Investigational Drug Services

研究药物服务

基本信息

批准号：
7714437
负责人：
Barbara Todaro
金额：
$ 2.8万
依托单位：
ROSWELL PARK CANCER INSTITUTE CORP
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-07-28 至 2013-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7714437
关键词：
Accountability Accounting Adverse event Area Beds Biological Products Body Fluids Bupropion Calcitriol Cancer Center Cancer Center Support Grant Category Rating Scale Class Clinical Research Clinical Trials Complex Consent Consult Consultations Discipline of Nursing Doctor of Pharmacy Doctor of Philosophy Dosage Forms Dose Drug Kinetics Drug Storage Education Enrollment Ensure Equipment and supply inventories Facility Construction Funding Category Floor Foundations Future Goals Grant Hospitals Housing Human Resources Industry Institutes Intravenous Investigational Drugs Investigator-Initiated Research Laboratories Monitor Numbers Outpatients Participant Patient Agents Patients Performance Pharmaceutical Cares Pharmaceutical Preparations Pharmaceutical Services Pharmacodynamics Pharmacologic Substance Pharmacy facility Phase Play Police Policies Preparation Procedures Process Protocols documentation Recruitment Activity Regulation Reporting Research Research Personnel Research Support Resource Sharing Resources Review Committee Role Safety Sampling Schedule Science Services Site Source Sterility Time Tissue Sample Validation Work Workplace Writing chemotherapy clinical research site driving force drug development foot member patient safety programs research study size stem tetrathiomolybdate

项目摘要

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.

研究代理人的分配和药物问责责任对研究至关重要过程。研究者发起的研究的数量和复杂性是背后的驱动力药房和临床研究部创建研究药服务（IDS）服务。 IDS为每个飞行员，I阶段和II阶段研究者提供的专家药物咨询研究，利用药品。 Pharmd的Barbara Todaro是IDS主管；在2006年，她在提交SRC之前，请先咨询31个研究者发起的研究。 PharmD的Alison Meagher是第一阶段委员会的助理主任。在Meagher博士的指导下，报告过程的对I期患者的不良事件和监测已简化。在此提交时，IDS负责43个单独研究人员的72个库存项目研究。 IDS的成员参加了所有学习启动会议，2006年有15个研究人员发起的研究的实施会议。 IDS与RPCI调查人员密切合作，以确保适当的药物和剂型表需要复杂准备程序的研究药物。例子包括涉及的研究静脉内钙化，安非他酮和四酚余生，在几种中得到多个赠款的支持 CCSG程序。 3.3 FTE需要支持在RPCI方案特定研究下的所有相关临床试验支持。该应用程序寻求0.3FTE支持此功能，并提供额外的支持机构来源以及研究赞助商（NIH/CTEP，行业，基金会）。请求$ 33,281的CCSG支持。