Research Pharmacy

研究药房

基本信息

批准号：
10357809
负责人：
Michael Patrick Kane
金额：
$ 7.39万
依托单位：
RBHS -CANCER INSTITUTE OF NEW JERSEY
依托单位国家：
美国
项目类别：
财政年份：
1997
资助国家：
美国
起止时间：
1997-03-01 至 2023-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10357809
关键词：
Accountability Basic Science Cancer Center Cancer Center Support Grant Cancer Institute of New Jersey Clinical Clinical Trials Computer software Computerized Medical Record Consultations Data Development Dose Drug Interactions Electronic Health Record Eligibility Determination Enrollment Ensure Equipment and supply inventories Formulation Guidelines Health Insurance Portability and Accountability Act Human Informatics Informed Consent Institutional Review Boards Investigation Investigational Drugs Investigational New Drug Application Laboratories Leadership Maintenance Malignant Neoplasms Methods Modeling Modification National Cancer Institute New Agents Outcome Patients Pharmaceutical Preparations Pharmacists Pharmacologic Substance Pharmacy facility Policies Preparation Procedures Protocols documentation Publications Quality of Care Randomized Research Research Personnel Research Subjects Resource Sharing Role Safety Science Secure Self Administration Services Testing Therapeutic Therapeutic Agents Toxic effect Translational Research Vial device base cancer clinical trial cancer therapy clinical trial participant compliance behavior data mining federal policy high standard human subject improved innovation interest investigator-initiated trial laboratory experiment member patient population phase I trial programs quality assurance

项目摘要

RESEARCH PHARMACY SHARED RESOURCE PROJECT SUMMARY/ABSTRACT Cancer clinical trials advance treatment paradigms by testing agents for potentially greater efficacy or lesser toxicity. The Research Pharmacy shared resource provides expertise in investigational and commercially available cancer therapeutic agents and ensures a uniformly high standard of safe, accurate treatment for CINJ patients with cancer participating in clinical trials; these services are crucial to one of the central strategic initiatives of the cancer center: high quality, innovative translational research. The Research Pharmacy shared resource of Rutgers Cancer Institute of New Jersey (CINJ) is a Cancer Center managed shared resource whose purpose is to support CINJ members who conduct rigorously reviewed research with investigational agents in human subjects by providing an efficient, centralized service of extraordinary quality. Since the last CCSG submission, Research Pharmacy is increasingly called upon for consultation in the planning of clinical projects. CINJ investigators seek advice on issues regarding drug interactions, drug sequencing for multi-agent trials, dose modifications, formulation of compounds, identification of compounds for use, and consultations regarding Investigational New Drug (IND) applications. Additionally, our Informatics Pharmacist performs various data mining of our electronic medical record (EMR) to assist investigators in selecting and modeling clinical trials based on our patient population. These efforts are guided by policies and procedures ensuring compliance with HIPAA and institutional review board (IRB) requirements.

研究药房共享资源项目摘要/摘要癌症临床试验通过测试可能更大的功效或更小的测试剂来提高治疗范例毒性。研究药房共享资源提供了研究和商业上的专业知识可用的癌症治疗剂，并确保统一的安全，准确的治疗标准 CINJ参加临床试验的癌症患者；这些服务对于中心战略之一至关重要癌症中心的举措：高质量，创新的翻译研究。研究药房共享新泽西州罗格斯癌症研究所（CINJ）是一种癌症中心管理共享资源，其目的是支持严格进行CINJ成员通过提供高效的集中服务，与人类受试者的研究代理一起审查了研究质量非凡。自上次CCSG提交以来，越来越多地要求研究药房在计划临床项目。 CINJ调查人员寻求有关药物相互作用的问题的建议测序多代理试验，剂量修饰，化合物的制定，鉴定化合物用于使用和有关调查新药（IND）应用的咨询。此外，我们的信息学药剂师对我们的电子病历（EMR）进行各种数据挖掘，以协助研究人员根据我们的患者群体选择和建模临床试验。这些努力以政策为指导，确保遵守HIPAA和机构审查委员会（IRB）要求的程序。