The Clinical Research Committee (CRC) at the Lombardi Comprehensive Cancer Center (Lombardi) is responsible for reviewing clinical research protocols for scientific merit, ensuring prioritization of protocols based on scientific priorities and patient availability, and monitoring the scientific progress of cancer protocols. As part of the initial scientific review, the CRC also identifies protocols that need institutional data and safety monitoring oversight if a data and safety monitoring plan is already in place for the trial, Lombardi resources are not used for this purpose. For example, NCI/CTEP-sponsored phase I and II studies are reported by the principal investigator (PI) to the NCI/CTEP, and all clinical trials sponsored by the NCI Cooperative Group Program (CALGB, NSABP, ECOG, SWOG, and COG) comply with cooperative group data submission, reporting, review, and monitoring procedures. The CRC Co-Chairs specifically identify studies for which no formal data and safety monitoring plan exists, and the Pis of those studies report to and have their studies monitored and audited by the DSMC. The Lombardi Data and Safety Monitoring Plan was submitted to the NCI and approved on June 13, 2002. A copy of this plan will be available at the site visit The Data and Safety Monitoring Committee (DSMC) consists of clinical researchers, with representation from physicians, biostatisticians, pharmacists, and data managers. The DSMC meets quarterly to evaluate all investigator-initiated phase I and II studies, PI investigational new drug (IND)-holder phase I and II studies, and NCI-supported trials without any monitoring mechanism in place. Pis of studies requiring data and safety monitoring are required to submit a data and safety report every 3 months from the date of Institutional Review Board (IRB) approval. These reports address any changes made to the protocol, a summary of adverse events experienced by subjects on the study and include any serious adverse event report submitted by the PI. The report is reviewed at the quarterly DSMC meeting. All adverse events are reviewed quarterly for each study requiring DSMC review. This approach is designed to identify protocols that may place a patient at excessive risk for toxicity so that studies may be terminated or suspended accordingly. An internal review of each study is conducted every 3 months that consists of three medical charts and case report forms (or 10%, whichever is higher). Reports of these reviews are reviewed at the quarterly DSMC meeting. The DSMC provides a prospective analysis of data acquisition and safety at Lombardi in order to maintain excellent research data and patient safety. Specifically, the DSMC provide 'real-time' and frequent review of institutional phase I and II studies, as well as of NCI-sponsored studies that do not have an external monitoring plan.
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