Protocol Review and Monitoring System

Vanderbilt University Medical Center, Nashville TN

Investigators

Linked publications, trials & patents

Abstract

CCSG COMPONENT 004 – PROTOCOL REVIEW AND MONITORING SYSTEM PROTOCOL SUMMARY/ABSTRACT The Scientific Review Committee (SRC) ensures that all cancer-relevant interventional trials conducted under the auspices of Vanderbilt-Ingram Cancer Center (VICC) are of the highest scientific quality, follow responsible conduct of research principles, and have significant potential impact for patients. In addition, there is an intentional focus to develop a portfolio of interventional trials that meet the needs of the catchment area and assure diversity of participants, and inclusion across the lifespan. Protocols requiring full committee review are evaluated for appropriate scientific rationale, clearly defined specific aims, achievable study endpoints, research integrity, a plausible biostatistical plan, feasibility, and a well-justified ability to accrue eligible patients from the VICC catchment area. These criteria exist to ensure that the study design supports the completion of its scientific goals. This focus on the scientific integrity of the trial clearly sets the SRC's role apart from the Vanderbilt Institutional Review Board (IRB), in that the SRC is focused on sound science with potential of translation to cancer care, while the IRB is primarily concerned with patient safety. The SRC and IRB have two separate functions and yet both complement each other by ensuring the integrity of the study through a sound scientific approach while also considering the protection of all participants. The IRB does not play a role in determining the extent of Cancer Center support that a protocol should receive. However, the SRC is responsible for prioritizing each protocol and providing recommendations regarding Cancer Center support, which includes CTO work queue management and financial support for institutional trials or those not fully funded by an extramural sponsor. In addition to ensuring a high level of scientific merit and appropriate prioritization of VICC interventional trials, the SRC oversees the progress of all active interventional protocols by routinely monitoring the patient accrual and closing studies that do not demonstrate scientific progress and adequate accrual. Low accruing studies involving rare diseases and studies that advance key areas of focus and align with the Cancer Center's strategic plans will be given special consideration. The SRC will also review any protocol changes that have a significant impact on the design or scientific rationale for an ongoing interventional trial. The SRC also reviews trials to ensure that they are consistent with VICC's commitment to addressing health disparities in clinical trial participation. The SRC provides special attention to trials targeting cancers that disproportionately affect minority populations.