Modifications of sequential designs in bioequivalence trials

Bioequivalence (BE) studies are designed to show that two formulations of one drug are equivalent and they play an important role in drug development. When in a design stage, it is possible that there is a high degree of uncertainty on variability of the formulations and the actual performance of the test versus reference formulation. Therefore, an interim look may be desirable to stop the study if there is no chance of claiming BE at the end (futility), or claim BE if evidence is sufficient (efficacy), or adjust the sample size. Sequential design approaches specially for BE studies have been proposed previously in publications. We applied modification to the existing methods focusing on simplified multiplicity adjustment and futility stopping. We name our method modified sequential design for BE studies (MSDBE). Simulation results demonstrate comparable performance between MSDBE and the original published methods while MSDBE offers more transparency and better applicability. The R package MSDBE is available at https://sites.google.com/site/modsdbe/ . Copyright © 2015 John Wiley & Sons, Ltd.     

浅谈学生社团活动对德育的促进作用

由学生自己组织、自己设计、自己参加、与娱乐、兴趣相系的社团活动,由于运作模式与隐蔽德育意图和无意识教育艺术精神暗合,具有良好的德育效果。尤其是对学生的爱国主义与爱校情怀、集体主义精神、奉献仁爱之心、社会公益之心、博爱乐群之心、并重自爱与利他之心,具有独到的促进作用。     

加快经济发展 促进苏中崛起

加快苏中发展 ,对于提升苏中经济实力 ,促进全省初步实现现代化 ,意义十分重大。苏中经济发展速度虽一度减缓 ,但仍具有一定的优势。针对苏中自身发展动力不足的现状 ,必须“以外促内 ,以内引外” ,大力引进外资、台资、民资和智力 ,主动接受上海、苏南的辐射和转移 ,同时进行存量结构调整 ,提升整体水平 ,实现跨越式发展。     

文学史的核心价值与古今演变

本文着重分析在过去的文学史研究中古代与现代相互隔绝的成因与弊病 ,提出从重新阐释中国文学的历史与传统入手 ,沟通古今文学 ,研究其演变的过程 ;提出文学史的核心价值是文学与人性发展的关系、文学在此发展过程中的作用 ,并主张以此核心价值为主线来研究古今文学之演变。     

以旅游业为龙头推进西部地区城镇化建设

城镇化是人类社会发展和进步的必然趋势 ,是衡量一定地域经济社会发展水平和文明程度的重要标志。针对我国西部地区以农村人口为主和城镇与农村并存的特点 ,西部要发展就必须找准突破口 ,加强地方经济建设 ,推进城镇化进程     

Sample size re‐estimation incorporating prior information on a nuisance parameter

Prior information is often incorporated informally when planning a clinical trial. Here, we present an approach on how to incorporate prior information, such as data from historical clinical trials, into the nuisance parameter–based sample size re‐estimation in a design with an internal pilot study. We focus on trials with continuous endpoints in which the outcome variance is the nuisance parameter. For planning and analyzing the trial, frequentist methods are considered. Moreover, the external information on the variance is summarized by the Bayesian meta‐analytic‐predictive approach. To incorporate external information into the sample size re‐estimation, we propose to update the meta‐analytic‐predictive prior based on the results of the internal pilot study and to re‐estimate the sample size using an estimator from the posterior. By means of a simulation study, we compare the operating characteristics such as power and sample size distribution of the proposed procedure with the traditional sample size re‐estimation approach that uses the pooled variance estimator. The simulation study shows that, if no prior‐data conflict is present, incorporating external information into the sample size re‐estimation improves the operating characteristics compared to the traditional approach. In the case of a prior‐data conflict, that is, when the variance of the ongoing clinical trial is unequal to the prior location, the performance of the traditional sample size re‐estimation procedure is in general superior, even when the prior information is robustified. When considering to include prior information in sample size re‐estimation, the potential gains should be balanced against the risks.     

And I Still Love Them: On Touching Loss

In this article, the author performs a re‐membering practice that incorporates a relational materialist theory. It traces the disturbances that follow in the wake of three deaths in her family. Written in an autoethnographic voice, the article is a polyphonic composition of the narrative therapy approach of re‐membering entangled with the spacetimematter of silence, speaking, sitting, staying, presence, absence, loss of momentum, dreams, trees, books, cardiac pace‐makers, writing, breath, ashes, murmuring, suffering. Thus, the dispersed agencies of bodies, human and non‐human, reinvigorate a linguistic practice and the author's personal and professional life.     

A not so strange silence: Why qualitative researchers should respond critically to the qualitative data archive

A driving force behind the establishment of a qualitative data archive in the United Kingdom has been the oral historian, Paul Thompson. He has complained that there is a ‘strange silence’ among qualitative sociologists on re‐analysis, and that many have been reluctant to deposit data. The first part of the paper suggests that the common ethical and practical objections can be overcome in establishing an archive in Australia. However, there is a more serious underlying ideological objection: that archiving promotes and institutionalises a narrow empiricist version of qualitative research. The rest of the paper makes this case by examining teaching materials on a British website, by reviewing Thompson's arguments, and by considering some examples of re‐analysis by sociologists. It is argued that qualitative researchers should respond critically, but that it is possible to address and overcome these problems when developing an Australian archive.     

王韶《平戎策》中处理民族关系的原则及借鉴意义--兼补辑《全宋文》中的王韶文

王韶是北宋神宗朝开拓熙河而立下赫赫战功的大军事家、政治家.其<平戎策>提出了恩信招抚、汉法教化、平等相待、杂居互学、发展经济等处理民族关系的原则,在今天仍具有借鉴意义.另为<全宋文>补辑王韶文五篇.     

亲子关系促进工作坊--家庭社会工作的示范

和谐家庭是构建和谐社会的基础。利用团体辅导技术,专业的社会工作在微观层面帮助改善家庭亲子关系,帮助父母提高与孩子沟通技巧,实现社会工作助人自助的宗旨和目的。在校园社会内部,教职工也面临家庭亲子关系这一家庭与社会问题。本文以一个校园亲子关系促进工作坊案例,解释亲子工作坊实务工作的理论依据与相关研究,表明了社会工作专业参与建设和谐社会的价值和潜力。