Pharmaceutical Research Center Shared Resource

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PROJECT SUMMARY/ABSTRACT The Pharmaceutical Research Center (PRC) operates within the University of Wisconsin Health System (UW Health) and is responsible for the safe and ethical provision of investigational study medications to research subjects enrolled in all clinical drug trials within our hospitals and clinics, including those of The University of Wisconsin Carbone Cancer Center (UWCCC). The mission of the PRC is to ensure that drug research protocols proceed optimally through established medication use systems and in accordance with all federal, state, institutional, and sponsor regulations governing clinical research. PRC services enhance regulatory rigor and subject safety while facilitating the conduct of clinical drug research within our academic medical center. For each clinical drug trial, PRC establishes study drug handling, distribution, preparation, and destruction procedures; develops a protocol specific workflow; creates an investigational drug monograph(s) for health care providers; educates health care staff regarding protocol procedures; creates the physician orders set; manages drug inventory and accountability; prepares drugs and/or monitors drug preparation; monitors drug expiration and retest dates; provides quality assurance audits; and reviews all protocol amendments. In addition, PRC provides services that are specifically tailored to the unique needs of UWCCC investigators. For example, PRC manages trials involving gene therapy and hazardous oncology drugs; provides accurate response to drug interaction inquiries from investigators and care providers; and verifies authorized prescriber status in accordance with NCI requirements. During the current CCSG funding cycle, PRC has enabled UWCCC investigators to implement 170 peer-reviewed clinical drug trials and has provided study drug oversight for an average of 200 cancer focused clinical trials each year. PRC strives to refine, enhance and/or expand our services to meet the evolving needs of the UWCCC research faculty and our research subjects, while operating in rapidly changing healthcare and regulatory environments. Our specific aims are to: 1) provide detailed protocol review and feasibility assessment of each UWCCC protocol; 2) ensure all UWCCC study protocols comply with Good Clinical Practice (GCP) standards; 3) provide services essential to the advancement of clinical cancer research; and 4) facilitate clinical drug research within UW Health satellite pharmacies that extend clinical cancer research across our catchment area. Base funding from the CCSG allows PRC leaders to serve as members of the UWCCC scientific leadership team to ensure PRC is well positioned to meet the evolving needs of UWCCC investigators and thereby enhance the ability of our members to enroll patients onto investigator initiated clinical studies that ultimately will improve outcomes for our patients and society.