Clinical Protocol and Data Management

Northwestern University At Chicago, Evanston IL

Investigators

Linked publications & trials

Abstract

ABSTRACT – CLINICAL PROTOCOL AND DATA MANAGEMENT Clinical Protocol and Data Management (CPDM) is supported 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 clinical trials. Services offered to investigators include protocol development, regulatory services (including IND submission), study coordination, data management, centralized record keeping, multisite coordination, and quality monitoring. The office manages a large volume of trials and continuously aims to improve its capabilities and service. CTO accomplishments over the current grant period include increased staffing and reorganized staffing models; a process improvement project that has resulted in a 20% reduction in median contract negotiation timelines; increased use of external IRBs, and a reduction in activation timelines from 154 days at the time of the last competing renewal to 112 days in the last year. The number of open interventional trials has increased from 367 in 2018 to 429 in 2023. NCTN/ETCTN and Investigator-initiated trials (IITs) account for 65% of the LCC trial portfolio, with 89% of interventional trial accruals on such protocols. The CTO works closely with the Community Outreach and Engagement (COE) office during planning and implementation of clinical trial protocols. Leveraging the Lead Academic Participating Site (LAPS) grant, we have expanded trial access to 12 additional Northwestern Medicine locations and have seen an over twenty-fold increase in trial accrual at these LCC Network sites. The Data Safety Monitoring Committee (DSMC) plays a critical role in ensuring the effective execution of the NCI-approved LCC Data and Safety Monitoring Plan (DSMP). The DSMC assumes responsibility for safety reviews and monitoring of the progress of LCC Investigator-Initiated Trials (IITs). The DSMC convenes monthly to conduct safety reviews for all IITs, with the frequency of monitoring determined by risk stratification established during the Scientific Review Committee’s (SRC) initial review. Several initiatives are in place to address disparities in accrual of patients relative to the catchment area. Accrual of children to interventional trials remains strong with an increase to 166 in 2023 compared to 129 at the time of the last competing renewal. To improve representation of adults over 65, the LCC has been developing strategies to minimize barriers and facilitate trial designs specific to older adults. Interventional trial accruals of adults over 65 have increased from 338 at the time of the last submission to 730 in 2023, with an average annual accrual number of 754 for the entire period (2018-2023).