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.     

A non-profit approach to addressing the effects of urbanization in the Lake Pontchartrain Basin, Louisiana

The Lake Pontchartrain Basin in southeast Louisiana is an estuarine watershed encompassing New Orleans, Baton Rouge, and wetlands that are an integral part of Louisiana's unique culture. In recent decades rapid growth and poorly planned development have resulted in a decrease in water quality and habitat loss, especially in St. Tammany Parish on the north shore of Lake Pontchartrain. In 1989, the Lake Pontchartrain Basin Foundation (LPBF), an environmental, non-profit organization, was formed to address and rectify environmental issues in the Basin. LPBF accomplishes its mission through programs addressing water quality, habitat protection, geographic information science, public access, and education.LPBF used the recent, rapid development occurring in St. Tammany Parish as a case study to examine the relationship between land use, water quality, and development in the Basin by investigating habitat change/urbanization, development in flood plains, and water quality. Through the integration of LPBF programs, it was found that urbanization is having a devastating impact on the parish's natural habitats and severely degrading water quality. Using these results, LPBF is educating Basin citizens on the protection of their habitats and water quality to insure that these resources may be available for future generations.     

幼儿父母的教养行为与对子女控制感的关系

研究表明:幼儿家长在教养活动中同时运用支持、惩戒和溺爱三种教养行为,但三种行为在其全部教养行为中所占比例不同,支持行为最多,惩戒和溺爱行为较少;家长的支持教养行为与其对子女的控制感呈正相关,而惩戒和溺爱行为则与控制感呈负相关.     

Religious affiliation and the family

The process of religious affiliation is mediated by institutions such as the family, which provide a network of ties to the public sphere. Variations in the likelihood of those with no religious affiliation in high school (N=900) becoming church members by the time they reach 30 are explained in terms of a combination of individual attributes, such as educational and spatial mobility, and changes in structural location, such as the transition to marital and parental status. Panel data from the Career Development Study show that women's chances of affiliation are more affected than are men's by parents' religious homogamy, getting married, and having children.     

Parent‐Adolescent Involvement: The Relative Influence of Parent Gender and Residence

The 1995 wave of the Add Health study is used to investigate the relative influence of parent gender and residence on patterns of parental involvement with adolescents. Adolescent reports (N =17,330) of shared activities, shared communication, and relationship quality with both biological parents are utilized. A multidimensional scaling analysis reveals that parent gender explains most of the variance in parent‐adolescent involvement, with residential status playing a secondary yet a fundamental role in accounting for these patterns. Resident mothers who do not live with adolescents’ biological fathers engage in the broadest range of activities with their children. Unpartnered resident fathers display patterns of parenting that are as similar to mothers as they are to other fathers.     

论电话监听的合理性及其限度

电话监听是技术侦查手段的一种。适当运用电话监听,能够提高对抗犯罪的效能。然而,电话监听具有对公民隐私权、言论自由权等权利造成侵害的很大的危险性。因此,既要认识到其合理性,又要对其适用确定必要的限度,并在运用过程中,保障犯罪嫌疑人、被告人的基本人权和诉讼权利。     

经济责任审计与执政能力建设的若干思考

从经济责任审计的实际出发，联系工作实践，对目前经济责任审计中存在的问题进行了探讨，并提出了相应的对策，试图能解决当前经济责任审计中碰到的一些问题，进一步加强经济责任审计对权力制约和监督的作用，促进领导干部提高执政能力，推动经济社会全面和谐发展．     

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。     

DS18B20在油气井场温度监控系统中的应用

油气井场温度监控系统属于井场重要的安全保护装置,此系统用单片机+串行智能传感器来组成,广泛使用了串行芯片。介绍了系统硬件流程图,以及温度传感器芯片DS18B20的工作流程,详细说明了获取温度传感器序列号的ROM操作命令、存储器操作命令。