Active‐controlled,non‐inferiority trials in oncology: arbitrary limits,infeasible sample sizes and uninformative data analysis. Is there another way?

In oncology, it may not always be possible to evaluate the efficacy of new medicines in placebo-controlled trials. Furthermore, while some newer, biologically targeted anti-cancer treatments may be expected to deliver therapeutic benefit in terms of better tolerability or improved symptom control, they may not always be expected to provide increased efficacy relative to existing therapies. This naturally leads to the use of active-control, non-inferiority trials to evaluate such treatments. In recent evaluations of anti-cancer treatments, the non-inferiority margin has often been defined in terms of demonstrating that at least 50% of the active control effect has been retained by the new drug using methods such as those described by Rothmann et al., Statistics in Medicine 2003; 22:239-264 and Wang and Hung Controlled Clinical Trials 2003; 24:147-155. However, this approach can lead to prohibitively large clinical trials and results in a tendency to dichotomize trial outcome as either 'success' or 'failure' and thus oversimplifies interpretation. With relatively modest modification, these methods can be used to define a stepwise approach to design and analysis. In the first design step, the trial is sized to show indirectly that the new drug would have beaten placebo; in the second analysis step, the probability that the new drug is superior to placebo is assessed and, if sufficiently high in the third and final step, the relative efficacy of the new drug to control is assessed on a continuum of effect retention via an 'effect retention likelihood plot'. This stepwise approach is likely to provide a more complete assessment of relative efficacy so that the value of new treatments can be better judged.     

Women–Family in Quality Perspective

Bringing together women and family in quality perspective bring about interesting discussions in this paper. By integrating previous studies and considering expert opinions, we determinate the variables and dimensions with respect to women’s existence regarding their roles both in the family and at work. Many activities carried out by women represent the consumer aspects of their role. Women undertake these activities to fulfill their needs, which can be classified in the order of preference using Maslow’s Hierarchy of Need. Women success can be measured based on their ability to perform their roles successfully. We identify women’s performance by using quality approach of Personal Quality Maintenance (PQM), which is widely applied in many organizations in order to maintain the service delivery, which meets the customer satisfaction. The effort to enhance women’s satisfaction for their success in playing the multirole in the family and at work is our main consideration. This study may contribute a new point of view regarding for the women’s welfare and existence.     

Age at marriage and marital instability: revisiting the Becker–Landes–Michael hypothesis

An early age at first marriage is known to be associated with a high risk of divorce. Yet, it has been suggested that beyond a certain point, the relationship between age at marriage and marital instability may become positive because as unmarried women begin to hear their biological clock tick, they may settle for matches far from the optimal. Analyses based on cycles 5 and 6 of the National Surveys of Family Growth show that the relationship between age at marriage and marital instability is strongly negative up to the late 20s, with a flattening of the curve thereafter.

Testing Evolutionary Hypotheses with Demographic Data

An ecological evolutionary viewpoint offers new perspectives on contemporary demographic problems in general and on population–environment issues in particular. In turn, rich and detailed human demographic data can help solve problems of interest in evolutionary theory. Such data have been analyzed in greatest detail in studies of traditional and historical societies. Evolutionary approaches using historical data go beyond small‐sample anthropological studies to the application of the evolutionary approach to large datasets, and illuminate important similarities between small‐scale traditional societies and large modern populations living in evolutionarily novel environments. This article provides a concise update of the breadth of questions and hypotheses of likely interest to demographers and others that evolutionary theorists address using a variety of traditional and historical datasets. It suggests opportunities for additional collaborative work between evolutionary theorists and historical demographers and highlights topics relevant to modern demography.     

Editors' Introduction

Population Research and Policy Review -     

Employment and earnings of foreign-born scientists and engineers

Population Research and Policy Review -     

Child and Youth Well-Being in the United States, 1975–1998: Some Findings from a New Index

Social Indicators Research - This paper addresses the following questions: Overall, on average, how did child and youthwell-being in the United States of Americachange in the last quarter of the...     

Childhood family structure and young adult behaviors

This paper examines a wide variety of forms, and full histories, of family structure to test existing theories of family influences and identify needs for new theories. The focus is on links between childhood family structure and both completed schooling and risk of a nonmarital birth. Using a 27-year span of panel (PSID) data for U.S. children, we find that: (a) change is stressful, (b) timing during childhood is relevant, (c) adults other than parents are important, and (d) two more recently studied family structures (mother-with-grandparent(s) and mother-with-stepfather) do not fit the molds of existing theories. The findings suggest that new theories should consider allocation of resources and reasons people group into family structures. Received: 11 September 1998/Accepted: 27 March 2000