Pharmacovigilance in Clinical Trials: Current Practice and Challenges

In view of the MENA increasing participation in multinational trials and the increasing number of national/regional trials, this article explores potential areas of pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. Regulatory silence on expedited reporting requirements creates confusion for local sites that are part of multinational trials. Not allowing waiver for serious adverse events that are protocol specified or are study endpoints, along with lack of emphasis on causality as reporting criteria, adds substantial burden of uninformative cases for regulatory review. Despite global focus on Development Safety Update Report, local regulators are not yet insistent on real-time update of a drug’s cumulative safety profile. Issues like reporting requirements for generic trials, pregnancy reporting and lenient timeline for death/life-threatening events need attention. Finally, the need to formulate an all-encompassing local pharmacovigilance guideline, in sync with global practice cannot be overemphasized.     

How to Evaluate Government Performance while Building a Rule of Law Government in China*

Building a law-based government is a central element of the comprehensive framework for promoting the rule of law in China, while using evaluation to catalyze growth is in line with the incentive principle of management studies. Since China started to implement reform and opening up over thirty years ago, rule of law development and organizational evaluation have gone through several stages, each with different characteristics. Efforts to build a law-based government have met with success, but what the country now has is essentially still goal-oriented assessment. At present, this suffers from the lack of a clear goal orientation or definition of functions, an imperfect technical system and unsound motivation mechanisms, not to mention the practical problems of each government department going its own way, duplicating evaluations or being left rudderless. Drawing on a combination of value rationality and instrumental rationality and using government performance evaluation to promote the building of a law-based government not only conforms to the spirit of the rule of law and value rationality in government performance, but also strengthens the role of evaluation as an instrument for organizational management. Therefore, we need to create new evaluation theories, expand public participation, introducing diversified evaluating entities, improve technical systems, strengthen institutional buildup, and foster a performance-based culture. In addition, replacing goal-oriented assessment with performance evaluation will help the emergence of a new discipline—the performance evaluation of rule of law government, thus promoting multidisciplinary efforts to integrate and create new public administration theories in China.     

房屋拆迁中的国有土地使用权补偿司法实证研究

房屋拆迁中的国有土地使用权补偿是我国城镇房屋拆迁中的主要矛盾点之一。通过对司法判例进行实证研究发现，法院判决多数认为原告诉请国有土地使用权补偿于法无据，抑或认为对于国有土地使用权的补偿已随房屋评估作价。房屋拆迁的重点在于“地”，若仅对房屋所有权人进行补偿，而忽视国有土地使用权人，无疑会引发诸多诉讼，乃至于阻碍城镇化进程。因此，在渐进式改革的背景之下，可以开展国有土地使用权补偿的试点，同时应当完善《国有土地上房屋征收与补偿条例》，并将合理补偿原则作为补偿的基本原则，以此为基础建立一套独立于房屋拆迁补偿的国有土地使用权补偿体系。     

How Moroccan‐Dutch parents learn in communities of practice: Evaluating a bottom‐up parenting programme

Research shows that top‐down‐designed parenting programmes do not always meet the needs of postmigration parents. Bottom‐up programmes by migrant organizations hold a promise to fill this gap; however, research about these programmes and appropriate evaluation methodologies is scarce. Drawing upon Wenger's ( 2010 ) “communities of practice,” this paper explores an alternative perspective on parenting programme evaluation. Findings are presented from a study looking into social learning processes of postmigration parents who participated in a bottom‐up programme about raising teenagers in urban areas. Using an ethnographically inspired method combined with a preprogramme and postprogramme design, 115 Moroccan‐Dutch mothers and fathers from 15 programme groups participated. Results show that the programme provided a social learning space in which parents used themselves as resources to learn collectively about parenting. Moreover, parents consciously engaged in learning interactions across learning spaces stretched into their social networks. These analyses showed how parents' development of “learning citizenship” (Wenger, 2009 ) provides us with insight in collective learning dimensions present in a bottom‐up parenting programme, which is often not included in evaluation studies. Implications for practitioners as facilitators of parents' collective learning are presented.     

Practice Wisdom Meets Evidence-Based Practice: Building Capacity in Agencies

Agencies have a need to develop and evaluate therapeutic practices that show efficacy in treating specific client problems. University-agency collaborations combine the wisdom of practitioners with research skills that appraise evidence of efficacy, operationalize concepts and skills, and identify and implement evaluation methods. This article discusses the processes involved as practitioners and administrators collaborated with university researchers to transform a well-established mutual aid (MA) model of group work into an evidence-based model that showed efficacy in preventing substance use with adolescent populations. A case study will include the phases of the collaboration including relationship building, reviews of similar programs, identification of appropriate evaluation measures, development of a curricular-based manual and analysis and interpretation of the data for use in applying for funding. Implications for agency practice that respond to current demands in social services will be discussed.     

Costs of promoting cancer screening: Evidence from CDC’s Colorectal Cancer Control Program (CRCCP)

The Colorectal Cancer Control Program (CRCCP) provided funding to 29 grantees to increase colorectal cancer screening. We describe the screening promotion costs of CRCCP grantees to evaluate the extent to which the program model resulted in the use of funding to support interventions recommended by the Guide to Community Preventive Services (Community Guide). We analyzed expenditures for screening promotion for the first three years of the CRCCP to assess cost per promotion strategy, and estimated the cost per person screened at the state level based on various projected increases in screening rates. All grantees engaged in small media activities and more than 90% used either client reminders, provider assessment and feedback, or patient navigation. Based on all expenditures, projected cost per eligible person screened for a 1%, 5%, and 10% increase in state-level screening proportions are $172, $34, and $17, respectively. CRCCP grantees expended the majority of their funding on Community Guide recommended screening promotion strategies but about a third was spent on other interventions. Based on this finding, future CRC programs should be provided with targeted education and information on evidence-based strategies, rather than broad based recommendations, to ensure that program funds are expended mainly on evidence-based interventions.     

城市管理导向的居民幸福指数测评研究——以安徽省为例

提高居民的幸福指数是新常态下城市管理的重点工作。在综述以往研究的基础上，以需要层次论作为理论依据，整合2015年度安徽省统计年鉴数据完整、准确的指标，构建了安徽省城市居民幸福指数体系，经过数据收集、统计、分析和综合，得出16个城市居民综合幸福指数、基本需求幸福指数、发展需求幸福指数、享受需求幸福指数分值，对结果及其应用价值进行了讨论。     

马克思主义教育实效分析——以武汉工业学院为例

通过对高校思想政治理论课教学的评价、学生对该课的参与程度,以及该课教学中存在的问题、改进意见和建议等情况进行调查,结果显示,教学内容、教师素质、教学方式是影响当前高校思想政治理论课教学效果的三个主要方面。     

基于信息反馈的实践教学质量评价体系构建

提出了一种基于信息反馈的实践教学质量评价体系,依据实践教学过程中的各种信息反馈,动态地调整对于实践教学各指标的评价。评价的结果反映了实践教学各个阶段、各个环节的表现,从而提升教师参与实践教学的积极性与有效性,促进实践教学管理水平的提高。     

基于循环经济理论的产业集群生态化发展评价研究

引入循环经济理念,建立科学评价产业集群生态化发展的体系和方法,对引导产业集群合理有序的发展具有十分重要的意义。从经济效益、环境效益和社会绩效三个方面着手,构建符合循环经济特征的产业集群生态化发展评价指标体系,计算出各指标的评价值及其在评价体系中的权重以后,采用线性加权求和法求得产业集群生态化发展的综合评分值,既可对产业集群某一时期生态化发展水平及三个维度间的关系作出客观的评价,找到存在的问题和差距。