Statistical testing strategies for assessing treatment efficacy and marker accuracy in phase III trials

When a candidate predictive marker is available, but evidence on its predictive ability is not sufficiently reliable, all‐comers trials with marker stratification are frequently conducted. We propose a framework for planning and evaluating prospective testing strategies in confirmatory, phase III marker‐stratified clinical trials based on a natural assumption on heterogeneity of treatment effects across marker‐defined subpopulations, where weak rather than strong control is permitted for multiple population tests. For phase III marker‐stratified trials, it is expected that treatment efficacy is established in a particular patient population, possibly in a marker‐defined subpopulation, and that the marker accuracy is assessed when the marker is used to restrict the indication or labelling of the treatment to a marker‐based subpopulation, ie, assessment of the clinical validity of the marker. In this paper, we develop statistical testing strategies based on criteria that are explicitly designated to the marker assessment, including those examining treatment effects in marker‐negative patients. As existing and developed statistical testing strategies can assert treatment efficacy for either the overall patient population or the marker‐positive subpopulation, we also develop criteria for evaluating the operating characteristics of the statistical testing strategies based on the probabilities of asserting treatment efficacy across marker subpopulations. Numerical evaluations to compare the statistical testing strategies based on the developed criteria are provided.     

在位相空间中求解外力含时的受迫量子谐振子

运用广义线性量子变换理论 ,在位相空间中通过算子的代数运算求解外力含时的受迫谐振子 ,给出了演化算子、演化算子矩阵元和波函数的表示式 .     

我国高校文科学报的“当代化”论

高校文科学报的“当代化”是相对于时下盛行的“现代化”而言的。它是根据我国高校文科学报的发生及其发展历程的阶段性特征 ,以及“当代化”所蕴涵的人类文明进程的阶段性定位和“与时俱进”的时代性体现的科学内涵而提出来的。“当代化”具有现实性和求真性的鲜明特征 ,对于 2 1世纪我国高校文科学报的发展是一种求真务实的选择。     

律师在侦查阶段的诉讼地位和作用

律师在侦查阶段介入刑事诉讼不享有辩护人的独立诉讼地位 ,其法律行为具有法律帮助性质 ,主要为犯罪嫌疑人提供法律咨询 ,代理申诉、控告和为犯罪嫌疑人申请取保候审等。这种界定不仅有利于明确律师在侦查阶段的职责 ,也有利于打消认为律师介入侦查将带来太多负效应的顾虑。     

“大跃进”时期扫除文盲运动述论

1 95 8 - 1 960年 ,是新中国历史上的“大跃进”时期。在各行各业“大跃进”的历史条件下 ,也掀起了扫除文盲的“大跃进”运动。这一运动随形势发展 ,由兴到衰 ,经历了一个曲折的发展过程。在扫除文盲运动中 ,存在着严重的浮夸现象 ,但一些具体的做法也不无借鉴意义     

ispLSI1016在数字锁相环中的应用

讨论了采用ispLSI1 0 1 6构造数字锁相环的基本方法 ,并给出了分频器、相位比较器和吞脉冲计数器的相应的编码指令     

论正当防卫的限度

正当防卫的限度是在法学理论学界和司法实践中均有争议的问题 ,本文主要以 1997年《中华人民共和国刑法》关于正当防卫的规定来研究正当防卫的限度及特殊防卫权。这对如何认定特殊防卫权具有重要意义。     

失控的政府与政府的失控

凡立宪国家,不管民主政治发展的实际程度如何,一般都采用分权制衡的权力结构模式,即国家的立法、行政和司法权都由不同的机构来行使。二战后,权力结构的重心不断向行政方面转移,原有的三权分立制衡机制失衡,使得行政权失去应有的制约,导致出现失控的政府;失控的政府致使行政权呈现无限扩大的趋势,导致政府失控。政府失控所带来的政治和社会问题,成为现代各国的一大难题。     

非拓扑孤子模型的相变特征与袋常数的温度依赖性

本文计算了在有限温度和密度下非拓扑孤子模型的有效势;得到了袋常数对温度和化学势的依赖关系;分析了禁闭解除相变的特征.结果表明:该模型的禁闭解除相变为一级;相变特征的分析表明有退禁闭相与禁闭相的两相共存.     

A Two-dimensional Heat Transfer Model for Atmosphere-land System in the Lake-dominated Alaskan Arctic

1 Introduction Shallow tundra lakes are one of the dominating landscape features in the Alaskan Arctic. They typically cover 20% of the total area of the North Slope of Alaska, and up to about 40% in the coastal plain [1,2]. Many lakes are, in their entirety or in part, shallower than the maximum annual ice thickness, consequently, some ice freezes completely to the lake bottom, nevertheless, large areas of water are deeper than the maximum ice thickness and the ice remains afloat througho…