Inferences on the Means of Two Log-Normal Distributions: A Computational Approach Test

In this article, we propose a novel approach for testing the equality of two log-normal populations using a computational approach test (CAT) that does not require explicit knowledge of the sampling distribution of the test statistic. Simulation studies demonstrate that the proposed approach can perform hypothesis testing with satisfying actual size even at small sample sizes. Overall, it is superior to other existing methods. Also, a CAT is proposed for testing about reliability of two log-normal populations when the means are the same. Simulations show that the actual size of this new approach is close to nominal level and better than the score test. At the end, the proposed methods are illustrated using two examples.     

Statistical testing strategies for assessing treatment efficacy and marker accuracy in phase III trials

When a candidate predictive marker is available, but evidence on its predictive ability is not sufficiently reliable, all‐comers trials with marker stratification are frequently conducted. We propose a framework for planning and evaluating prospective testing strategies in confirmatory, phase III marker‐stratified clinical trials based on a natural assumption on heterogeneity of treatment effects across marker‐defined subpopulations, where weak rather than strong control is permitted for multiple population tests. For phase III marker‐stratified trials, it is expected that treatment efficacy is established in a particular patient population, possibly in a marker‐defined subpopulation, and that the marker accuracy is assessed when the marker is used to restrict the indication or labelling of the treatment to a marker‐based subpopulation, ie, assessment of the clinical validity of the marker. In this paper, we develop statistical testing strategies based on criteria that are explicitly designated to the marker assessment, including those examining treatment effects in marker‐negative patients. As existing and developed statistical testing strategies can assert treatment efficacy for either the overall patient population or the marker‐positive subpopulation, we also develop criteria for evaluating the operating characteristics of the statistical testing strategies based on the probabilities of asserting treatment efficacy across marker subpopulations. Numerical evaluations to compare the statistical testing strategies based on the developed criteria are provided.     

Blinded continuous monitoring in clinical trials with recurrent event endpoints

In studies with recurrent event endpoints, misspecified assumptions of event rates or dispersion can lead to underpowered trials or overexposure of patients. Specification of overdispersion is often a particular problem as it is usually not reported in clinical trial publications. Changing event rates over the years have been described for some diseases, adding to the uncertainty in planning. To mitigate the risks of inadequate sample sizes, internal pilot study designs have been proposed with a preference for blinded sample size reestimation procedures, as they generally do not affect the type I error rate and maintain trial integrity. Blinded sample size reestimation procedures are available for trials with recurrent events as endpoints. However, the variance in the reestimated sample size can be considerable in particular with early sample size reviews. Motivated by a randomized controlled trial in paediatric multiple sclerosis, a rare neurological condition in children, we apply the concept of blinded continuous monitoring of information, which is known to reduce the variance in the resulting sample size. Assuming negative binomial distributions for the counts of recurrent relapses, we derive information criteria and propose blinded continuous monitoring procedures. The operating characteristics of these are assessed in Monte Carlo trial simulations demonstrating favourable properties with regard to type I error rate, power, and stopping time, ie, sample size.     

Modifications of sequential designs in bioequivalence trials

Bioequivalence (BE) studies are designed to show that two formulations of one drug are equivalent and they play an important role in drug development. When in a design stage, it is possible that there is a high degree of uncertainty on variability of the formulations and the actual performance of the test versus reference formulation. Therefore, an interim look may be desirable to stop the study if there is no chance of claiming BE at the end (futility), or claim BE if evidence is sufficient (efficacy), or adjust the sample size. Sequential design approaches specially for BE studies have been proposed previously in publications. We applied modification to the existing methods focusing on simplified multiplicity adjustment and futility stopping. We name our method modified sequential design for BE studies (MSDBE). Simulation results demonstrate comparable performance between MSDBE and the original published methods while MSDBE offers more transparency and better applicability. The R package MSDBE is available at https://sites.google.com/site/modsdbe/ . Copyright © 2015 John Wiley & Sons, Ltd.     

质押——个人住房消费贷款的一种制度创新

文章分析了推行个人住房消费质押贷款的优势和可行性,探讨了可以用来作为住房质押贷款的质物和住房消费质押贷款的运作机制,最后指出了个人住房消费质押贷款能顺利运作所必须的支撑体系.     

"民官比"不是影响政治体制改革的重要因素

在政治体制改革中,公务员或国家干部人数的多少并不是一个关键因素,重要的是必须把政府的社会定位(包括角色、权力和责任)划分清楚。与世界各国相比较,我国197.69∶1(或116.27∶1)的“民官比”并不高,因此,今后的政治体制改革不需要再把精力集中在“精简”上,而应按邓小平的部署,首先把党政分开和权力下放的工作做好。毕竟“小政府”是指“政府权力受限制”,而非“人数更少”;“大社会”是指“社会权利更广泛”,而非“人数更多”。     

经济适用住房成本控制体系问题及对策

本文从总结现阶段经济适用房建设的基本模式入手,分析了经济适用房建设中住房成本控制体系中存在的主要问题及其原因,最后提出了若干对策。     

关于商品房购买者的特殊消费者地位问题

确立商品房购买者的特殊消费者地位是消费者权益保护按规律发展的客观体现,是我国房地产业走向成熟的必然结果。确立商品房购买者消费者地位的法律后果体现为商品房购买者享有消费者的各项权益,也体现为商品房经营者承担侵害消费者合法权益的法律责任。     

Determinants of housing quality: A comparison of white,African-American,and Hispanic single-parent women

This study examines housing quality among three groups of single-parent women: white, African-American, and Hispanic. Three indicators of housing quality—crowding, affordability, and satisfaction—are used to discover the extent to which these groups experience housing problems. This study also explores differences and similarities in the factors that precipitate problems in housing quality for these three groups of single parents. Findings suggest important differences and similarities in the nature of housing quality problems among white, African-American, and Hispanic single-parent women. The specified variables explained about 20% of the variance in crowding, housing affordability, and housing satisfaction. On measures of objective and subjective housing quality, white single mothers are better housed than their African-American or Hispanic counterparts. Hispanic single mothers have the largest housing cost burden and average more persons per household than the other groups. African-Americans are twice as likely as either group to live in low-quality housing and reported the lowest average satisfaction with their housing. Her research interests include housing and neighborhood assessment and women and public policy issues. She has recently published articles inUrban Affairs Quarterly andHousing and Society on housing and neighborhood assessment criteria among black urban households and the housing cost burden of various groups of female-headed households. She received her Ph.D. from Ohio State University. Her research interests include the housing adjustment behavior of women and public policy. She has recently completed her thesis on the role of noncustodial parents in determining the quality of life of their children. She is also the recipient of the Tessie Agan Award for research excellence from the American Association of Housing Educators for a paper titled “Unterstanding Constraints and Residential Satisfaction among Low-Income Single-Parent Families.”