Adaptive and repeated cumulative meta‐analyses of safety data during a new drug development process

During a new drug development process, it is desirable to timely detect potential safety signals. For this purpose, repeated meta‐analyses may be performed sequentially on accumulating safety data. Moreover, if the amount of safety data from the originally planned program is not enough to ensure adequate power to test a specific hypothesis (e.g., the noninferiority hypothesis of an event of interest), the total sample size may be increased by adding new studies to the program. Without appropriate adjustment, it is well known that the type I error rate will be inflated because of repeated analyses and sample size adjustment. In this paper, we discuss potential issues associated with adaptive and repeated cumulative meta‐analyses of safety data conducted during a drug development process. We consider both frequentist and Bayesian approaches. A new drug development example is used to demonstrate the application of the methods. Copyright © 2015 John Wiley & Sons, Ltd.     

关于高校学报非核心期刊生存与发展的思考

高校学报属于学术期刊,是高等学校主办的以反映高校科研和教学成果为主的学术理论刊物。在学术期刊实行核心期刊与非核心期刊的评价机制后,高校学报中的非核心期刊面临着严峻的生存与发展危机。面对困境,学报中的非核心期刊应该在不断提高编辑人员自身素养的前提下,认清发展方向,准确定位,办出特色,不断增强自身竞争力。     

当代中国公共经济体制的功能目标及其构建原则

公共经济体制作为处理公共经济中各方面当事人之间责任分工、权力配置和利益分配的规则体系,其科学性高低,不仅对于公共经济生产力能否有效发挥、公共经济资源能否合理配置和整个公共经济体能否健康持续发展至关重要,而且还会对整个混合经济体的动力、活力和国际竞争力产生关键性作用。从公共经济学角度考察,国家治理体系和治理能力现代化的实质乃是公共经济管理的现代化,而公共经济体制的科学化是公共经济管理现代化的核心和基础,因而推进国家治理体系和治理能力现代化需要完善的公共经济体制为根基。构建一整套系统完备的公共经济体制,更需要按照科学的功能目标和正确的指导原则加以统筹设计,才能取得良好的治理效果。     

从话语权看中国特色大国外交话语的建构原则

中国特色大国外交话语体系的建构需要考虑多元文化之间的话语权竞争,结合话语传播中要素资源的利用来确定基本原则。这要求我们克服西方二元对立的话语权力观,树立社会建构主义的辩证话语权力观。我们需要挖掘中国优秀传统文化,融合其他民族的优秀文化,建立科学的中国特色外交话语理论体系,适时提出中国话题和中国方案,增强我国的内容掌控权。在参与者上,除传统外交中的政府机构和人员外,还需要组织调动各种非政府组织、企业、机构、个人参与公共外交话语活动,利用通俗方式对外方的普通民众进行潜移默化的宣传解释。在平台上,在加强对传统媒介资源的利用之外,还要充分调动书刊、影视、广告、自媒体等大众传媒手段,增强我国的媒体控制权。这些原则须置于整体外交话语体系之中,保证我国外交话语体系的建构有助于增强我国的外交话语权。     

国家与农村关系的演变与新型危机

国家与农村之间的关系格局并非一成不变,随着社会基础的变迁会发生一系列转型。根据国家对待农村的方式以及在此基础上形成的相互关系可以发现,新中国成立以来国家与农村关系始终处于调适变动之中,具体呈现为“汲取式下沉”“汲取式悬浮”“供给式下沉”以及“供给式悬浮”四种样态。在实施乡村振兴战略过程中,国家权力在乡村社会正面临一种新型危机:“供给式悬浮”。“供给式悬浮”在基层最突出的表现便是国家惠农政策落实不力与基层政权存在脱离群众的惯性,新一轮因“供给式悬浮”带来的治理性危机很可能冲击国家基层政权的合法性,这需要引起积极反思与高度警惕。     

基于HFACS的海上浮动核电站人因失误影响因素研究

为了保证海上浮动核电站的安全运行,系统了解海上浮动核电站中存在的人因影响因素,以小型反应堆及船舶人因失误因素分析为基础,总结海上浮动核电站人因失误特点,建立了HFACS模型,从外部因素、组织因素、不安全监管、不安全行为前提条件以及不安全行为等5个方面探讨了海上浮动核电站人因失误影响因素,并从人、物、制度与程序、组织与管理等角度提出人因失误防控措施,为海上浮动核电站人因风险分析提供理论参考。     

江苏省徐州市中医文化软实力研究

中医是我国优秀的文化资源,也是文化软实力的重要组成部分,提升江苏省中医文化软实力是健康江苏建设的重要任务。文章以增强徐州市中医文化软实力,传承中医文化为目的。从知识生产力、价值吸引力和社会影响力三个维度具体分析江苏省徐州市中医文化内涵,根据《中国卫生统计年鉴》的相关数据,总结徐州市中医文化软实力的优势和不足。     

Examining concepts of power and agency in research with young people

Concepts of power and agency have become increasingly prominent in the youth studies literatures and related research. A focus of the research to date has been an examination of how a better understanding of young people's lived experiences can reveal possibilities for young people's agency to emerge. Despite increased interest in the term agency, much less has been said about how the concept is defined and recognized in research with young people, including what the concept may entail but crucially, how the term is linked to and underpinned by the related concept of power. This paper seeks to contribute to our understanding of power and agency as utilized in research with young people. The discussion that follows identifies the possible ways in which different theoretical positions shape our understanding of how power and agency are investigated and how these understandings inform the ways we interpret young people's perspectives and actions as holding potential for ‘agency’. Drawing on recent empirical examples, we consider how varying interpretations of power and/or agency shape not only the ways in which young people's agentic experiences are theorized (and the related ontological and epistemological assumptions these positions imply) but also the presumed effects of that agency.     

A randomized Baumgartner statistic for multivariate two-sample testing hypothesis

In this paper, multivariate two-sample testing problems were examined based on the Jure?ková–Kalina's ranks of distances. The multivariate two-sample rank test based on the modified Baumgartner statistic for the two-sided alternative was proposed. The proposed statistic was a randomized statistic. Simulations were used to investigate the power of the suggested statistic for various population distributions.     

To adjust or not to adjust for baseline when analyzing repeated binary responses? The case of complete data when treatment comparison at study end is of interest

The benefits of adjusting for baseline covariates are not as straightforward with repeated binary responses as with continuous response variables. Therefore, in this study, we compared different methods for analyzing repeated binary data through simulations when the outcome at the study endpoint is of interest. Methods compared included chi‐square, Fisher's exact test, covariate adjusted/unadjusted logistic regression (Adj.logit/Unadj.logit), covariate adjusted/unadjusted generalized estimating equations (Adj.GEE/Unadj.GEE), covariate adjusted/unadjusted generalized linear mixed model (Adj.GLMM/Unadj.GLMM). All these methods preserved the type I error close to the nominal level. Covariate adjusted methods improved power compared with the unadjusted methods because of the increased treatment effect estimates, especially when the correlation between the baseline and outcome was strong, even though there was an apparent increase in standard errors. Results of the Chi‐squared test were identical to those for the unadjusted logistic regression. Fisher's exact test was the most conservative test regarding the type I error rate and also with the lowest power. Without missing data, there was no gain in using a repeated measures approach over a simple logistic regression at the final time point. Analysis of results from five phase III diabetes trials of the same compound was consistent with the simulation findings. Therefore, covariate adjusted analysis is recommended for repeated binary data when the study endpoint is of interest. Copyright © 2015 John Wiley & Sons, Ltd.