Protocol Review and Monitoring System

项目摘要-协议检讨及监察系统

PROJECT SUMMARY - Protocol Review and Monitoring System (PRMS) At the USC Norris Comprehensive Cancer Center (NCCC), PRMS functions are performed by the Clinical Investigations Committee (CIC) which serves as the Center's scientific review committee. The CIC is co-chaired by Drs. Syma Iqbal (TACS) and Ann Mohrbacher (TACS). All cancer protocols undergo a two-step review prior to submission to IRB. Step 1 is a standardized Disease Team (DT) review coordinated by the Clinical Investigations Support Office (CISO) DT managers. In the current grant period, we revamped the Stage 1 process to standardize the reviews and enhance interactions between DTs and NCCC Research Programs, particularly the Translational and Clinical Sciences (TACS) Program. If the protocol is approved by the DT, it proceeds to Step 2, the scientific review by the CIC. Only protocols that receive approval by the CIC can be submitted and reviewed by IRB. The accrual of women, minorities, and patients across the lifespan is considered at each step of the process as an evaluation criterion, as is catchment area relevance. In 2019, CIC reviewed 117 clinical trials, 25 of which were institutional or externally peer-reviewed. Important new PRMS developments in the current cycle include: a new mandatory “design and feasibility consultation meeting” for investigator- initiated trials (IITs) which ensures early input from biostatisticians and CISO leadership; usage of a newly updated standardized protocol template; and more rigorous DT oversight. In addition, a rapid activation pilot program for select high priority early phase trials was instituted in 2018-2019 with time to activation of 8-10 weeks. Once protocols are activated, they are monitored for accrual and scientific progress by the Scientific Progress and Accrual Monitoring Subcommittee of the CIC based on an established NCCC accrual monitoring policy. Key accomplishments resulting from these process improvements include: 1) activation timelines have decreased by 57% from 42 weeks in 2015 to 18 weeks in 2019; 2) average time from new protocol CIC review meeting to completion of CIC review decreased by 80% (from 5 weeks in 2015 to 1 week in 2019); and 3) a dramatic increase in the number of interventional trials closed for poor accrual (from 11 in 2015 to 20 in 2019 and 40 in 2020). Low accruing studies that were permitted to remain open met specific criteria, such as an adequate remedial plan that resulted in improved accrual on subsequent monitoring or prior strong overall accrual that slowed down due to cohort closures. Future plans include: a) further efforts to reduce time to activation; b) expansion of support for IITs including protocol writing support (initiated in 2020) to enhance the quality and speed of trial development; and c) a new CIC mentorship program to train junior faculty to become CIC members and reviewers.