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.     

Modelling of connected processes

The problem of comparing, contrasting and combining information from different sets of data is an enduring one in many practical applications of statistics. A specific problem of combining information from different sources arose in integrating information from three different sets of data generated by three different sampling campaigns at the input stage as well as at the output stage of a grey-water treatment process. For each stage, a common process trend function needs to be estimated to describe the input and output material process behaviours. Once the common input and output process models are established, it is required to estimate the efficiency of the grey-water treatment method. A synthesized tool for modelling different sets of process data is created by assembling and organizing a number of existing techniques: (i) a mixed model of fixed and random effects, extended to allow for a nonlinear fixed effect, (ii) variogram modelling, a geostatistical technique, (iii) a weighted least squares regression embedded in an iterative maximum-likelihood technique to handle linear/nonlinear fixed and random effects and (iv) a formulation of a transfer-function model for the input and output processes together with a corresponding nonlinear maximum-likelihood method for estimation of a transfer function. The synthesized tool is demonstrated, in a new case study, to contrast and combine information from connected process models and to determine the change in one quality characteristic, namely pH, of the input and output materials of a grey-water filtering process.     

Improved communality estimation in factor analysis

The symmetric treatment of an asymmetric approach to factor analysis is shown to provide accurate communality estimates. In comparison with existing estimates including upper and lower bounds, the present approach is shown to be superior. In one example with known communalities, the present approach perfectly captures those communalities. In two empirical examples, it is shown to produce better communality estimates than any existing method.     

Healthy Barbs: Activism Confronts Mortality

Barbara Brenner, JD, was the Executive Director of Breast Cancer Action (BCA) from 1995–2010. Before that, she was a longtime activist in the anti-war movement and an attorney who, for most of her career, practiced public policy law. After she was diagnosed with breast cancer in 1993 at the age of 41, she took the helm of BCA. Under her leadership, the organization moved into a position of national advocacy—demanding research on the causes and prevention of breast cancer, including the role of industrial pollutants. Barbara started the “Think Before You Pink” campaign, encouraging people to question whether companies that display pink ribbons actually produce products that harm women's health or generate any funds to fight breast cancer. Her blog, “Healthy Barbs,” challenged readers to critique routine healthcare practices and policies. Barbara received numerous awards, including a Jefferson Award for Public Service in 2007, the Smith College Medal in 2012, and the ACLU-Northern California's Lola Hanzel Courageous Advocacy Award in 2012. Barbara had a recurrence of breast cancer in 1996. She died of complications associated with amyotrophic lateral sclerosis, ALS, on May 10, 2013.     

奥巴马政府对朝政策的新理念及其走向

奥巴马政府上台后,其主要致力于应对金融危机和反恐战争.对朝政策上,其在"巧实力"外交理念的指导下,寻求在外交、经济、军事、政治、法律和文化等所有政策工具中选择正确的工具或组合.针对朝核问题的敏感性和脆弱性,奥巴马政府倾向于"冷处理",继而"多管齐下",在合作外交的框架内展开更加灵活的外交活动,促使朝鲜重返六方会谈,继续以对话方式处理相关问题,不过美国也适度增强了对朝鲜的威慑力量,奥巴马政府仍对美朝关系正常化持一种谨慎态度.     

建构一个新的城乡一体化分析框架：机会平等视角

对城乡一体化的现有研究或采用经济学视角,或采用制度学视角,而很少采用机会平等视角。研究认为:不论是经济资源配置还是制度和政策制定,都要视对城乡机会平等的影响如何,来判断其是否促进城乡一体化进程。机会平等是城乡一体化的本质属性。当然,机会是复杂、多样的,可以划分为基本生存机会、中层机会和高层机会,与此同时,平等也可以划分为形式平等和实质平等。在推进不同类型机会平等上,城乡一体化表现出不同的进度。该分析框架可以更好地分析我国城乡一体化进程(包括地区城乡一体化进程)。     

絮凝床在茂名热电厂含油污水处理系统中的应用

絮凝床是中山大学开发的一种新型水处理设备．这种水处理技术在我省已用于包括含动、植物油类的污水处理工程中，１９９６年我院首次把这种设备用于茂名热电厂合油（矿物油）污水处理，工程建成投产以来取得了令人满意的效果。     

Exploratory Study on Drug Users’ Perspectives on Quality of Life: More than Health-Related Quality of Life?

In drug treatment outcome literature, a focus on objective and socially desirable indicators of change (e.g. no drug use) has predominated, while outcome indicators that are important for drug users themselves (e.g. quality of life, satisfaction with treatment) have largely been neglected. Nonetheless, Quality of Life (QoL) has become an important concept to evaluate effectiveness of treatment in mental health care research and disability studies. Given the almost exclusive focus on Health-related Quality of Life (HRQOL) in substance abuse research and the neglect of clients’ perspectives in this field, we explore in this study the concept of QoL as perceived by drug users. Focus group discussions (n = 9) were organised in various treatment settings and community services for drug users in the region of Ghent, Belgium to identify important dimensions of QoL and their interpretation by drug users. Data were clustered and analysed based on the theoretical framework of Robert Schalock (Quality of life. Volume 1: Conceptualization and measurement, 1996). The domains ‘personal relationships’, ‘social inclusion’ and ‘self-determination’ were discussed most frequently by the participants. They stressed the importance of a supportive social network in particular. It can be concluded that QoL is not primarily associated by drug users with health and it involves much more than the aspects typically represented in measures of HRQOL.     

Emergency Law in China: Its Formation,Present State and Future

中国非常法律的形成, 是为了应对紧急事件。这类法律由法律法规、应急预案和 军事法规等组成, 规定了战争状态、紧急状态和应急状态三种非常状态, 致力于建构 专业化大分工基础上的综合统一体制。在实践中, 应急预案取代了法律法规, 成为紧 急事件治理的基本规范依据; 政府和武装力量处于主导地位。中国非常法律基于必要 而形成, 其适用具有临时性, 主要内容具有授权性和预防性。非常法律未来发展的主 要目标是: 与中国特色社会主义法律体系衔接, 制定紧急状态下的基本法, 完善非常 法律的各项具体机制。

关键词: 非常状态 综合治理 执行主导 预防性法律

China’s emergency laws have emerged as a result of dealing with crises. They comprise laws and regulations, emergency plans, and military regulations, and define three exceptional or emergency states: war, emergency and emergency response, with the aim of constructing a comprehensive integrated system based on the specialized division of labor. In practice, however, emergency plans take the place of laws and regulations and provide the fundamental normative basis for tackling emergencies, with government and the military playing the dominant role. Developing out of necessity and possessing temporary applicability, China’s emergency laws are characterized by authorization and prevention. Integrating emergency law with the socialist legal system with Chinese characteristics, formulating basic law for emergency situations and improving the specific mechanisms of emergency law should be regarded as major steps in its future development.     

Identification of Nonseparable Models Using Instruments With Small Support

I consider nonparametric identification of nonseparable instrumental variables models with continuous endogenous variables. If both the outcome and first stage equations are strictly increasing in a scalar unobservable, then many kinds of continuous, discrete, and even binary instruments can be used to point‐identify the levels of the outcome equation. This contrasts sharply with related work by Imbens and Newey, 2009 that requires continuous instruments with large support. One implication is that assumptions about the dimension of heterogeneity can provide nonparametric point‐identification of the distribution of treatment response for a continuous treatment in a randomized controlled experiment with partial compliance.