Protocol Review and Monitoring System

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ABSTRACT–Protocol Review and Monitoring System The conduct and oversight of the lifecycle of clinical trials and the safety of participants are achieved through well-defined processes in study development, review, and performance. In addition to the important roles of the principal investigator, sub-investigator(s), research team(s), and the St. Jude Comprehensive Cancer Center (SJCCC) programs to this endeavor, the Clinical Trials Scientific Review Committee (CT-SRC) is at the core of this process. The CT-SRC is charged with the Protocol Review and Monitoring System (PRMS). The CT-SRC reviews all new prospective clinical trials, which have been first discussed within the pertinent SJCCC Program to ensure that they are aligned with the respective Program's scientific goals. If so, the trial is prioritized among the Program's other competing protocols. After programmatic review and endorsement, the CT-SRC reviews the scientific rationale, feasibility, and study and biostatistical designs and oversees the progress of all institutional protocols to ensure that the initial study design, timely accruals, and stopping criteria are followed and that patient safety is maintained. In addition, the CT-SRC is empowered to modify the conduct of studies and close them, as needed. Committee members include individuals with expertise in clinical research, oncology disciplines, biostatistics, and translational sciences. In July 2012, the CT-SRC implemented a Concept Submission and Review process to precede full protocol development. Additional changes made during the funding period include adopting a formal reviewer worksheet to focus the fundamental review criteria and improve documentation, formalizing a policy for accrual monitoring by the CT-SRC, strengthening the committee's membership with inclusion of additional senior researchers, and implementing the Late Effects and Behavioral Research Subcommittee. Staff in the Central Protocol and Data Monitoring Office assist principal investigators with electronic submissions to the review committees and prepare documents for the CT-SRC. They also coordinate the meetings and communications between the investigators and the CT-SRC. The CT- SRC acts independently of the St. Jude Institutional Review Board and the safety oversight processes (i.e., the external Data Safety and Monitoring Board and the Internal Monitoring Committee). During fiscal year (FY) 2015– FY2017, the CT-SRC reviewed and approved the prioritization of 109 new cancer studies and reviewed 73 concepts. Sixty-two (57%) of the new studies were SJCCC investigator–initiated, externally peer-reviewed trials. Of the 109 studies reviewed, 8 (7%) were disapproved or tabled. During this same period, the CT-SRC monitored 382 studies for accrual and 775 for scientific progress, including studies closed to accrual but not yet completed. During this same period, 75 studies were closed, 8 of which because of low accrual. In summary, the PRMS evaluates and monitors all prospective clinical trials for scientific merit and alignment with the goals of the SJCCC, ensures that the aims of the protocols are on track for completion within the estimated time frames, and determines their relevance to contemporaneous science.