Clinical Protocol and Data Management

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ABSTRACT – Clinical Protocol and Data Management The Central Protocol and Data Monitoring Office (CPDMO) within the St. Jude Comprehensive Cancer Center (SJCCC) provides centralized administrative, regulatory, and educational services for clinical trials-related activities. It is the coordinating center for protocol standardization, regulatory and compliance guidance, administrative submissions, protocol registration data, and monitoring. The CPDMO is integral to the Clinical Trials Administration (CTA), which provides comprehensive infrastructure for conducting SJCCC clinical trials. Together, the CTA and CPDMO perform the following functions to provide outstanding clinical trials support to SJCCC members: (1) Facilitate the development of high-quality clinical trials, within a standardized framework, to meet institutional and federal requirements. (2) Maintain a centralized submission process for institutional review and approval. (3) Set standards by fostering consistent conduct and compliance through the monitoring of all clinical trials. (4) Ensure appropriate participant enrollment via a centralized clinical trials registration system. (5) Provide infrastructure and coordinate trials at affiliate and collaborating institutions. (6) Adhere to the Data Safety Monitoring Plan, which was revised and approved by the NCI in August 2017. The CPDMO also provides administrative support to the Clinical Trials Scientific Review Committee to ensure the thorough scientific review of all trials in the SJCCC. Studies are monitored commensurate with the degree of risk to participants and the size and complexity of the study. The SJCCC's Data Safety Monitoring Board is composed of external experts who independently oversee institutional Phase III trials and high-risk trials; an Internal Monitoring Committee assesses findings from individual audit reports and safety trends and recommends educational and corrective actions. Trial monitoring and safety reporting is the responsibility of all members of the clinical trial process. Particular attention is paid to monitoring investigator-initiated trials (IITs), especially those with no external monitoring program. The CPDMO presently includes 42 staff members. Over the current funding period, the number of new pediatric patients with cancer increased 11%, from 459 in FY 2013 to 516 in FY2017: 60% enrolled into interventional therapeutic trials, and 90% of those were in institutional IITs. Similarly, the CPDMO assisted with 5,470 enrollments into interventional (therapeutic and nontherapeutic) trials, a 23% increase in accrual into this category, compared to the previous funding period. In addition, we assisted with 30,071 enrollments into non-interventional clinical trials. During the current funding period, the CPDMO managed more than 406 prospective trials, of which 52% are institutional IITs. During FY2017, the CPDMO's portfolio, subdivided by sponsor, included 61% IIT/peer reviewed, 32% national alliance/consortia, and 7% industrial. The SJCCC supported 30 investigational new drug applications and new device exemptions for 36 IITs. Presently, the CPDMO supports 116 active multisite IITs. The CPDMO is committed to serving all SJCCC members by supporting the efficient and effective conduct of high-quality translational and clinical pediatric cancer research.