Pharmaceutical Research Center

PROJECT SUMMARY / ABSTRACT The Pharmaceutical Research Center (PRC) operates within the University of Wisconsin Health System (UW Health); our mission is to ensure that drug research protocols, including those of The University of Wisconsin Carbone Cancer Center (UWCCC), proceed optimally through established medication use systems and in accordance with all federal, state, institutional, and sponsor regulations governing clinical research. For each clinical drug trial, PRC establishes procedure for overall study drug management; develops protocol-specific workflow; creates drug monograph(s) for health care providers; creates the order set; provides quality assurance audits; and reviews all protocol amendments. To support the unique needs of UWCCC investigators, PRC manages gene therapy and hazardous oncology drug trials; provides accurate response to drug interaction inquiries from investigators; and verifies authorized prescriber status in accordance with NCI requirements. During the current Cancer Center Support Grant (CCSG) funding cycle, PRC has served 49 unique UWCCC program members across all six programs, enabled UWCCC investigators to implement 137 peer-reviewed clinical drug trials and provided study drug oversight for an average of 75 new cancer-focused clinical trials each year. PRC has also participated in the design process for the research pharmacy to be located within Eastpark Medical Center, which will house UWCCC clinics. 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 drug 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 and regional partner locations, and to extend clinical cancer research across Wisconsin. Strategic initiatives of PRC to be completed within this funding period include: 1) complete implementation of an electronic investigational drug management system to improve efficiency, data quality, uniformity, and compliance; 2) implement research pharmacy services at Eastpark Medical Center to support clinical trials; and 3) complete a gap analysis of our services and quality assurance program with the NCI Auditing best practice standards. 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, in strong alignment with the UWCCC mission to translate new therapies to clinical application.