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1.
Stephen J. Ruberg Frank E. Harrell Jr. Margaret Gamalo-Siebers Lisa LaVange J. Jack Lee Karen Price 《The American statistician》2019,73(1):319-327
ABSTRACTThe 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. 相似文献
2.
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。 相似文献
3.
Chandan Saha Michael P. Jones 《Journal of the Royal Statistical Society. Series B, Statistical methodology》2005,67(1):167-182
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. 相似文献
4.
邓莉 《重庆交通学院学报(社会科学版)》2002,2(3):46-49
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. 相似文献
5.
从部门本位回归到基本理性——对检察机关职权配置的思考 总被引:1,自引:0,他引:1
高一飞 《山西大学学报(哲学社会科学版)》2008,31(6):86-91
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。 相似文献
6.
杨文杰 《宝鸡文理学院学报(社会科学版)》2006,26(4):100-103,125
对审委会制度的改革,有人主张废除审委会制度为其核心内容;也有人主张目前应在保留的基础上予以改革和完善。废改之争,焦点是研究方法之争。主废和主改各有其弊,应通过立法程序按照“不审不判”的思路重塑审委会制度,明确审委会审判组织的地位,赋予其合议、陪审、咨询、调研四大职能及案件实体决定权和指导权,并建立和完善相应的程序。 相似文献
7.
Alan Phillips Alan Ebbutt Lesley France David Morgan Mick Ireson Lesley Struthers Guenter Heimann 《Pharmaceutical statistics》2003,2(4):241-251
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. 相似文献
8.
一种自适应斜坡补偿电路 总被引:1,自引:0,他引:1
基于CMOS工艺设计了一种能够自动调节补偿斜率的斜坡补偿电路。该电路可以跟随输入和输出信号的变化,相应地给出适当的斜坡补偿量,不仅使得峰值电流模式BOOST变换器可以稳定工作,而且可以避免补偿不当的现象,保证变换器有足够快的瞬态响应。仿真结果表明该电路产生的斜坡补偿信号的精度可以达到83%以上。 相似文献
9.
Peter B. Gilbert 《Journal of the Royal Statistical Society. Series C, Applied statistics》2005,54(1):143-158
Summary. To help to design vaccines for acquired immune deficiency syndrome that protect broadly against many genetic variants of the human immunodeficiency virus, the mutation rates at 118 positions in HIV amino-acid sequences of subtype C versus those of subtype B were compared. The false discovery rate (FDR) multiple-comparisons procedure can be used to determine statistical significance. When the test statistics have discrete distributions, the FDR procedure can be made more powerful by a simple modification. The paper develops a modified FDR procedure for discrete data and applies it to the human immunodeficiency virus data. The new procedure detects 15 positions with significantly different mutation rates compared with 11 that are detected by the original FDR method. Simulations delineate conditions under which the modified FDR procedure confers large gains in power over the original technique. In general FDR adjustment methods can be improved for discrete data by incorporating the modification proposed. 相似文献
10.
林涛 《西北第二民族学院学报》2005,(4):31-36
中亚的东干人不仅为该地区的社会经济发展作出了巨大的贡献,而且创造了海外华人历史上的奇迹.他们将带到中亚地区的汉语西北方言拼音化,使用38个斯拉夫字母拼写东干语,采用了词式书写,制订了正字法规则,出版了书报杂志,编写了东干文教科书,并在此基础上还培养了一大批诗人和作家,发展了东干族文学、教育和民族文化.东干文是汉语拼音文字的成功尝试,它为我国现代汉语音素文字的创制和词式书写的语言规化理论和实践提供了有益的经验和启发. 相似文献