Issues in applying recent CPMP ‘Points to Consider’ and FDA guidance documents with biostatistical implications

The International Conference on Harmonisation guideline ‘Statistical Principles for Clinical Trials’ was adopted by the Committee for Proprietary Medicinal Products (CPMP) in March 1998, and consequently is operational in Europe. Since then more detailed guidance on selected topics has been issued by the CPMP in the form of ‘Points to Consider’ documents. The intent of these was to give guidance particularly to non‐statistical reviewers within regulatory authorities, although of course they also provide a good source of information for pharmaceutical industry statisticians. In addition, the Food and Drug Administration has recently issued a draft guideline on data monitoring committees. In November 2002 a one‐day discussion forum was held in London by Statisticians in the Pharmaceutical Industry (PSI). The aim of the meeting was to discuss how statisticians were responding to some of the issues covered in these new guidelines, and to document consensus views where they existed. The forum was attended by industry, academic and regulatory statisticians. This paper outlines the questions raised, resulting discussions and consensus views reached. It is clear from the guidelines and discussions at the workshop that the statistical analysis strategy must be planned during the design phase of a clinical trial and carefully documented. Once the study is complete the analysis strategy should be thoughtfully executed and the findings reported. Copyright © 2003 John Wiley & Sons, Ltd.     

Estimation of dependence between paired correlated failure times in the presence of covariate measurement error

Summary. In many biomedical studies, covariates are subject to measurement error. Although it is well known that the regression coefficients estimators can be substantially biased if the measurement error is not accommodated, there has been little study of the effect of covariate measurement error on the estimation of the dependence between bivariate failure times. We show that the dependence parameter estimator in the Clayton–Oakes model can be considerably biased if the measurement error in the covariate is not accommodated. In contrast with the typical bias towards the null for marginal regression coefficients, the dependence parameter can be biased in either direction. We introduce a bias reduction technique for the bivariate survival function in copula models while assuming an additive measurement error model and replicated measurement for the covariates, and we study the large and small sample properties of the dependence parameter estimator proposed.     

Improved model selection criteria for SETAR time series models

The purpose of this paper is threefold. First, we obtain the asymptotic properties of the modified model selection criteria proposed by Hurvich et al. (1990. Improved estimators of Kullback-Leibler information for autoregressive model selection in small samples. Biometrika 77, 709–719) for autoregressive models. Second, we provide some highlights on the better performance of this modified criteria. Third, we extend the modification introduced by these authors to model selection criteria commonly used in the class of self-exciting threshold autoregressive (SETAR) time series models. We show the improvements of the modified criteria in their finite sample performance. In particular, for small and medium sample size the frequency of selecting the true model improves for the consistent criteria and the root mean square error (RMSE) of prediction improves for the efficient criteria. These results are illustrated via simulation with SETAR models in which we assume that the threshold and the parameters are unknown.     

基于旅西日本游客旅游选择行为的西安旅游市场分析

根据在全国六大旅游热点城市所做的旅游市场调查的数据结果，对旅西日本游客的旅游选择行为进行了研究，同时进一步有针对性地对西安日本客源市场进行了SWOT分析，在此基础上，对西安旅游业的发展提出了相关对策建议。     

基于TOPSIS理论的企业供应商选择应用

供应链管理已经成为企业获取竞争优势的手段,供应商选择是企业构建供应链体系的重要内容。TOPSIS是一种简单易行的多因素选优的理论方法,它利用熵来确定评价指标的权重,避免了在确定评价指标权重时主观因素的影响,为公司的供应商选择提供了一种科学、量化、高效的手段。文章回顾了供应商选择的理论现状,介绍了TOPSIS理论模型和利用它进行供应商选择的步骤,通过对典型企业的深入调研,阐述了该企业如何应用TOPSIS进行供应商选择。     

利用光敏核不育性进行水稻轮回选择的程序探讨

本文对利用光敏核不育性进行水稻轮回选择进行了探讨。提出基本轮回选择方案和综合轮回选择方案。基本轮回选择方案是以一个光敏核不育材料为母本与多个亲本组配构成轮回选择的综合群体,而其后按常规轮回选择法进行育种的方案。综合轮回选择方案是以两个或两个以上的光敏核不育材料作为母体与多个亲本组配,在 F_2代群体中不同质源的优良植株相互交配构成综合群体,其后按基本方案进行的轮回选择。     

网络文学的当下可能性

本文根据当前对网络文学的定义 ,从三个方面分析说明了网络文学出现的当下可能性。一是网络媒介的出现引起文学载体和传播方式的变化 ,形成了自己的文学群落 ,培养了一大批文学爱好者的文学受众。二是作为写作的网络文学 ,实际上是对当前出现的知识霸权和文学生产麦当劳化的反拨 ,使文学向着自由无功利和审美愉悦性传统回归。三是网络文学作为一种题材 ,与传统文学无本质上的区别 ,是网络出现后形成的一种特定群体生活状态的反映 ,从而在题材选取 ,主题表现及表现技巧上具有其独特性。     

信息不对称与人的经济行为

信息不对称及其经济效应是信息经济学研究的中心问题,本文依据信息经济学和行为科学理论,从现实经济生活出发,系统地阐述了信息不对称的内涵,论证了信息不对称的必然性,探讨了信息不对称条件下交易双方的经济行为,提出了信息不对称条件下卖方(或代理方)违规败德行为的函数式,最后讨论了信息不对称造成的经济后果,提出了解决这一问题的思路。     

存在战略购买需求的定价、供给、机制选择和配给研究

本文研究存在战略购买需求的易逝资产销售策略问题。垄断厂商基于利润最大化目标确定易逝资产定价、供给、机制选择和配给策略,战略消费者通过锚定预期价格安排战略购买时机。不同于通常基于效用理论研究定价的思路,本文首先基于锚定效应和跨期价格均衡思想探寻不同战略等待购买规模的市场预期需求曲线和动静态定价区域;其次在众多预期需求曲线中寻找市场有效定价前沿（即有效预期需求曲线）;再次在利润曲面上找出与有效定价前沿对应的容量扩展线（即最大利润曲线）;最后沿容量扩展线和有效定价前沿搜寻最大期望利润及相应策略。研究表明,消费者保留价异质和需求不确定性是动态定价和战略购买存在的根本原因;市场在不同战略等待购买规模状态拥有不同预期需求曲线,最大战略等待购买规模状态预期需求曲线是市场有效定价前沿。动静态定价机制各有其所适用的容量和价格空间,消费者保留价水平和战略消费者规模决定动态定价空间大小,随机需求分布差异只影响动态定价空间形状（即影响需求弹性）。在跨期价格均衡区域内,提价和扩容都会加剧消费者战略购买程度,供给越大定价往往越低。战略购买不仅会降低厂商供给、定价和利润水平,改变不同类型消费者之间高低价购买机会,甚至还可能影响定价机制选择和配给策略。压缩过度供给和虚高价格空间可降低战略购买导致的利润损失。本文研究结果可为考虑消费者行为的需求价格理论研究和运营管理实践提供参考。     

基于SRFML-Lift的流程制造产品质量状态监测

对流程制造型企业而言,产品质量状态的监测精度直接影响了企业的生产与运营成本。面对流程工业的多变量监测要求和数据不均衡性,以往研究主要采取局部建模策略或多输出模型,存在特征选择偏差和分类精度不高的问题。对此,本文设计了一种结合SRFML特征选择和Lift学习策略的质量状态监测模型,通过共享不同目标之间的信息以期提升模型的监测效果。首先,根据ReliefF过滤机制,引入重采样赋权思想对工业特征的选择过程进行优化(SRFML);然后,将选择结果作为Lift学习框架的输入,通过类属属性学习方式重塑各待监测特性的特有关联属性;最后采用多个SVM分类器进行训练,得到各目标的质量状态结果。结果表明,本文构建的SRFML-Lift充分学习了原始特征的关键信息,与其他组合策略相比,对质量状态的监测效果更佳,可应用于流程工业的生产管理实践。