CORE--INVESTIGATIONAL DRUG SERVICES

核心——药物研究服务

基本信息

批准号：
6989581
负责人：
ROWENA N SCHWARTZ
金额：
$ 7.27万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-09-22 至 2009-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6989581
关键词：
antineoplastics biomedical facility drug abuse information system drug design /synthesis /production drug quality /standard neoplasm /cancer chemotherapy pharmacy pharmacy administration training

项目摘要

UPCI Investigation Drug Service (IDS) is directed by Rowena Schwartz, Pharm.D., BCOP and managed by Carol L. Matthews, R.Ph. The UPCI IDS oversees all pharmacy procedures and processes for IDS and clinical sites where UPCI sponsored studies are implemented. The service is responsible for coordinating and managing the investigational drug inventory, storage, distribution, and record keeping for UPCI clinical research studies. The IDS has moved into the Hillman Cancer Center and three additional UPMC cancer centers have opened in the Western Pennsylvania region increasing off site locations requiring additional efforts and time for implementation and ongoing coordination and monitoring of studies. The IDS will be working closely with the UPCI efforts in the recently funded NCI grant for overcoming barriers to participation in early clinical trials at community-based locations. The IDS will continue to facilitate the conduct of early phase clinical trials throughout the network sites by developing strategies for drug preparation and delivery in sites that are not currently involved in clinical trials. All protocols are reviewed by Ms. Matthews early in the developmental phase to identify any IDS related issues including the pharmaceutical and clinical pharmacy requirements. This review includes an assessment of drug handling issues, implementation requirements, development of procedures for drug preparation at each treatment site and study related drug costs on the impact of protocol development and implementation. The IDS is also responsible for the education of pharmacists throughout the network who will be handling the drugs or agents for each protocol. The IDS is responsible for working with new clinical sites to develop appropriate processes for drug handling and preparation. The IDS is responsible for drug management, investigational drug supply including development of protocol specific pharmacy procedures for drug management that can be adapted to each participating clinical site, development and/or adaptation of protocol specific guidelines for written medication or medications used in the clinical studies, maintaining all investigational medications in secured areas of clinical sites, maintaining drug accountability records for invesfigational medications, coordination of medication distribution of the clinical sites involved in clinical studies, and routine quality assurance of drug handling. Quality assurance includes monitoring of drug accountability records, a coding system, and a form to calculate dose for specific protocols. The IDS will provide important infrastructure support for the coordination of studies within the UPMC cancer's network and will work with each clinical site to develop the appropriate implementation plan on a protocol by protocol basis.

UPCI 药物调查服务 (IDS) 由药学博士、BCOP Rowena Schwartz 指导，由 R.Ph. Carol L. Matthews 管理。 UPCI IDS 监督 IDS 的所有药房程序和流程以及实施 UPCI 赞助研究的临床中心。该服务负责协调和管理 UPCI 临床研究的研究药物库存、存储、分发和记录保存。 IDS 已迁入 Hillman 癌症中心，并且在宾夕法尼亚州西部地区另外开设了三个 UPMC 癌症中心，增加了场外地点，需要额外的努力和时间来实施以及持续协调和监测研究。 IDS 将在最近资助的 NCI 赠款中与 UPCI 密切合作，以克服障碍参与社区地点的早期临床试验。 IDS 将通过在目前未参与临床试验的站点制定药物制备和交付策略，继续促进整个网络站点中早期临床试验的进行。所有协议均由 Matthews 女士在开发阶段早期进行审核，以确定任何 IDS 相关问题，包括制药和临床药学要求。该审查包括对药物处理问题、实施要求、每个治疗地点药物制备程序的制定以及研究相关药物成本对方案制定和实施影响的评估。 IDS 还负责对整个网络中负责处理每个协议的药物或制剂的药剂师进行教育。 IDS 负责与新的临床中心合作开发适当的药物处理和制备过程。 IDS 负责药物管理、研究药物供应，包括制定可适应每个参与临床中心的药物管理方案特定药房程序、制定和/或调整书面药物或临床研究中使用的药物的方案特定指南，将所有研究药物保存在临床中心的安全区域，维护研究药物的药物责任记录，协调参与临床研究的临床中心的药物分配以及常规质量保证毒品处理。质量保证包括监测药物责任记录、编码系统和计算特定方案剂量的表格。 IDS 将为协调 UPMC 癌症网络内的研究提供重要的基础设施支持，并将与每个临床中心合作，根据方案制定适当的实施计划。