CORE--CLINICAL TRIAL PROTOCOL REVIEW AND MONITORING SYSTEM

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Description: The Internal Scientific Protocol Review Committee, chaired by Dr. John A. Glaspy, was approved conditionally for early peer reevaluation during the last review. Two peer review evaluations occurred during the interim at the Parent Committee level. The first resulted in disapproval; the second awarded approval for the ISPRC process. The key elements at that time were a memo from the Chancellor indicating that all cancer-related research done at UCLA needed to have approval of the ISPRC for scientific merit prior to its submission to the IRB and evidence of more rigorous committee function. In addition, expanded committee membership, including a broader range of oncology disciplines and oncology research, had been instituted. A statistical checkoff had also been established to assure that all protocols have been seen by Cancer Center biostatisticians prior to their submission. The present application provides evidence that all protocols are being reapproved annually after re-review prior to the IRB submission. The committee now consists of 11 members representing biostatistics, cancer control, pharmacy, research nursing, and a spectrum of oncologists. For new protocol submissions, the committee uses a standard set of criteria. Most disapprovals over the past year are based upon one of the following: 1) insufficient scientific merit; 2) inadequate biostatistical analytical sections; 3) overlap with existing protocols without an obvious need for the secondary protocol; and 4) inability to support and carry out the protocol due to lack of adequate resources. With respect to the annual renewal, most disapprovals of those continuations were based upon one of the following: the rate of accrual is substantially lower than the originally stated target; the total accrual has met the originally stated target; or a report of the Quality Control Committee of any of the investigator's studies indicating that the research has not been conducted in a fashion that will lead to generation of correct and valid conclusions.