The Investigational Drug Service (IDS), directed by Barbara Todaro, PharmD, plays a critical role in RPCI research. IDS staff members are responsible for all aspects of investigational drug management, including accountability, ordering, receiving, destruction, returns, proper storage and dispensing. IDS pharmacists provide medication counseling for patients enrolled in clinical research studies. They also provide medication reconciliation for patients in screening for a research study, and this is documented, in the electronic medical record (EMR). The number and complexity of research studies, especially Phase 1 studies, were the driving forces behind the creation of IDS by the Department of Pharmacy and the Clinical Protocol and Data Management (CPDM) office. Eight (8) FTEs are required to support all RPCI clinical research studies. Responsibilities of IDS staff include study review for SRC and IRB submission, amendment review, review of amended investigator brochures, study implementation, dispensing and sterile products preparation, and clinical services such as medication review and patient counseling. An IDS staff member is also involved with implementation of Investigator-Initiated studies in the RPCI Clinical Research Network. IDS staff members provide expert consultation for each clinical research study utilizing pharmaceutical products. Dr. Todaro is the Co-Chair of the Phase 1 Committee and has provided consultation for thirty-five Phase I Investigator-Initiated studies during the previous award period. Under Dr. Todaro's direction, the reporting processes for adverse events, dose limiting toxicities and phase 1 patient monitoring have been updated to provide the Institutional Review Board (IRB) with necessary critical information in a timely manner. At the time of this submission, IDS was responsible for more than 300 investigational items, with 150 investigational drugs or items for 80 clinical research studies. A member of IDS attends all study initiation meetings. There were 53 implementation meetings for clinical research studies in 2012. Utilization of IDS resources is prioritized as follows: First priority for use is given to peer-review-funded RPCI CCSG members;second priority to non-peer-review-funded CCSG members;third priority to nonmembers and academic collaborators;and last priority to external users. During the reporting period, IDS served 28 members from 6 research programs, with 63% utilization by CCSG members with peer reviewed funding. The CCSG makes up 3% of the overall proposed budget. This application seeks 0.14 FTE support for the Director, with staffing support to be provided by institutional sources as well as study sponsors (NIH/CTEP, industry, foundations).
Accurate drug preparation and accountability, as well as dosage dispensing, are essential to ensuring scientifically valid clinical research. IDS is a centralized specialized resource that performs a full scope of activities to assist investigators with medication preparation, distribution, monitoring, and documentation to facilitate effective and efficient conduct of clinical research studies.
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