Software for Cost Effective Clinical Trial Design

描述：（申请人摘要中的逐字记录）：长期目标 本项目的目的是开发软件，以方便设计成本 有效的临床试验。1999年，制药业和国家卫生研究院 超过230亿美元用于临床试验。临床试验设计的发展 理论，并在优化算法开辟了更多的可能性 具有成本效益的设计，可以在较短的时间内以较低的总成本执行 时间段和/或需要较少的患者。拟议的费用制度 有效试验（SCET）将是一个软件包，用于指导试验设计者 通过比较功效、样本量要求和成本， 替代试验设计。这些方法在整个医疗过程中使用不足 研究，但特别适用于相对较短的试验 治疗方案和快速确定终点，如许多癌症 治疗试验。第一阶段项目的具体目标是建立一个 软件开发计划，执行需求分析， 系统需求文档，设计整体系统架构， 设计用户界面并为系统制定功能规格， 并对用户界面进行原型化。 拟定商业应用： 这个软件系统的潜在市场包括几乎所有的制药公司 在世界上（每个多个许可证），每一个生物技术公司参与临床试验，每一个 参与临床试验设计或实施的合同研究组织，协调 NIH申办的多中心临床试验中心，单个大学研究者 进行临床试验的人，设计临床试验的个体生物统计顾问，以及 从事动物研究的农业企业和研究人员。

DESCRIPTION: (Verbatim from the Applicant's Abstract):The long-term objective of this project is to develop software to facilitate the design of cost effective clinical trials. In 1999, the pharmaceutical industry and NIH spent more than $23 billion on clinical trials. Developments in clinical trial design theory, and in optimization algorithms have opened possibilities for more cost-effective designs that can be executed for lower total cost, over shorter periods of time and / or requiring fewer patients. The proposed System for Cost Effective Trials (SCET) will be a software package to guide the trial designer through comparisons of the power, sample size requirements, and cost of alternate trial designs. These methods are under-used throughout medical research, but are particularly applicable to trials with relatively short treatment regimens and rapid ascertainment of endpoints, such as many cancer treatment trials. The specific aims of this phase I project are to create the software development plan, to perform the requirements analysis, to produce the system requirements document, to design the overall system architecture, to design the user interface and produce functional specifications for the system, and to prototype the user interface. PROPOSED COMMERCIAL APPLICATION: The potential market for this software system includes virtually every pharmaceutical company in the world (multiple licenses to each), every biotech company involved in clinical trials, every contract research organization involved in the design or conduct of clinical trials, coordinating centers of NIH-sponsored multi-center clinical trials, individual university-based investigators who conduct clinical trials, individual biostatistical consultants who design clinical trials, and agricultural businesses and researchers that conduct animal research.