Issues in applying recent CPMP ‘Points to Consider’ and FDA guidance documents with biostatistical implications

The International Conference on Harmonisation guideline ‘Statistical Principles for Clinical Trials’ was adopted by the Committee for Proprietary Medicinal Products (CPMP) in March 1998, and consequently is operational in Europe. Since then more detailed guidance on selected topics has been issued by the CPMP in the form of ‘Points to Consider’ documents. The intent of these was to give guidance particularly to non‐statistical reviewers within regulatory authorities, although of course they also provide a good source of information for pharmaceutical industry statisticians. In addition, the Food and Drug Administration has recently issued a draft guideline on data monitoring committees. In November 2002 a one‐day discussion forum was held in London by Statisticians in the Pharmaceutical Industry (PSI). The aim of the meeting was to discuss how statisticians were responding to some of the issues covered in these new guidelines, and to document consensus views where they existed. The forum was attended by industry, academic and regulatory statisticians. This paper outlines the questions raised, resulting discussions and consensus views reached. It is clear from the guidelines and discussions at the workshop that the statistical analysis strategy must be planned during the design phase of a clinical trial and carefully documented. Once the study is complete the analysis strategy should be thoughtfully executed and the findings reported. Copyright © 2003 John Wiley & Sons, Ltd.     

Land Ownership as a Determinant of Temporary Migration in Nang Rong, Thailand

In this study I consider landownership as a determinant of temporary migrationin a rural area of Thailand. Previous researchon rural areas in developing countries hasfocused on the use of migration to diversifyhousehold incomes across economic sectors andacross geographic areas. I combine thisliterature with economic theories of migrationto understand the effect of land ownership ontemporary migration of household members inNang Rong, Thailand. I estimate regressionmodels predicting the probability of ahousehold having any temporary migrants, andpredicting the number of male or femaletemporary migrants in the household. I findthat households with smaller landholdings arediversifying through migration in order tosupplement rural income, while households withlarger landholdings are diversifying in orderto overcome the absence of accessible credit inthe village.     

Poor Mothers and Habits of Hiding: Participatory Methods in Poverty Research

Poor mothers have long‐standing habits of hiding their lives in response to punitive authorities and stigma. We identify practices of hiding daily life, and we describe participatory research approaches for and ethical concerns in learning more about poor women's critical insights and survival strategies.     

刻意创新

我们大多数人都认同创新是成长的关键途径。问题是如何创新?许多企业依靠突发机遇。也就是说,他们指望某个人提出产品或服务方面的点子,然后从中获利。然而有些时候,企业必须发掘比以往更多的创意,并先于竞争对手将创意化为切实可行的产品与服务。此时,企业便不能再依靠机缘巧合了。我们需要可持续、可重复的创新方法。     

Identifying Latent Structures in Panel Data

This paper provides a novel mechanism for identifying and estimating latent group structures in panel data using penalized techniques. We consider both linear and nonlinear models where the regression coefficients are heterogeneous across groups but homogeneous within a group and the group membership is unknown. Two approaches are considered—penalized profile likelihood (PPL) estimation for the general nonlinear models without endogenous regressors, and penalized GMM (PGMM) estimation for linear models with endogeneity. In both cases, we develop a new variant of Lasso called classifier‐Lasso (C‐Lasso) that serves to shrink individual coefficients to the unknown group‐specific coefficients. C‐Lasso achieves simultaneous classification and consistent estimation in a single step and the classification exhibits the desirable property of uniform consistency. For PPL estimation, C‐Lasso also achieves the oracle property so that group‐specific parameter estimators are asymptotically equivalent to infeasible estimators that use individual group identity information. For PGMM estimation, the oracle property of C‐Lasso is preserved in some special cases. Simulations demonstrate good finite‐sample performance of the approach in both classification and estimation. Empirical applications to both linear and nonlinear models are presented.     

Effects of a single-lesson tobacco prevention curriculum on knowledge, skill identification and smoking intention

One in five students report experimenting with tobacco before the age of 13 and most prevention efforts take place in the school setting. This study measures the effect of a single-lesson tobacco prevention curriculum, conducted by a health education center, focusing on knowledge of tobacco, ability to identify refusal techniques, and intent not to smoke. Data were collected, via electronic keypads, from students visiting a non-school, health education center in Michigan (n = 704 intervention and 85 comparison). Contingency table Chi-squared tests and t-tests demonstrated that a single lesson can improve general knowledge and ability to identify appropriate refusal techniques. Improvement in intent not to smoke was not significant because both groups had very high intent prior to implementation. Similar to results from other programs, multivariate logistic regression of gender, general knowledge, and skill identification revealed that only the skill variable was associated with intent not to smoke at pretest. Recommendations are given for further research and for designing more effective curricula or programs.     

A League of Gentlemen: The Institute of the Motor Industry

The article first examines how a Victorian discourse of gentlemanliness has been used by the professions to support a claim to moral and intellectual superiority. In Bourdieusian terms, this allowed an emerging professional class to accumulate a stock of cultural capital that differentiated them from entrepreneurship and commerce. However, there has been dramatic increase in occupational groups claiming professional status. This includes the use of signifiers of gentility and respectability such as charters, coats of arms and prestigious headquarters. The particular artefacts produced by the Institute of the Motor Industry (IMI), a professional body that represents car dealers and repair shops, are examined and related to Theodor Adorno’s concept of the culture industry wherein social markers have become manufactured effects that can be exchanged. They have thus been emptied out of meaning as a claim to gentlemanly status has been reduced to the possession of certain objects rather than a set of particular behaviours.     

Clinical Social Work and Psychoanalysis: Introduction to the Special Issue

As clinical social work developed in America it was highly influenced by the concepts and techniques of psychoanalysis and many of its practitioners became interested in seeking psychoanalytic training. More and more psychoanalysts are now coming from a background in clinical social work due to the development of a network of interdisciplinary training institutes and the opening of the Institutes of the American Psychoanalytic Association to non-medical candidates. This special issue considers how psychoanalysis may be affected as more of its practitioners and contributors come from a background in clinical social work. This introduction reviews the history of the development of clinical social work and outlines the issues related to “lay analysis” in this country.

Best practices for online Canadian prenatal health promotion: A public health approach

Background

Prenatal health promotion provides information regarding pregnancy risks, protective behaviours and clinical and community resources. Typically, women obtain prenatal health information from health care providers, prenatal classes, peers/family, media and increasingly, Internet sites and mobile apps. Barriers to prenatal health promotion and related services include language, rural/remote location, citizenship and disability. Online public health platforms represent the capacity to reach underserved women and can be customised to address the needs of a heterogeneous population of pregnant women.