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.

随机临床试验 (RCT) 的样本量通常太小 因为先前对设计参数的估计是不准确的。 因此，一个 在 RCT 期间增加样本量的计算机化方法，无需 增加 D 级别对组织具有重要的商业应用 执行 RCTS。 该提案描述了 RCT 的一类新设计。 新设计 指定主要临床试验的一部分作为内部试点（IP） 学习。 样本量可以根据 IP 中的数据重新计算。 这 最终分析包括 IP 期间收集的数据。 拟议项目 将开发用于 IP 设计的原型软件程序。 第一阶段有三个目标： (a) 调查 IP 试验的二项式检验。 二项式表示分布 非独立样本均值和方差。 数值积分，已检查 为了模拟的准确性，将计算几种类型的尺寸和功率 IP 的。 (b) 通过正态分布的数值积分来确定 IP 阶段包含的计划样本的最佳比例。 (c) 编写一个演示计算机程序，使用该程序设计 IP-RCT 各种输入（例如，要重新计算的参数和最大 允许的样本量）。 在心血管疾病方面的应用将 强调。