Software for Cost Effective Clinical Trial Design

描述：(逐字摘自申请者摘要)：长期目标 这个项目的目的是开发软件，方便成本的设计 有效的临床试验。1999年，制药业和NIH花费了 超过230亿美元用于临床试验。临床试验设计的进展 理论，在优化算法中，为更多的 成本效益高的设计，可在更短的时间内以更低的总成本执行 时间段和/或需要的病人较少。拟议的成本核算系统 有效试验(SCET)将是指导试验设计者的软件包 通过对功率、样本量要求和成本的比较 另一种试验设计。这些方法在整个医疗过程中都没有得到充分的使用 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，例如许多癌症 治疗试验。这个第一阶段项目的具体目标是创建 软件开发计划，执行需求分析，生成 系统需求文档，以设计总体系统架构，以 为系统设计用户界面并制作功能规格书， 并制作用户界面的原型。 建议的商业应用： 该软件系统的潜在市场包括几乎所有的制药公司 在世界上(每个公司都有多个许可证)，参与临床试验的每一家生物技术公司，每一家 参与临床试验设计或实施的合同研究组织，协调 美国国立卫生研究院赞助的多中心临床试验中心，个别大学研究人员 进行临床试验的人，设计临床试验的个人生物统计顾问，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.