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.     

城市社区基层社会管理组织的变革及其主要原因——建造新的城市社会管理和控制的模式

本文主要是根据有关文献资料和最近对北京市社区建设进行的调查 ,首先对城市街道办事处和居民委员会的历史和变迁进行考察和描述 ,在此基础上探讨城市基层社会管理组织变迁的特点 ,最后分析当前社区建设的主要社会原因 ,提出城市社区建设可以被认为是改革开放后 ,我国城市基层社会管理组织变革的第二个阶段 ,其意义无论是从深度还是广度上都要远远超过单纯的社区服务 ,其首要任务是为了建立和发展能够填补“单位制”解体后的真空 ,以及与城市社会其他重要转型特征相适应的新型城市基层社会的管理和控制机制     

Improved attribute acceptance sampling plans based on maxima nomination sampling

This paper demonstrates the use of maxima nomination sampling (MNS) technique in design and evaluation of single AQL, LTPD, and EQL acceptance sampling plans for attributes. We exploit the effect of sample size and acceptance number on the performance of our proposed MNS plans using operating characteristic (OC) curve. Among other results, we show that MNS acceptance sampling plans with smaller sample size and bigger acceptance number perform better than commonly used acceptance sampling plans for attributes based on simple random sampling (SRS) technique. Indeed, MNS acceptance sampling plans result in OC curves which, compared to their SRS counterparts, are much closer to the ideal OC curve. A computer program is designed which can be used to specify the optimum MNS acceptance sampling plan and to show, visually, how the shape of the OC curve changes when parameters of the acceptance sampling plan vary. Theoretical results and numerical evaluations are given.     

我国乡镇选举改革及其体制约束

乡镇选举改革是我国基层民主发展的突破和政权民主的发端,在我国政治发展进程当中具有战略性意义。由于面临来自政治、法律和制度等层面的冲突,乡镇长直选的改革试点最终停滞不前。随之出现的乡镇党委公推直选,经过广泛试点后仍然面临着与现行人大制度和干部选拔制度的紧张关系。因此,乡镇党委公推直选持续停留在非制度化、非持续化和难以升级的困境之中。     

中医药临床科研应遵循的伦理学原则

当前的中医药临床科研工作,应当在全面遵循伦理学原则的基础上,建立完善并充分发挥医院伦理委员会的指导监督功能,进一步加强对中医药科研人员的伦理道德教育和伦理学知识培训,努力培养造就一支高素质科研人才队伍。这对于保证国家药品监督管理局《药品临床试验管理规范（ＧＣＰ）》的正确实施,充分保障受试者的合法权益,具有十分重要的现实意义。     

基层党组织有限介入：农村社区“两委”候选人的当选逻辑——基于政策文本分析

作为农村社区“两委”换届选举的关键步骤,农村社区“两委”候选人的产生备受关注。借助街道党组织社区“两委”候选人换届政策文本,勾勒出社区“两委”候选人在基层党组织设定的双重候选条件下的当选逻辑,并以fs-QCA定性比较分析法对社区“两委”候选人胜出资质进行检验。结果显示,良好群众基础是潜在候选胜出的必要条件,同时具备群众基础和政绩两要素是潜在候选人胜出的有效途径;仅凭借经济实力或宗族势力等资源禀赋并不能使其成为“两委”正式候选人;街道组织部门受政治稳定逻辑驱使,往往采取多样化策略减少社区选举“变数”。因此,基层党组织对农村社区“两委”选举过程的有限介入并非有损基层民主质量,相反,它使农村社区选举表现出有别于乡村选举的优良特质。     

Toward increased public representation on bioethics committees: Lessons from Judging the cold war human radiation experiments∗

The process of judging the Cold War Human Radiation Experiments illuminates a need to develop a model for an appropriate public role on bioethics committees. A citizen representative was appointed to the President's Advisory Committee on Human Radiation Experiments, and the Committee solicited broad public participation in their investigation. However, many members of the affected and interested public desired further representation on the Committee, as they tended towards stronger ethical condemnations of the experiments than the Committee expressed. I offer an account of a testimony before the Committee by a radiation experiment subject's survivor to illustrate this contrast in moral perspective. I consider some the contributions that “non‐expert”; public members can add to committee deliberations, and suggest that concerns about public representatives may be overcome with the guidance of clearer principles for selecting public members. Further efforts to increase membership by the general and affected public on bioethics committees will enhance deliberations and help realize the democratic ideals of bioethics.     

Urbanization,Proximity, and the Intra-State Context of Women's Representation

ABSTRACT

The impact of context on women candidates has been vigorously studied using comparisons of state-level data and found to be substantial. Many of the variables used in this research were measured at the state level even though their influence is theorized at the district level and observed to vary within states. This essay tests these intra-state contextual influences using regression analysis of state House of Representatives district-level contextual data in four states from 1982-1990. The findings confirm contradict, and provide mixed results for particular state-level results.     

城市社区居委会的功能偏差分析

在中国建立社会主义市场经济体制的同时,城市基层社会管理体制也由单位制向社区居民自治转变。社区自治要求改变原有的高度行政化的城市基层管理机制,突出社区居民委员会在社区管理中的作用,使其成为能胜任自我管理、自我教育、自我服务、自我监督的社区自治组织。通过对哈尔滨市社区居委会的现状调查,社区居委会作为社区自治的核心载体存在着非自治特征及功能偏差现象,阻碍了社区居民自治的实现,并分析了功能偏差产生的原因,探究了社区居委会自治功能回归的思路。     

村委会在农村经济市场化中的角色

农村经济市场化作为统筹城乡发展的手段之一,被认为是有效突破制约农村经济发展瓶颈、解决＂三农＂问题的最根本途径。以两次调查①所得资料为基础,分别以农家乐市场和苹果产业市场的发展为例来分析村委会在农村经济市场化中的角色。通过分析得出：村委会现有的管理职能阻碍了农村经济市场化的进程。促进农村市场经济发展的当务之急是转变村委会职能,建立农村集体经济组织。