The dispensing and drug accountability responsibilities of investigational agents are critical to the research process. The number and complexity of investigator-initiated studies was the driving force behind the creation of the Investigational Drug Service (IDS) by the Department of Pharmacy and Clinical Research Services. IDS provides expert pharmaceutical consultation for each pilot, phase I and II investigator-initiated research study, utilizing pharmaceutical products. Barbara Todaro, PharmD, is the IDS Director;in 2006, she consulted on thirty-one investigator-initiated studies prior to SRC submission. Alison Meagher, PharmD, is the assistant director of the Phase I committee. Under Dr. Meagher's direction the reporting processes for adverse events and monitoring of phase I patients has been streamlined. At the time of this submission, IDS was responsible for 72 inventory items for 43 separate investigatorinitiated studies. A member of IDS attends all study initiation meetings and in 2006, there were 15 implementation meetings for investigator-initiated research studies. IDS works closely with RPCI investigators to ensure appropriate drug and dosage forms are available for investigational drugs requiring complex preparation procedures. Examples include studies involving intravenous calcitriol, bupropion and tetrathiomolybdate, which are supported by multiple grants in several CCSG programs. 3.3 FTEs are required to support all relevant clinical trials that are under the RPCI protocol-specific research support. This application seeks 0.3FTE support for this function, with additional support to be provided by institutional sources as well as study sponsors (NIH/CTEP, industry, foundations). $33,281 in CCSG support is requested.
Showing the most recent 10 out of 1555 publications
