The University of Pittsburgh Cancer Institute Protocol Review Committee oversees the responsibilities of the University of Pittsburgh Cancer Institute with regard to review and monitoring of all cancer research conducted within the University of Pittsburgh Medical Center. The University of Pittsburgh Institutional Review Board (IRB) mandates that all clinical cancer protocols conducted in the Medical Center and in all affiliated institutions be reviewed and approved by the UPCI Protocol Review Committee prior to IRB approval and implementation. Dr. Donald Trump, Deputy Center Director for Clinical Investigations, oversees the activities of the Protocol Review Committee. He is assisted in these activities by Janie Hofacker, R.N., Regulatory Affairs Coordinator, and Lyn Robertson, R.N., Director of UPCI Clinical Research Services. The protocol review process is conducted by two subcommittees meeting on alternate weeks in order to facilitate clinical protocol review in concert and in advance of the IRB meetings. The two subcommittees are composed of a total of 34 individuals representing Clinical Investigation, Biological Therapeutics, Molecular Pharmacology, Behavioral Medicine, Nursing, Pharmacy, Biostatistics, Hematology/Oncology, Surgical Oncology, Radiation Oncology, Community Medical Oncology and Physical Resource Management. In response to the prior review, which recommended early peer re- evaluation, the Protocol Review Committee performed re-evaluations in August and December of 1996 that resulted in full approval of the UPCI Protocol Review and Monitoring System. At the time of the last competitive review, the conditional approval was based on the absence of a system of automatic protocol closure once target accrual had been met, the need for more stringent criteria to close slowly accruing protocols, the need to standardize statistical input into protocols, and the absence of a clear protocol priority list. In response to those criticisms, beginning in March 1996, the University of Pittsburgh Cancer Institute implemented a computer-based system for closure of protocols as target accrual was met, and a system for defining slow accruing protocols for early closure. As a formal requirement, biostatistical input was initiated and priority lists were implemented by requiring at the time of the Protocol Review Committee's initial review, a definite assessment of where an individual study was placed on the Protocol Priority List of the disease-oriented programs. For these reasons, the Protocol Review and Monitoring System was fully approved in December 1996.
Showing the most recent 10 out of 1187 publications
