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.     

Loss functions for estimation of extrema with an application to disease mapping

It is often of interest to find the maximum or near maxima among a set of vector‐valued parameters in a statistical model; in the case of disease mapping, for example, these correspond to relative‐risk “hotspots” where public‐health intervention may be needed. The general problem is one of estimating nonlinear functions of the ensemble of relative risks, but biased estimates result if posterior means are simply substituted into these nonlinear functions. The authors obtain better estimates of extrema from a new, weighted ranks squared error loss function. The derivation of these Bayes estimators assumes a hidden‐Markov random‐field model for relative risks, and their behaviour is illustrated with real and simulated data.     

论绿色消费方式的形成

绿色消费是可持续发展的消费方式,它的形成对人类可持续发展具有重要意义。论文主张从建立可持续发展的消费价值观,建立合理的财富分配秩序,调整经济结构和生产方式,并依靠科技进步和发挥政府的主导作用来促进绿色消费的形成。     

科学配置合并组建高校的文献信息资源

组建高校面临着全校文献信息资源的重组和合理配置 ,针对合并组建高校的文献信息资源重组和配置采取正确的对策和措施 ,发挥数字化文献信息资源的作用 ,从而充分发挥合并组建高校文献信息资源的整体效益     

On Rates of Convergence for Bayesian Density Estimation

Abstract.  We consider the problem of estimating a compactly supported density taking a Bayesian nonparametric approach. We define a Dirichlet mixture prior that, while selecting piecewise constant densities, has full support on the Hellinger metric space of all commonly dominated probability measures on a known bounded interval. We derive pointwise rates of convergence for the posterior expected density by studying the speed at which the posterior mass accumulates on shrinking Hellinger neighbourhoods of the sampling density. If the data are sampled from a strictly positive, α -Hölderian density, with α  ∈ ( 0,1] , then the optimal convergence rate n^{− α / (2 α +1)} is obtained up to a logarithmic factor. Smoothing histograms by polygons, a continuous piecewise linear estimator is obtained that for twice continuously differentiable, strictly positive densities satisfying boundary conditions attains a rate comparable up to a logarithmic factor to the convergence rate n ^−4/5 for integrated mean squared error of kernel type density estimators.     

A bayesian estimator for the dependence function of a bivariate extreme‐value distribution

Any continuous bivariate distribution can be expressed in terms of its margins and a unique copula. In the case of extreme‐value distributions, the copula is characterized by a dependence function while each margin depends on three parameters. The authors propose a Bayesian approach for the simultaneous estimation of the dependence function and the parameters defining the margins. They describe a nonparametric model for the dependence function and a reversible jump Markov chain Monte Carlo algorithm for the computation of the Bayesian estimator. They show through simulations that their estimator has a smaller mean integrated squared error than classical nonparametric estimators, especially in small samples. They illustrate their approach on a hydrological data set.     

煤炭城市发展非煤产业研究

煤炭城市产业结构生成和变化的特殊性 ,决定其发展非煤产业具有历史必然性和现实紧迫性。煤炭城市发展非煤产业应选择以煤炭等矿产品的深加工转化型为主 ,以节能综合利用型为辅 ,相关产业配套 ,非相关产业适当发展的模式。模式的实施和实现 ,要依靠国家调整宏观调控政策 ,健康发展煤炭主业 ;要建立煤矿转产基金 ,为非煤产业提供必要的积累 ;要调整投资结构 ,搞好招商引资 ;要制定科技进步政策 ,增强科技创新能力 ;要加强生态环境保护与建设 ,提高可持续发展能力 ;要深化煤炭企业改革 ,加快体制和机制创新 ;要实施人才战略 ,用新机制上新项目     

水资源跨流域配置的经济学分析

由于我国水资源空间分布不均匀的突出特点 ,大型跨流域调水工程已经成为我国国民经济可持续发展的重要支撑。文章从水资源的经济特点出发 ,结合南水北调中线工程 ,对水资源跨流域配置的市场供求、成本收益等资源经济学问题进行了分析 ,并对社会主义市场经济条件下水资源跨流域配置的利益分配机制进行了探讨     

A note on LeCam’s bound for the distance between the Poisson binomial and the Poisson distribution

n possibly different success probabilities p ₁, p ₂, ..., p _n is frequently approximated by a Poisson distribution with parameter λ = p ₁ + p ₂ + ... + p _n . LeCam's bound p ² ₁ + p ² ₂ + ... + p _n ² for the total variation distance between both distributions is particularly useful provided the success probabilities are small. The paper presents an improved version of LeCam's bound if a generalized d-dimensional Poisson binomial distribution is to be approximated by a compound Poisson distribution. Received: May 10, 2000; revised version: January 15, 2001     

随机变量投影的一种应用

利用随机变量的投影关系,定义了偏方差矩阵,从而导出了逆方差阵元素的一种形式在随机变量是正态的条件,它为判别条件独立性有方便的操作办法。