Investigational Drug

研究药物

• 批准号: 8933273
• 负责人: DONALD L TRUMP
• 金额: $ 4.66万
• 依托单位: ROSWELL PARK CANCER INSTITUTE CORP
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-26 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8933273
• 关键词: Accountability; Adverse event; Amendment; Award; Budgets; Cancer Center Support Grant; Cancer Therapy Evaluation Program; Clinical Data; Clinical Protocols; Clinical Research; Clinical Services; Computerized Medical Record; Consultations; Counseling; Doctor of Pharmacy; Documentation; Dose-Limiting; Drug Compounding; Enrollment; Ensure; Foundations; Funding; Industry; Institutional Review Boards; Instruction; Investigational Drugs; Monitor; Pamphlets; Patient Monitoring; Patients; Peer Review; Pharmaceutical Preparations; Pharmacists; Pharmacologic Substance; Pharmacy facility; Phase; Play; Preparation; Process; Reporting; Research; Research Personnel; Resources; Role; Roswell Park Cancer Institute; Services; Source; Sterility; Time; Toxic effect; United States National Institutes of Health; Update; data management; dosage; driving force; meetings; member; phase 1 study; programs; research study; screening

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).

由药学博士 Barbara Todaro 领导的研究药物服务中心 (IDS) 在 RPCI 研究。 IDS 工作人员负责研究药物管理的各个方面， 包括问责、订购、接收、销毁、退货、适当储存和分发。入侵检测系统 药剂师为参加临床研究的患者提供药物咨询。他们还 在研究筛选中为患者提供药物协调，这已记录在 电子病历（EMR）。研究的数量和复杂性，尤其是第一阶段 研究，是药学系和临床医学系创建 IDS 的驱动力 协议和数据管理 (CPDM) 办公室。 需要八 (8) 个 FTE 来支持所有 RPCI 临床研究。 IDS 人员的职责 包括对 SRC 和 IRB 提交的研究审查、修订审查、修订研究者审查 小册子、研究实施、配药和无菌产品制备以及临床服务，例如 药物审查和患者咨询。 IDS 工作人员还参与实施 RPCI 临床研究网络中研究者发起的研究。 IDS 工作人员提供专家 使用药品的每项临床研究的咨询。 Todaro 博士是第一阶段委员会的联合主席，为 35 个第一阶段项目提供了咨询 研究者在上一个奖项期间发起的研究。在托达罗博士的指导下，报告 不良事件、剂量限制毒性和第一阶段患者监测的流程已更新为 及时向机构审查委员会（IRB）提供必要的关键信息。 在提交本报告时，IDS 负责 300 多个研究项目，其中 150 80 项临床研究的研究药物或项目。 IDS 成员参加所有研究启动 会议。 2012年共召开临床研究实施会议53次。 IDS 资源的利用优先顺序如下： 同行评审资助的资源优先使用 RPCI CCSG 成员；第二优先考虑非同行评审资助的 CCSG 成员；非会员的第三优先权 和学术合作者；最后优先考虑外部用户。报告期内，IDS 为来自 6 个研究项目的 28 名成员提供服务，经同行评审的 CCSG 成员利用率为 63% 资金。 CCSG 占拟议预算总额的 3%。此应用程序寻求 0.14 FTE 支持 主任，由机构来源和研究赞助商提供人员配置支持 （NIH/CTEP、行业、基金会）。