Statistical considerations in clinical trial design with event-free survival as the primary efficacy endpoint

In late-phase confirmatory clinical trials in the oncology field, time-to-event (TTE) endpoints are commonly used as primary endpoints for establishing the efficacy of investigational therapies. Among these TTE endpoints, overall survival (OS) is always considered as the gold standard. However, OS data can take years to mature, and its use for measurement of efficacy can be confounded by the use of post-treatment rescue therapies or supportive care. Therefore, to accelerate the development process and better characterize the treatment effect of new investigational therapies, other TTE endpoints such as progression-free survival and event-free survival (EFS) are applied as primary efficacy endpoints in some confirmatory trials, either as a surrogate for OS or as a direct measure of clinical benefits. For evaluating novel treatments for acute myeloid leukemia, EFS has been gradually recognized as a direct measure of clinical benefits. However, the application of an EFS endpoint is still controversial mainly due to the debate surrounding definition of treatment failure (TF) events. In this article, we investigate the EFS endpoint with the most conservative definition for the timing of TF, which is Day 1 since randomization. Specifically, the corresponding non-proportional hazard pattern of the EFS endpoint is investigated with both analytical and numerical approaches.     

后金融危机时期完善公允价值计量的探索

在2008年的金融风暴中,公允价值计量虽然暴露出其固有缺陷,但目前仍不失为一种面对市场的、动态反映产权价值运动的最佳计量模式。在后金融危机时期,我们需要通过建立健全市场机制、降低公允价值计量的实际操作难度、完善估值技术等手段进一步修改与完善公允价值计量模式,助推经济复苏与调整。     

Job quality,industrial relations and the crisis in Europe

This paper reports results from recent Eurofound research on the impact of the crisis on industrial relations and working conditions in Europe, based on the output of Eurofound's European Working Conditions Observatory and European Industrial Relations Observatory and data from the European Working Conditions Survey. Overall, the crisis – even if it is sometimes difficult to separate the effect of the crisis from megatrends in working conditions and industrial relations – seems to have had an impact on both domains. With reference to industrial relations, the impact of the crisis has influenced actors, processes, and outcomes. Regarding working conditions, the results appear to be in line with the literature on the topic, which relates the crisis to an increase in job insecurity, a decrease in work intensity, in working hours, and in anti-social working time arrangements, and a general improvement in terms of health risks and related outcomes.     

A general class of test statistics for Van Valen's Red Queen hypothesis

Van Valen's Red Queen hypothesis states that within a homogeneous taxonomic group the age is statistically independent of the rate of extinction. The case of the Red Queen hypothesis being addressed here is when the homogeneous taxonomic group is a group of similar species. Since Van Valen's work, various statistical approaches have been used to address the relationship between taxon age and the rate of extinction. We propose a general class of test statistics that can be used to test for the effect of age on the rate of extinction. These test statistics allow for a varying background rate of extinction and attempt to remove the effects of other covariates when assessing the effect of age on extinction. No model is assumed for the covariate effects. Instead we control for covariate effects by pairing or grouping together similar species. Simulations are used to compare the power of the statistics. We apply the test statistics to data on Foram extinctions and find that age has a positive effect on the rate of extinction. A derivation of the null distribution of one of the test statistics is provided in the supplementary material.     

Changes in the labour market and health inequalities during the years of the recent economic downturn in Italy

There is widespread concern that episodes of unemployment and unstable working conditions adversely affect health. We add to the debate by focusing on the relationship between work trajectory and the self-reported health of Italian men and women during the present economic downturn. Relying on Italian data in the EU-SILC project (from 2007 to 2010), our sample includes all individuals aged 30 to 60 in 2010, and uses multivariate binomial regression models for preliminary analyses and the Structural Equations modelling (SEM) to observe the cumulative effects of health status according to different job trajectories. Our main findings show similar pictures for men and women. Individuals who are unemployed, ejected or in precarious occupational positions have a higher risk of worsening their health status during these years.     

Corporate statement serving as information subsidies in the product-harm crisis

This study explores the attributes of a crisis statement which influence its utility as an information subsidy in the process of product-harm crises in China. Through investigating and analyzing 92 statements released in times of product-harm crises, the results show that the form in which the statement is released, and the length of the statement have significant effects on whether the statement will be quoted fully or partially by the news media.     

欧洲债务危机的主要成因分析

肇始于希腊的欧洲债务危机到目前为止都没有停息的迹象,甚至还呈蔓延之势。欧洲债务危机爆发的直接原因是在金融危机的背景下,政府支出规模持续扩大,导致财政赤字居高不下,最终使得国债规模超过政府的偿还能力,出现明显的违约可能性。同时,国际竞争力不足,导致出口受阻,使得资金问题更加严重。从更深层次看,产业结构不合理,经济发展速度缓慢,过低的投资率和储蓄率及过高的储蓄投资转化率,都是导致欧债危机的重要原因。     

20世纪60年代美国社会危机的治理对策及启示

20世纪60年代,美国爆发了大规模的社会运动,美国社会受到强烈的震动,但却并未因此走向完全的无序。通过法治手段、社会改革以及公民社会的发展,美国社会逐渐实现了由乱到治的转变。这表明,有效的社会制度安排,顺应民意和时代发展要求的社会改革,社会民主参与性的强化,对于化解社会危机,维护社会稳定具有积极的意义。     

论海外华人网文中的感伤情结与忧患意识——以“寒胭”作品为例

海外华人的网络写作越来越普遍,大多以非功利的＂民间＂立场、＂性灵性＂写作特点与多元文化视角独树一帜。网名＂寒胭＂者写作中对家国文化传承、城市现代化进程、人性变异与现代人精神实质的追溯与揭示颇具代表性,其感伤情结、家国情怀和忧患意识体现于哀国、殇城、感人、忧世四个方面。此类写作的意义在于,当一个民族身为＂弱国＂的历史未过百年,被强势文化浸濡的现状尚在延续,物质的发展建构在一定道德文明代价的付出之上,而多数人已在现代化进程中麻痹自满时,作为愈是远离而乡情愈重的海外儿女,他们的民族危机意识对＂人的存在＂与＂现代化＂真正涵义的质询与考辨,无论是对于祖国民族道德传承,还是精神物质文明建构,均有着弥足轻重的镜鉴意义。     

The Food Crisis and its Impacts on Poverty in Senegal and Mali: Crossed Destinies

This article uses two CGE macro‐micro models to analyse the distributional impact of the food crisis and policy responses in two neighbouring African countries, both of which are strongly dependent on agriculture. The approach captures structural differences at both the macro and micro level for household income and expenditure structures, and the results reveal differences for poverty impact at the national and sub‐group levels, as well as for inequality and pro‐poor analysis. The importance of country‐specific analysis and the risk of extrapolating conclusions from one country to another are also highlighted.