Clinical Protocol and Data Management

Northwestern University At Chicago, Evanston IL

Investigators

Linked publications, trials & patents

Abstract

ABSTRACT – CLINICAL PROTOCOL AND DATA MANAGEMENT Clinical Protocol and Data Management (CPDM) is overseen by the Lurie Cancer Center (LCC) Clinical Trials Office (CTO). The CTO provides a centralized resource to facilitate the development, conduct, and oversight of cancer-relevant clinical trials at the LCC. The office manages a large volume of trials, with about 30% increase in accrual over the project period (389 interventional trials with 2,367 participants enrolled in 2013, vs. 357 trials with 3,059 participants enrolled in 2016). Support services offered to investigators include protocol development, regulatory services (including IND submission), study coordination, data management, maintenance of centralized record keeping, and multisite coordination. CTO accomplishments over the grant period include increased and reorganized staffing to better serve PIs; creation of a Logistics Team; and increased staffing/integration of the finance team to reduce study activation times, creation of a web-based tool (LaunchTrack) to track key study activation milestones, and improved clinical research education and training for CTO staff and PIs. Data, Safety and Monitoring activities are an integral part of the LCC's robust clinical research oversight system, which is comprised of multiple teams and committees that work collaboratively, including: Disease Teams, Scientific Review Committee (SRC), Data Safety Monitoring Committee (DSMC), and Clinical Trial Audit Committee (CTAC). Disease Teams manage clinical trials portfolios, and endorse scientifically sound protocols that are submitted to the SRC for scientific evaluation and approval. The SRC is responsible for reviewing scientific merit, priorities, and progress of the clinical protocol research at the LCC (described in the PRMS section of this application). The activities of both the DSMC and the CTAC ensure that the NCI-approved LCC Data and Safety Monitoring Plan (DSMP) is effectively executed. LCC serves a 9-county catchment area (CA) that represents a diverse community. Minority accrual by ethnicity is robust (~20% accrued to interventional trials) over this grant period. Although accrual of African Americans to interventional trials has more than doubled since last grant period (from 4.7% in 2012 to 12.3% in 2016) and it closely resembles the percentage of patients seen at the LCC, it is below the catchment area proportion. The LCC has developed a series of initiatives (detailed in Part 3: Inclusion of Women and Minorities below) to address disparities in accruals among African Americans relative to the catchment area. Since the last site visit, the number of analytic pediatric cancer cases has increased by 20%, now at 284 cases, and accrual of children remains strong with 129 interventional accruals in 2016. In the most recent 12 months, accrual of women to interventional trials stands above catchment area rates at 58.9% (51.0% LCC CA population; 51.3% LCC CA incidence; 54.2% LCC patient population).