DESIGN POWER SOFTWARE FOR CLINICAL STUDIES

第一阶段SBIR建议涉及计算样本量的PC软件， 生物医学研究设计的统计功效。 在第一阶段， 该计划将实现两个新的模拟设计的时间， 事件研究：Halpern和Brown [1987]的一种方法， 生存数据，可能取自已发表的文章，以估计样本 一项新研究的大小和功效，以及我们为研究开发的方法， 在每次更新时重新分析累积的存活数据。 一期 还将包括重复测量的功效计算（纵向） 研究具有持续的结果。 这些都不是当前可用的 设计软件 我们的第二阶段包将包括简单，图形 探索设计特征之间的权衡，计算广泛的 一系列临床和流行病学设计以及针对具体情况的建议 对于预期用户（例如，与研究设计相关的医生或 统计学家）。 最近对该产品类别的评论表明， 医疗、医疗器械、医疗器械、 环境和工业研究，但目前的状态是 不满意。 我们研究了这些评论和软件，并认为 我们提出的产品信息量更大，更全面， 吸引人.

This Phase I SBIR proposal concerns PC software to compute sample size and statistical power for the design of biomedical studies. For Phase I, our program will implement two novel simulations for the design of time-to- event studies: a method of Halpern and Brown [1987] that uses existing survival data, perhaps taken from published articles, to estimate sample size and power for a new study, and a method we developed for studies in which accumulating survival data are re-analyzed at each update. Phase I will also include a power calculation for repeated measures (longitudinal) studies with continuous outcomes. None of these is available in current design software. Our Phase II package will include easy, graphical exploration of tradeoffs between design features, calculations for a wide range of clinical and epidemiological designs and context-sensitive advice to the intended user (e.g., physician concerned with study design or statistician). Recent reviews of this product category suggest a substantial demand for comprehensive, flexible design software for medical, environmental and industrial studies but that the current state is unsatisfactory. We have studied these reviews and the software and believe that our proposed product is more informative, more comprehensive, and more attractive.