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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA016056-36
Application #
8375984
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
2014-04-30
Budget Start
2012-05-01
Budget End
2013-04-30
Support Year
36
Fiscal Year
2012
Total Cost
$70,209
Indirect Cost
$27,793
Name
Roswell Park Cancer Institute Corp
Department
Type
DUNS #
824771034
City
Buffalo
State
NY
Country
United States
Zip Code
14263
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