SOFTWARE FOR INTERNAL PILOT STUDIES FOR CLINICAL TRIALS

用于临床试验的内部试点研究软件

• 批准号: 3505435
• 负责人: Janet T. Wittes
• 金额: $ 5万
• 依托单位: STATISTICS COLLABORATIVE
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-09-30 至 1993-03-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3505435
• 关键词: computer program /software; computer simulation; computer system design /evaluation; computer system hardware; mathematics; statistics /biometry

Often sample sizes for randomized clinical trials (RCT) are too small because prior estimates of design parameters are inaccurate. Therefore, a computerized approach to increasing sample size during a RCT without increasing d-level has important commercial application for organizations that perform RCTS. This proposal describes a new class of designs for an RCT. The new design designates a portion of the main clinical trial as the internal pilot (IP) study. The sample size may be recalculated based on data from the IP. The final analysis includes data collected during the IP. The proposed project will develop prototype software programs for IP designs. Phase I has three aims: (a) To investigate operating characteristics of a binomial test for a IP trial. The binomial represents distributions with nonindependent sample mean and variance. Numerical integration, checked for accuracy by simulation, will calculate size and power for several types of IP's. (b) To determine by numerical integration for normal distributions the optimal proportion of the planned sample to include in the IP phase. (c) To write a demonstration computer program that designs an IP-RCT using a variety of inputs (e.g., parameters to be recalculated and maximum allowable sample size). Applications to cardiovascular disease will be stressed.

通常用于随机临床试验（RCT）的样本量太小 因为设计参数的先前估计值不准确。 因此， 在没有RCT期间增加样本量的计算机方法 不断增加的D级为组织具有重要的商业应用 执行RCT。 该建议描述了RCT的新设计类。 新设计 将主要临床试验的一部分指定为内部试验（IP） 学习。 样本量可以根据IP的数据重新计算。 这 最终分析包括在IP期间收集的数据。 拟议的项目 将开发用于IP设计的原型软件程序。 第一阶段的目标三个目标：（a）研究 IP试验的二项式测试。 二项式代表分布 非独立样本均值和方差。 数值集成，检查 为了通过模拟进行准确性，将计算几种类型的尺寸和功率 IP的。 （b）通过数值集成正常分布来确定 计划样本中包括在IP阶段中的最佳比例。 （c）编写一个使用IP-RCT的演示计算机程序 多种输入（例如，要重新计算的参数和最大的参数 允许样本量）。 对心血管疾病的申请将是 强调。