Clinical Protocol and Data Management

Dartmouth College, Hanover NH

Investigators

Linked publications & trials

Abstract

SUMMARY: CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) The Office of Clinical Research (OCR) is the established office within the Dartmouth Cancer Center (DCC) that supports clinical cancer research at Dartmouth. The OCR provides support for investigator-initiated trials (IIT), cooperative group trials (as an NCTN Lead Academic Participating Site, NCI ETCTN, and Full Member of Alliance, NRG, and ECOG-ACRIN), and industry-sponsored studies. The OCR is a service group that provides DCC investigators centralized support for protocol development and review, screening for potential research participants, study data management, monitoring for cooperative group studies, and liaison with federal and industry sponsors and regulatory bodies. The OCR provides resource support to the DCC clinical protocol scientific review committee, known locally as the Clinical Cancer Review Committee (CCRC), as well as the Quality Improvement Committee, the Clinical Trial Investigational Order Set Committee, and the Data and Safety Monitoring Committee (DSMC). The OCR has been active in NCI initiatives, such as the Clinical Trial Reporting Program’s (CTRP) Centralized Data Table 4, as well as overseeing the successful competing re-application of DCC as an NCTN LAPS. The OCR has a track record of piloting new endeavors for the research enterprise within the Dartmouth Health system, as it supports the largest single research group in the parent organization. It convened a Lean Six Sigma Clinical Trials Process Improvement Project that identified root causes for a downward trend in accruals and proposed initiatives to reverse it, including an additional $1-million-per-year investment to enhance OCR capabilities, addition of 11 new OCR FTEs, designation of COG Research Directors with FTE support, and establishment of an Accrual to Clinical Trials Initiative. Over the last four years, a total of 9,855 adult subjects and 208 pediatric subjects were enrolled in cancer trials; 6,707 subjects in interventional trials; and 3,356 subjects in non-interventional trials. During the 12-month reporting period, 1,656 patients were accrued to interventional clinical trials; this includes 551 patients accrued to DCC IITs. We exceeded our LAPS target accruals two-fold for 2022 and 2023. The adult subject interventional enrollment included 71.0% women (which, percentage-wise, is higher than the catchment area female cancer population of 51.0%), 82.4% rural patients (catchment 80.7%) and 36.3% over 75 years of age (catchment 25.8%). Regarding data and safety, DSMC is a chartered multidisciplinary committee charged with overseeing monitoring of participant safety, conduct and progress of research protocols, and the validity and integrity of clinical trials data at DCC and its subsites that are not reviewed by another study-specific safety and data monitoring committee. DSMC has the authority to require protocol amendments necessary to ensure participants’ safety, suspend study enrollment and study activities, or recommend study closure to CCRC. The DSMC and the IRB have the authority to immediately suspend accrual and protocol activities until concerns related to adverse events are addressed.