Clinical Protocol and Data Management (CPDM)

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Project Summary/Abstract: Clinical Protocol and Data Management The Office of Clinical Research (OCR) is the established office within the Norris Cotton Cancer Center (NCCC) which 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 [LAPS], NCI ETCTN, and Full Member of Alliance, NRG, and ECOG-ACRIN), and corporate-sponsored studies. The OCR is a service group within NCCC to provide investigators centralized support and study data management, as well as protocol development, support for monitoring for cooperative group studies, screening for potential research participants, and liaison with federal and industry sponsors and regulatory bodies. The OCR provides resource support to the NCCC clinical protocol scientific review committee (known locally as the Clinical Cancer Review Committee [CCRC]), the Quality Improvement Committee, the Clinical Trial Investigational Order Set Committee (CTIOSC), and the Data Safety Monitoring and Accrual Committee (DSMAC). 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 re-application of NCCC as an NCTN LAPS. The OCR has a track record of piloting new endeavors for the research enterprise within the Dartmouth-Hitchcock Health system, as it supports the largest single research group in the parent organization. Over the last four years a total of 2,392 adult subjects and 129 pediatric subjects were enrolled in cancer research trials at Dartmouth; 1,432 adult subjects in interventional trials, and 687 adult subjects in non-interventional trials. During the twelve-month reporting period, a total of 758 patients were accrued to NCCC clinical trials. This includes 608 patients accrued at NCCC and 150 patients accrued to NCCC investigator-initiated trials open at other institutions. The adult subject enrollment included 61% (371) women, which percentage-wise is higher than the catchment area female cancer population of 53% (female n=6,326 out of 11,984 cancer patients). With regard to data safety, DSMAC 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 NCCC and its subsites that are not reviewed by another study-specific safety and data monitoring committee. DSMAC has the authority to require protocol amendments required for participants’ safety, suspend study enrollment and study activities, or recommend study closure to NCCC’s CCRC. For specific protocols, independent internal monitoring assesses PI and team qualifications, as well as OCR regulatory, data integrity, and pharmacy compliance. The DSMAC and the IRB have the authority to suspend immediately accrual and protocol activities until concerns related to the adverse events are addressed. CCRC and the IRB have the authority to close a study immediately due to an unacceptable level of risk to study subjects or scientific integrity. CCRC has authority to close studies due to failure to achieve accrual goals and/or scientific progress.