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.     

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.     

Gender differences in predictors of late-life health insurance knowledge

For many older adults having access to affordable health care is a major concern. The present study's goal was to examine what factors were related to individuals' knowledge of late-life health insurance. A total of 131 women and 116 men (all aged 55-71) answered questions about private, Medicare, Medigap, and long-term care insurances. In addition, they answered demographic, personality, and health status questions. Results revealed that different factors are related to men's and women's knowledge of late-life health insurance options implying genderspecific educational interventions would be more effective than current educational interventions.     

Gaining by giving? Peer research into service user and carer perceptions of inclusivity in Higher Education

Abstract

Service users and carers (SUAC) have made significant contributions to professional training in social work courses in Higher Education (HE) over the past decade in the UK. Such participation has been championed by government, academics and SUAC groups from a range of theoretical and political perspectives. Most research into the effectiveness of SUAC involvement at HE has come from the perspectives of academics and very little SUAC-led research exists. This qualitative peer research was led by two members of the University of Worcester’s SUAC group. Findings were that SUAC perceived their involvement brought benefits to students, staff, the University and the local community. Significant personal benefits such as finding a new support network, increased self-development and greater confidence to manage their own care were identified in ways that suggested that the benefits that can flow from SUAC involvement at HE are perhaps more far-reaching than previously recognised. Barriers to inclusion were less than previously reported in the literature and the humanising effects of SUAC involvement are presented as a partial antidote to an increasingly marketised HE culture.