DRUG MANAGEMENT SOFTWARE FOR NCI CLINICAL TRIALS

用于 NCI 临床试验的药物管理软件

• 批准号: 6054810
• 负责人: STEPHEN W BURKE
• 金额: $ 5万
• 依托单位: DDOTS, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-06-05 至 2000-02-04
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6054810
• 关键词: antineoplastics; cancer registry /resource; chemical registry /resource; computer data analysis; computer program /software; computer system design /evaluation; data management; mathematical model; neoplasm /cancer chemotherapy

National Cancer Institute (NCI)-supported research is primarily conducted by community cancer programs which are designated as NCI-funded Community Clinical Oncology Programs (CCOPs). The data management for NCI-CCOP research activity is not currently automated but rather depends upon an extensive and encumbering manual system to track patients through the protocol process. As a step to alleviate this labor intense system, DDOTS has developed a software program, "Cancer Research Environmental Data Information Tracking" (CREDIT) which is currently in use at several CCOPs to administrate patient records. During the PI's work with cancer centers in the development of this software, it became apparent that a major gap existed in their ability to monitor and track investigational drugs related to handling, inventory, and patient use. The specific goal of this project is to develop an algorithmic computer model that will inventory and track investigational drugs used in NCI sponsored clinical trials. This Phase I application has 3 specific aims: Development of a flow chart to map the overall conveyance of drugs, validation of the flow chart to ensure universal application to CCOPs, and the construct of a computer algorithm and preliminary software which correspond with the procedural processes in the NCI's "Drug Accountability and Drug Ordering" manuals. In Phase II, a comprehensive software package will be developed. PROPOSED COMMERCIAL APPLICATIONS Although this computer software model is being developed in conjunction with NCI-sponsored research programs, broad applicability exists for its use by all organizations conducting drug research, i.e., university hospitals, community hospitals, physician offices, pharmaceutical companies.

国家癌症研究所（NCI）支持的研究主要是进行 由被指定为NCI资助的社区的社区癌症计划 临床肿瘤学计划（CCOPS）。 NCI-CCOP的数据管理 研究活动目前不是自动化的，而是取决于 广泛而封闭的手动系统，以通过 协议过程。为了减轻这种劳动激烈的系统，DDOTS 已经开发了一个软件程序，“癌症研究环境数据 信息跟踪“（信用）目前正在使用几个CCOP 管理患者记录。在PI与癌症中心的合作期间 在该软件的开发中，很明显是一个主要差距 存在于其监测和跟踪研究药物的能力中 与处理，库存和患者使用有关。的具体目标 该项目是为了开发一种算法计算机模型 NCI赞助的临床中使用的库存和跟踪研究药物 试验。此I阶段应用具有3个具体目标：开发 流程图以绘制毒品的整体输送，验证流量 图表以确保通用到CCOP的通用应用，以及 计算机算法和初步软件，与 NCI的“药物责任和药物排序”中的程序过程 手册。在第二阶段，将开发一个综合的软件包。 拟议的商业应用 尽管该计算机软件模型正在共同开发 通过NCI赞助的研究计划，其广泛适用性 所有进行药物研究的组织的使用，即大学 医院，社区医院，医师办公室，药品 公司。