Web based resource for Statistical Consultants in the Pharmaceutical Industry

The intention of this article is to highlight sources of web-based reference material and software that will aid consulting statisticians when designing clinical trials. The article includes websites that provide links to explanation of statistical concepts for non-statisticians, regulatory guidelines, and free statistical study design software.     

“大学章程”的中外比较研究——基于中国6所“大学章程”拟定为观照点的实证分析

大学章程为学校内部最高规则,大学章程建设以实现学术自由为其目的,在制度上体现为大学章程对学术自治以及教师权利的保障,而程序规则则是章程遵循形式正义的要求。中国大学章程建设从清末开始至今共经历4个发展阶段。在国家教育部门的积极推动下,2013年11月,国内6所公立高校出台了自己的大学章程,也是《办法》（教育部第31号令）制定以来教育部核准的第一批大学章程,这些章程从一开始即被寄予了依法治校、推进高校改革的美好希冀。在梳理中国大学章程建设的历史沿革、分析国外大学章程特性的基础上,本文拟就6部章程,一窥中国大学章程建设存在的问题,并提出对未来中国大学章程建设的展望。      

Can a treatment be licenced on the basis of post‐treatment predictive biomarkers?

In recent years, there has been a great deal of literature published concerning the identification of predictive biomarkers and indeed, an increasing number of therapies have been licenced on this basis. However, this progress has been made almost exclusively on the basis of biomarkers measured prior to exposure to treatment. There are quite different challenges when the responding population can only be identified on the basis of outcomes observed following exposure to treatment, especially if it represents only a small proportion of patients. The purpose of this paper is to explore whether or when a treatment could be licenced on the basis of post‐treatment predictive biomarkers (PTPB), the focus is on oncology but the concepts should apply to all therapeutic areas. We review the potential pitfalls in hypothesising the presence of a PTPB. We also present challenges in trial design required to confirm and licence on the basis of a PTPB: what's the control population?, could there be a detriment to non‐responders by exposure to the new treatment?, can responders be identified rapidly?, could prior exposure to the new treatment adversely affect performance of the control in responders? Nevertheless, if the patients to be treated could be rapidly identified after prior exposure to treatment, and without harm to non‐responders, in appropriately designed and analysed trials, may be more targeted therapies could be made available to patients. Copyright © 2014 John Wiley & Sons, Ltd.     

民国时期民权观念的变迁:1919年和1934年《县自治法》之比较

北京政府和南京政府分别于1919年和1934年制定《县自治法》,这两部法律在法律用语、自治事项的范围和议会选举权上的差异体现了民国时期民权观念的变迁。自治法规的差异和民权观念的变迁,既与北京政府和南京政府的自身性质有关,又与民权观念的传播和影响程度有关,还与这两个时期的民权实践有关。两部《县自治法》的对比,也说明立法是一项涉及诸多层面的系统工程,传统制度与传统文化、立法者自身的立场、观念和价值追求以及社会发展的现实状况,都会对法律内容的民主性、科学性和进步性产生重大的影响。     

我国新型农村金融机构联动监管模式设计——一个博弈视角下的分析框架

2004年开始的新一轮农村金融增量式改革续写了农村金融发展的新篇章,农村金融机构数量急剧增加,竞争性增强,但由于现阶段我国新型农村金融机构监管模式落后,不能适应我国当前农村金融的快速增长,农村金融改革的主要矛盾已经由农村金融供给跟不上需求的步伐转变成农村金融监管跟不上农村金融组织发展的脚步。因此,创新我国新型农村金融机构监管模式成为破解新一轮农村金融改革突破口。     

论后金融危机时代我国保险消费者的保护

消费者权益得到有效保护是建立现代商业保险制度的标志之一,建立完备的法律制度体系是保护保险消费者权益的基础。从法律的视角观察,健全消费者保护法律制度和监管体系已成为后金融危机时代欧美金融消费者保护的重要取向,也是我国保险消费者保护的着力点。金融危机之后,我国需要进一步完善消费者保护法律制度,确立倾斜性保护法制理念,改善维权法制环境,保障依法自主维权;需要改革现行的监管体系,设立金融消费者保护机构,实现监管功能转型,强化对消费者的依法保护。     

求职过程的宏观-微观分析：多层次模型

本文针对中国大城市不断市场化过程中社会资本对求职过程的影响进行了研究。笔者从新制度主义的宏观与微观的联接理论出发,使用内生互动模型作为实证分析工具,揭示了市场制度的发育具有强化市场行动主体的偏好,即市场化程度、市场不确定性和市场规范性等三个市场化制度的重要特征的发育,均具有增加个体收入的效应,证明宏观制度的演进与诱导微观个体的制度偏好具有亲和性。本文同时证明了边燕杰提出的网络作用空间的“倒U模式”假设。     

论网络出版中的著作权侵权问题及其规制

网络技术的快速发展使出版行业日益走向无纸化时代。网络出版具有突出的比较优势和鲜明的法律特征,也更易于产生一系列严重的著作权侵权问题,亟需通过制定统一法律规范、完善许可使用制度、建立监管体系、加强技术保护和健全集体组织管理等路径加以规制。     

我国食品安全危机的体制成因

近年来,我国频繁爆发的食品安全危机事件使得食品安全问题已成为社会各界关注的焦点.文章在已有研究基础上,从我国现行分段式监管体制入手,阐述了由分段监管导致的监管职能、法律体系、安全标准和检测、认证体系中存在的漏洞及缺陷.并从明确政府部门职责、统一法律体系、完善食品安全标准和加强行业协会作用等方面提出现行食品安全监管体制改革的短期与长期思路.     

Introduction: Accountability in Neuroethics

Pharmaceutical sponsored clinical trials, formerly conducted predominantly in the United States and Europe, have expanded to emerging regions, including the Middle East. Our study explores factors influencing clinical trial privacy and confidentiality in the United Arab Emirates. Factors including concept familiarity, informed consent compliance, data access, and preservation, were analyzed to assess current practices in the Arab world. As the UAE is an emerging region for clinical trials, there is a growing need for regulations related to data confidentiality and subject privacy. Informational and decisional privacy should be viewed within the realms of Arab culture and religious background.