Inference and Decision Making for 21st-Century Drug Development and Approval

ABSTRACT

The cost and time of pharmaceutical drug development continue to grow at rates that many say are unsustainable. These trends have enormous impact on what treatments get to patients, when they get them and how they are used. The statistical framework for supporting decisions in regulated clinical development of new medicines has followed a traditional path of frequentist methodology. Trials using hypothesis tests of “no treatment effect” are done routinely, and the p-value < 0.05 is often the determinant of what constitutes a “successful” trial. Many drugs fail in clinical development, adding to the cost of new medicines, and some evidence points blame at the deficiencies of the frequentist paradigm. An unknown number effective medicines may have been abandoned because trials were declared “unsuccessful” due to a p-value exceeding 0.05. Recently, the Bayesian paradigm has shown utility in the clinical drug development process for its probability-based inference. We argue for a Bayesian approach that employs data from other trials as a “prior” for Phase 3 trials so that synthesized evidence across trials can be utilized to compute probability statements that are valuable for understanding the magnitude of treatment effect. Such a Bayesian paradigm provides a promising framework for improving statistical inference and regulatory decision making.     

服务台可修的多水平优先权排队(二)

文献[1]讨论了服务台可修的多水平优先权排队的排队指标。本文讨论该系统的可靠性指标。利用文献[3]中的随机序,获得了这些可靠性指标的界值。     

我国民事审级制度的改革与完善——比较法学视角下的分析

比较分析中国、日本、德国、美国、法国及我国台湾地区的民事审级制度可以看出我国审级制度中存在的弊端。实际上 ,实行有条件的三审终审制更具合理性。为此 ,我国原有的两审终审制必须加以改革 ,那就是实行以两审终审为原则、以三审终审为例外的民事审级制度。     

Living Arrangements, Employment Status, and the Economic Well-Being of Mothers: Evidence from Brazil, Chile, and the U.S

Using data from Brazil, Chile, and the U.S., we estimate country specific models of household income that characterize mothers according to their marital status, living arrangement, and employment status. We assess the predicted economic well-being of each type of mother relative to a benchmark of married mothers in the same country, and at various points in the income distribution. We find dramatic cross-country differences in the distribution of mothers across categories, but few differences in each type's relative economic status. In all three countries and at all points in the income distribution, mothers who are the only adults in their households have the lowest levels of predicted income, while married mothers—followed closely by cohabitors—have the highest levels.     

地力山土族生计方式与家庭经济结构

地力山是甘南藏族自治州卓尼县杓哇土族乡的一个纯土族自然村。由于特定的历史、自然和社会原因,形成了以农为主牧业为辅的传统生计方式。随着时代的变化,兼事务工成为了传统生计方式的补充。在地力山土族家庭经济过程中,生计方式支配着资源要素的投入方向,而资源要素在不同方向上的配置最终构成其家庭经济的各个形态,形态之间以及具体形态内部存在的动态性,为其进一步调整提供了内在条件。     

商品经济是农村合作经济组织发展的重要条件

当前农村合作经济组织的兴起和蓬勃发展不是孤立的社会现象,而是农民在商品经济条件下的理性选择.一方面,合作经济组织是商品经济发展的必然要求;另一方面,正是由于商品经济的发展创造和拓展了合作经济组织的生存空间.     

Social Stratification and the Division of Household Labor in Japan: The Effect of Wives' Work on the Division of Labor among Dual-earner Families

Abstract:  This article explores the relationship between social stratification and the division of household labor by examining how the contribution to housework by husbands in dual-earner families varies across the Japanese social stratification structure. First, I review previous studies concerning the determinants of husbands' participation in housework and construct four hypotheses regarding the relative resources explanation, the time constraints explanation, the ideology/sex role explanation, and the alternative manpower explanation. Second, I examine the empirical support for these hypotheses in dual-earner couples and the effect of social stratification on husband's participation in housework, which has not been studied thus far. Third, I investigate the effect of social stratification in more detail. According to the results of TOBIT regressions and other supplementary analyses, the principal findings are as follows:

• 1) 

  the relative resources explanation is not supported;

       

Asymptotic bias in the linear mixed effects model under non-ignorable missing data mechanisms

Summary.  In longitudinal studies, missingness of data is often an unavoidable problem. Estimators from the linear mixed effects model assume that missing data are missing at random. However, estimators are biased when this assumption is not met. In the paper, theoretical results for the asymptotic bias are established under non-ignorable drop-out, drop-in and other missing data patterns. The asymptotic bias is large when the drop-out subjects have only one or no observation, especially for slope-related parameters of the linear mixed effects model. In the drop-in case, intercept-related parameter estimators show substantial asymptotic bias when subjects enter late in the study. Eight other missing data patterns are considered and these produce asymptotic biases of a variety of magnitudes.     

追求自我解放 寻觅自由人生--劳伦斯笔下的理想女性厄秀拉

劳伦斯笔下的叛逆女性厄秀拉是劳伦斯塑造的最理想的人物.她为人正直,追求真理与不合理的社会进行奋力抗争,虽屡遭失败,仍不放弃追求,最后在大自然和周游世界中获得了自由.厄秀拉的这种追求是作家拯救西方人摆脱精神危机的有价值的尝试.     

从部门本位回归到基本理性——对检察机关职权配置的思考

目前,我国法学界对检察机关职权配置问题存在着激烈的争论。争论的主要问题有三个。其中,检察机关是否有侦查权是个伪问题,其本质是检察机关行使侦查权时由谁来监督;检察官不是“中立及超然”的司法人员,不应当有对强制措施的批准权;检察官不应当以居高临下的“法律监督者”的身份监督审判程序,而是应当通过程序动议权和上诉权监督审判程序。目前主张维持检察机关职权现状的学者,有严重的部门本位主义,检察权改革应当摒弃部门本位主义。