are also housed in the PAO. The Core Audit Team is staffed by members of the PAO. Currently, there are 10 staff members. Clinical trials operations is organized into disease and modality-specific teams of Clinical Research Nurses (CRNs) and data managers (CRAs). The current teams, with total staffing at 27, are aligned with the existing programs of Breast and Ovarian Oncology, Experimental Therapeutics, Cancer Immunobiology, and Radiation Oncology. The CTSR also supports a team at the Durham VA. These teams currently operate approximately 122 clinical trials and enroll approximately 550-700 subjects per year. The goal of the CTSR is to align its services in support of the scientific priorities of the cancer center. The Clinical Trials Service is used almost exclusively by peer-reviewed, cancer center members with highest priority given to peer-reviewed research. Chargebacks are on a sliding scale, with the biggest discounts provided to cancer center members conducting peer-revi ewed re search.