Protocol Review and Monitoring System (PRMS)

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) ABSTRACT The Protocol Review and Monitoring System (PRMS) at the UCLA Jonsson Comprehensive Cancer Center (JCCC) has two separate, independent components, Disease Site Groups (DSGs) and the Internal Scientific Peer-Review Committee (ISPRC, aka PRMC), that provide rigorous scientific review and oversight of cancer clinical research. All study protocols undergo a formal two-stage review: stage-one by one of 15 DSGs; and stage-two by the ISPRC. Under the authority of JCCC Director Michael Teitell, MD, PhD (CMINT), and codified by the UCLA Vice Chancellor for Research, all interventional and non-interventional human subject cancer clinical research must undergo PRMS two-stage review to open. Administrative support for PRMS review is provided by the JCCC Clinical Research Unit (CRU). First-stage DSGs are tumor type or modality specific and evaluate accrual target, academic credit, study source, innovation, impact, feasibility, competition and prioritization, relevance to the JCCC catchment area, and study open duration. DSGs may require a study PI to consult with the JCCC Clinical Trials Access Advisory Committee (CTAAC) on a protocol accrual enhancement plan as a scored review criteria at second-stage review. Second-stage ISPRC review, led by Co-Chairs John Glaspy, MD, MPH (STT) and Albert Lai, MD, PhD (STT), begins only after DSG review and approval and has a broader Center perspective, evaluating scientific merit, statistical plan, portfolio fit and priority, patient population, clinical need, accrual enhancement plan, impact, and resource availability. ISPRC members cover the oncology disciplines including basic, clinical, and population scientists, biostatisticians, and a patient advocate. The ISPRC requires all interventional studies to have an appropriate Data Safety and Monitoring Plan. The ISPRC does not re-review protocols with NCI PRMS-acceptable external organization peer review. The ISPRC, Institutional Review Board (IRB), and a separate, independent Data Safety and Monitoring Board (DSMB) perform reviews in parallel, are complementary, and communicate regularly, but do not overlap in duties or scope. The ISPRC evaluates science, the DSMB evaluates safety and data integrity, and the IRB evaluates the ethical conduct of research involving human subjects. PRMS DSGs and the ISPRC monitor scientific progress and accruals. The ISPRC has sole authority to close trials for not meeting accrual targets or for lack of scientific progress. Should the ISPRC be notified of misconduct or other issues, study teams receive guidance on contacting appropriate authorities such as the IRB, FDA, NCI, and funding sponsors, as needed. PRMS has three Specific Aims: (1) To provide a rigorous, standardized, and consistent two-stage review of all JCCC cancer clinical studies; (2) To assess progress of ongoing trials for accrual and performance, and close non-performing studies; and (3) To support and monitor participation in cancer clinical research across populations. Overall, PRMS mechanisms are in place so cancer clinical studies can employ sound scientific and statistical approaches to produce impactful and valid advances for the Los Angeles County (LAC) catchment area and beyond.