A new long-term survival model with dispersion induced by discrete frailty

Lifetime Data Analysis - Frailty models are generally used to model heterogeneity between the individuals. The distribution of the frailty variable is often assumed to be continuous. However, there...     

Inference and Decision Making for 21st-Century Drug Development and Approval

ABSTRACT

The cost and time of pharmaceutical drug development continue to grow at rates that many say are unsustainable. These trends have enormous impact on what treatments get to patients, when they get them and how they are used. The statistical framework for supporting decisions in regulated clinical development of new medicines has followed a traditional path of frequentist methodology. Trials using hypothesis tests of “no treatment effect” are done routinely, and the p-value < 0.05 is often the determinant of what constitutes a “successful” trial. Many drugs fail in clinical development, adding to the cost of new medicines, and some evidence points blame at the deficiencies of the frequentist paradigm. An unknown number effective medicines may have been abandoned because trials were declared “unsuccessful” due to a p-value exceeding 0.05. Recently, the Bayesian paradigm has shown utility in the clinical drug development process for its probability-based inference. We argue for a Bayesian approach that employs data from other trials as a “prior” for Phase 3 trials so that synthesized evidence across trials can be utilized to compute probability statements that are valuable for understanding the magnitude of treatment effect. Such a Bayesian paradigm provides a promising framework for improving statistical inference and regulatory decision making.     

The Effect of Mergers and Acquisitions on Employees: Wealth Transfer,Gain‐Sharing or Pain‐Sharing?

This paper considers whether gains made by shareholders from corporate takeovers are achieved at the expense of employees, as proposed by the ‘wealth transfer’ perspective. It analyses the contribution of employee lay‐offs, along with employment and wage changes, to the takeover premium and abnormal share price movements. The analysis draws on a unique dataset of British takeovers, combining documentary, share price and accounting data. The results show that lay‐offs planned at the takeover have either no effect or adverse effects on shareholder returns. Wages growth is positively, not inversely, related to shareholder returns from the second year after the takeover, whilst positive employment changes have a similar effect in the following year. Closer scrutiny indicates that labour and shareholders share gains when the firm does well, but share pain when it does not. There is evidence, therefore, that labour and shareholder interests can be complementary, rather than antagonistic, after takeovers.     

Put to the test: For a new sociology of testing

In an age defined by computational innovation, testing seems to have become ubiquitous, and tests are routinely deployed as a form of governance, a marketing device, an instrument for political intervention, and an everyday practice to evaluate the self. This essay argues that something more radical is happening here than simply attempts to move tests from the laboratory into social settings. The challenge that a new sociology of testing must address is that ubiquitous testing changes the relations between science, engineering, and sociology: Engineering is today in the very stuff of where society happens. It is not that the tests of 21st-century engineering occur within a social context but that it is the very fabric of the social that is being put to the test. To understand how testing and the social relate today, we must investigate how testing operates on social life, through the modification of its settings. One way to clarify the difference is to say that the new forms of testing can be captured neither within the logic of the field test nor of the controlled experiment. Whereas tests once happened inside social environments, today’s tests directly and deliberately modify the social environment.     

The price of a loaf of bread: some conceptions of family support*

This paper reports on a case study of one local authority, and illustrates the different definitions of the term ‘family support’ employed by the different agencies within the authority. It provides a framework to analyse the contribution of the agencies according to the assumptions they make about methods and efficacy of intervention and access to and termination of intervention. It contrasts the findings from this framework with a needs based model of ‘family support’. Social work and health services tend to operate within a narrow, historically determined range, focusing most heavily on emotional support and behavioural change; whereas users and some of the other agencies are more likely to raise matters such as income maintenance, child care, leisure and education. The findings of the case study are discussed in relation to resources for families, key issues for the implementation of family support identified during the introduction of the Children Act, 1989, and the relevance of Social Services Inspectorate inspections to these issues. Copyright © 2002 John Wiley & Sons, Ltd.     

Frustration in Infancy: Implications for Emotion Regulation,Physiological Processes,and Temperament

A study sample of 162 six‐month‐old children was selected from a larger sample of 346 infants on the basis of parents' report of their infants' temperament and a laboratory assessment of temperament. Infants were classified as easily frustrated and less easily frustrated and compared on a number of emotion regulation, physiology, and temperament measures. Results indicated that male and female infants were equally likely to be classified as frustrated and less easily frustrated; however, male infants were less able to regulate physiologically. Easily frustrated infants used different emotion regulation strategies and were observed to be less attentive and more active than less easily frustrated infants when observed in the laboratory. These infants were also characterized by their parents as more active, less attentive, and more distressed to novelty. Infants classified as easily frustrated were more reactive physiologically and less able to regulate physiological reactivity than their less easily frustrated counterparts. It is hypothesized that this cluster of characteristics may constitute a unique temperamental type that may have implications for other types of behavioral functioning. Limitations of the study are that observations are based on a single brief assessment of the infant, modest effect sizes were found, and the study is cross‐sectional.     

The Relationship Between Sense of Coherence and Career Thoughts

The authors examined the impact of sense of coherence on the career thought processes of a sample of college students. A. Antonovsky (1987) defined sense of coherence as the global orientation that the world is comprehensible, manageable, and meaningful. Study participants completed the Sense of Coherence Scale (A. Antonovsky, 1987) and the Career Thoughts Inventory (CTI; J. P. Sampson, G. W. Peterson, J. G. Lenz, R. C. Reardon, & D. E. Saunders, 1996). Multivariate tests indicated a medium relationship between sense of coherence and CTI Total and subscale scores; sense of coherence accounted for 14% of the variance. Univariate tests also indicated a medium relationship between sense of coherence and each subscale.     

Binding the Generations: Household Formation Patterns among Vietnamese Refugees1

Much of the analysis of refugee and immigrant adaptation has stressed the interaction of prior experience with the requirements of life in a new country. For refugees, that interaction has often been jarring because of the after‐effects of their flight and their relative inability to prepare for a new life in a new country. Yet refugees have often done rather well in economic terms in that new country. The reasons for that relative success have been phrased in cultural terms (e.g., the predisposition toward education) and in general socioeconomic terms (e.g., refugees as educated and skilled). This article examines a set of factors that lie between these customary cultural and socioeconomic categories. Specifically, the paper examines key features of household formation among Vietnamese refugees. An examination of historical data from southern Vietnam indicates patterns in household formation that appear durable over time yet are not shared across the breadth of Vietnam and cannot thus be viewed as “cultural” in the usual sense. A comparison of the historical data with recent national survey data on refugees in the United States indicates that these patterns continue among Vietnamese refugees and are ‐ as compared to other refugees ‐ distinctive to them. These patterns of household formation provide Vietnamese refugees with important options in adaptation to a new country.