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.     

如何促进产业集群发展?——美国亚利桑那州产业集群发展模式分析

1980年代末至1990年代初,美国亚利桑那州经济遭遇严重衰退,地区经济发展面临转型压力。1992年,亚利桑那州实施了产业集群战略,成功推动了地区经济的复苏和转型,并使其成为之后十余年美国经济增长最快的地区之一。通过对亚利桑那州产业集群战略的制定、调整和集群发展特征的深入分析发现,亚利桑那州产业集群的发展得益于科学的战略设计和以"技术密集型中小企业+企业网络组织"为双驱动的发展模式,而政府在这一过程中只扮演着"组织者"和"协调者"的角色。这对中国产业集群的发展具有重要的借鉴意义。     

Media Disaster Reporting Effects on Public Risk Perception and Response to Escalating Tornado Warnings: A Natural Experiment

Previous research has evaluated public risk perception and response to a natural hazards in various settings; however, most of these studies were conducted either with a single scenario or after a natural disaster struck. To better understand the dynamic relationships among affect, risk perception, and behavioral intentions related to natural disasters, the current study implements a simulation scenario with escalating weather intensity, and includes a natural experiment allowing comparison of public response before and after a severe tornado event with extensive coverage by the national media. The current study also manipulated the display of warning information, and investigated whether the warning system display format influences public response. Results indicate that (1) affect, risk perception, and behavioral intention escalated as weather conditions deteriorated, (2) responses at previous stages predicted responses at subsequent stages of storm progression, and (3) negative affect predicted risk perception. Moreover, risk perception and behavioral intention were heightened after exposure to the media coverage of an actual tornado disaster. However, the display format manipulation did not influence behavioral responses. The current study provides insight regarding public perception of predisaster warnings and the influence of exposure to media coverage of an actual disaster event.     

Developing a Broadly Applicable Measure of Risk Perception

Decades of research identify risk perception as a largely intuitive and affective construct, in contrast to the more deliberative assessments of probability and consequences that form the foundation of risk assessment. However, a review of the literature reveals that many of the risk perception measures employed in survey research with human subjects are either generic in nature, not capturing any particular affective, probabilistic, or consequential dimension of risk; or focused solely on judgments of probability. The goal of this research was to assess a multidimensional measure of risk perception across multiple hazards to identify a measure that will be broadly useful for assessing perceived risk moving forward. Our results support the idea of risk perception being multidimensional, but largely a function of individual affective reactions to the hazard. We also find that our measure of risk perception holds across multiple types of hazards, ranging from those that are behavioral in nature (e.g., health and safety behaviors), to those that are technological (e.g., pollution), or natural (e.g., extreme weather). We suggest that a general, unidimensional measure of risk may accurately capture one's perception of the severity of the consequences, and the discrete emotions that are felt in response to those potential consequences. However, such a measure is not likely to capture the perceived probability of experiencing the outcomes, nor will it be as useful at understanding one's motivation to take mitigation action.     

Efficacy,Action, and Support for Reducing Climate Change Risks

A growing body of research demonstrates that believing action to reduce the risks of climate change is both possible (self‐efficacy) and effective (response efficacy) is essential to motivate and sustain risk mitigation efforts. Despite this potentially critical role of efficacy beliefs, measures and their use vary wildly in climate change risk perception and communication research, making it hard to compare and learn from efficacy studies. To address this problem and advance our understanding of efficacy beliefs, this article makes three contributions. First, we present a theoretically motivated approach to measuring climate change mitigation efficacy, in light of diverse proposed, perceived, and previously researched strategies. Second, we test this in two national survey samples (Amazon's Mechanical Turk N = 405, GfK Knowledge Panel N = 1,820), demonstrating largely coherent beliefs by level of action and discrimination between types of efficacy. Four additive efficacy scales emerge: personal self‐efficacy, personal response efficacy, government and collective self‐efficacy, and government and collective response efficacy. Third, we employ the resulting efficacy scales in mediation models to test how well efficacy beliefs predict climate change policy support, controlling for specific knowledge, risk perceptions, and ideology, and allowing for mediation by concern. Concern fully mediates the relatively strong effects of perceived risk on policy support, but only partly mediates efficacy beliefs. Stronger government and collective response efficacy beliefs and personal self‐efficacy beliefs are both directly and indirectly associated with greater support for reducing the risks of climate change, even after controlling for ideology and causal beliefs about climate change.     

Confidence intervals,significance values,maximum likelihood estimates,etc. sharpened into Occam’s razors

Abstract

Confidence sets, p values, maximum likelihood estimates, and other results of non-Bayesian statistical methods may be adjusted to favor sampling distributions that are simple compared to others in the parametric family. The adjustments are derived from a prior likelihood function previously used to adjust posterior distributions.     

Myriad potential for mentoring: Understanding the process of transformational change through a gender equality intervention

This article contributes to understanding transformational change towards gender equality by examining the transformational change potential of a mentoring programme for women, a type of gender equality intervention both criticized and praised for its ability to bring about change. Drawing upon an empirical case study of a mentoring programme for women academics in a Dutch university, we explore three dimensions of transformational change: organizational members (i) discussing and reflecting upon gendered organizational norms and work practices; (ii) creating new narratives; and (iii) experimenting with new work practices. Our findings indicate five specific conditions that enable transformational change: cross‐mentoring, questioning what is taken for granted, repeating participation and individual stories, facilitating peer support networks and addressing and equipping all participants as change agents. We suggest that these conditions should be taken into account when (re)designing effective organizational gender equality interventions.     

Robust Designs in Generalized Linear Models: A Quantile Dispersion Graphs Approach

This article studies design selection for generalized linear models (GLMs) using the quantile dispersion graphs (QDGs) approach in the presence of misspecification in the link and/or linear predictor. The uncertainty in the linear predictor is represented by a unknown function and estimated using kriging. For addressing misspecified link functions, a generalized family of link functions is used. Numerical examples are shown to illustrate the proposed methodology.