Empirical evaluation of the implementation of the EMA guideline on missing data in confirmatory clinical trials: Specification of mixed models for longitudinal data in study protocols

In confirmatory clinical trials, the prespecification of the primary analysis model is a universally accepted scientific principle to allow strict control of the type I error. Consequently, both the ICH E9 guideline and the European Medicines Agency (EMA) guideline on missing data in confirmatory clinical trials require that the primary analysis model is defined unambiguously. This requirement applies to mixed models for longitudinal data handling missing data implicitly. To evaluate the compliance with the EMA guideline, we evaluated the model specifications in those clinical study protocols from development phases II and III submitted between 2015 and 2018 to the Ethics Committee at Hannover Medical School under the German Medicinal Products Act, which planned to use a mixed model for longitudinal data in the confirmatory testing strategy. Overall, 39 trials from different types of sponsors and a wide range of therapeutic areas were evaluated. While nearly all protocols specify the fixed and random effects of the analysis model (95%), only 77% give the structure of the covariance matrix used for modeling the repeated measurements. Moreover, the testing method (36%), the estimation method (28%), the computation method (3%), and the fallback strategy (18%) are given by less than half the study protocols. Subgroup analyses indicate that these findings are universal and not specific to clinical trial phases or size of company. Altogether, our results show that guideline compliance is to various degrees poor and consequently, strict type I error rate control at the intended level is not guaranteed.     

Population aging and long-term care policies in the Gulf region: a case study of Oman

Population aging is a phenomenon occurring across the globe including in countries traditionally exhibiting population dividends and “youth bulges.” The Gulf Corporation Council countries are no exception as they currently experience a process of population aging, albeit at a different stage from many developed countries. However, due to historically high fertility rates and fast-paced epidemiological transition, some of these countries will experience population aging at a higher pace than what has been observed in Europe and the United States. This article reviews recent developments in long-term care policies in the Gulf region with a focus on Oman as an example of a high-income Arab country that is experiencing population aging while still being governed by traditional family aged-care norms. Utilizing existing data and published research complemented by policy analysis and field visits, we analyze the process of population aging in Oman and neighboring countries and its policy implications.     

Social policies and solidarity during the Greek Crisis

This article provides a succinct overview of the phenomenon of solidarization in crisis‐ridden Greece. Brief accounts of the pre‐ and post‐crisis situation in four core social policy areas (health, employment, housing, education) are combined with the presentation of four illustrative case studies, one for each of the aforementioned areas. Drawing on a broad range of primary and secondary data, including 20 in‐depth interviews with key stakeholders and end‐users of the actions examined, we argue that while the crisis provoked a further “residualization” of the institutionalized solidarity system, it also triggered the development of new solidarity ventures, both by state and non‐state actors, often even including partnerships between them. These ventures reflect the building of a bridge between institutionalized and informal solidarity in Greece and the shift towards a new type of mixed, although fragmented, mode of solidarity.     

我国亲告罪追诉模式之困境及其重构——以网络诽谤案件的证据收集问题为切入点

网络诽谤犯罪属于《刑法》规定的亲告罪类型,此类案件中被害人的证据收集能力受到较大制约,导致其面临“自诉困境”。对此问题,不论是亲告罪的选择性公诉化,还是公权力适当介入证据收集过程的处理路径均存在不足。《刑法修正案(九)》针对网络侮辱、诽谤犯罪的证据收集问题作出新规定,但是无法扩张适用于所有亲告罪类型。亲告罪的自诉困境凸显出我国对亲告罪确立的单纯自诉制追诉模式存在显著缺陷：不利于对被害人的平等保护,以及混淆告诉权和举证责任。重构亲告罪追诉模式的前提是对刑事法中的“告诉”进行重新解释,使其本质回归为诉讼条件,与证明责任“解绑”。在模式选择上,应确立混合告诉制的追诉模式,被害人提起告诉后,可以自主选择适用自诉程序还是公诉程序。     

中国蔬菜价格波动与通货膨胀——基于波动来源的分解

利用Census X12季节调整和H-P滤波法,将蔬菜价格波动来源分解为趋势变动、季节变动、循环变动和不规则变动要素。利用Bootstrap因果检验与VAR模型,考察了蔬菜价格波动来源的分解因素与中国通货膨胀的关联性。结果表明,蔬菜价格波动影响消费者物价指数的主要渠道是通过季节变动和不规则变动要素;季节变动因素对消费者物价指数的影响呈季节周期性;不规则变动对消费者物价指数的冲击在最初时最显著,随后逐渐减弱。政策含义为,降低公众的通胀预期、促进蔬菜跨区域流通、控制蔬菜运输的物流成本、健全政府灾害天气应急响应机制均有利于减缓CPI上涨。     

欧美商业银行金融信息化发展对我国的启示

金融信息化是随着西方金融发展趋势递进的,同时又是在金融业和信息技术相互作用中不断发展的.目前跨国经营和混业经营成为发达国家金融业的主流模式,信息化已成为影响现代金融发展的核心要素,成为欧美金融业发展和创新的重要驱动力.本文介绍了欧美银行业信息化发展的趋势,通过对比我国金融信息化的现状,提出我国要借鉴发达国家银行业信息化的经验,同时结合自身优点及特点,提升我国银行业信息化水平.     

民族共生理论:散杂居民族关系及目标范示研究

本文以生物学中的共生理论为参照,基于生物共生理论的理念范畴和分析方法,结合生物共生理论在其他领域的研究成果,重点考察了我国散杂居民族的共生关系,并提供了民族共生目标范式以及实现途径.     

金融控股公司的金融创新

随着中国加入WTO，外资银行涌人中国，新的经营模式和经营理念也随之而来，中国银行面临前所未有的考验。文章通过分析西方国家银行经营模式的变迁轨迹，并结合中国国情，认为金融控股公司是我国开展混业经营的最佳模式，解决好金融创新是我国发展金融控股公司的第一要务。     

后危机时代我国地方金融控股公司发展研究

在全球金融业务综合化背景下,金融控股公司大行其道。我国在政策法规层面虽然没有明确涉及金融控股公司,但这类金融机构事实上早已存在。文章在回顾国内外金融控股公司发展历程的基础上,对中国地方金融控股公司的发展状况与动因进行了剖析,进而对金融控股公司发展的法律瓶颈与政策动态进行梳理,针对性地提出了我国地方金融控股公司建设的政策建议。     

十六届三中全会后我国所有制问题最新研究综述

党的十六届三中全会提出,“要大力发展混合所有制经济,使股份制成为公有制的主要实现形式”,引发经济学界对所有制问题展开了激烈的争论。学界对混合所有制经济提出许多不同的理解,对股份制企业的所有制性质作出许多不同的判断。鉴于此,本文对十六届三中全会以来国内对所有制问题的争论作一个简要的综述,以反映我国所有制问题研究的最新进展。