A case study in identifying targeted patients population in major depressive disorder by enhanced enrichment design

Despite advances in clinical trial design, failure rates near 80% in phase 2 and 50% in phase 3 have recently been reported. The challenges to successful drug development are particularly acute in central nervous system trials such as for pain, schizophrenia, mania, and depression because high‐placebo response rates lessen assay sensitivity, diminish estimated treatment effect sizes, and thereby decrease statistical power. This paper addresses the importance of rigorous patient selection in major depressive disorder trials through an enhanced enrichment paradigm. This approach led to a redefinition of an ongoing, blinded phase 3 trial algorithm for patient inclusion (1) to eliminate further randomization of transient placebo responders and (2) to exclude previously randomized transient responders from the primary analysis of the double blind phase of the trial. It is illustrated for a case study for the comparison between brexpiprazole + antidepressant therapy and placebo + antidepressant therapy. Analysis of the primary endpoint showed that efficacy of brexpiprazole versus placebo could not be established statistically if the original algorithm for identification of placebo responders was used, but the enhanced enrichment approach did statistically demonstrate efficacy. Additionally, the enhanced enrichment approach identified a target population with a clinically meaningful treatment effect. Through its successful identification of a target population, the innovative enhanced enrichment approach enabled the demonstration of a positive treatment effect in a very challenging area of depression research.     

Are More Competent Workers More Satisfied?

Abstract. In this paper, we analyse the relationship between workers' competencies and their job satisfaction in the context of dual (i.e. vocational versus communicative) skill demands. We analyse the effects of workers' competencies on their overall, intrinsic, and extrinsic job satisfaction. We focus on pharmacy assistants who need both pharmaceutical and communicative competencies in their work. Results from a linked employer–employee survey show that assistants with more communicative competencies are more satisfied with their job, whereas assistants with more pharmaceutical competencies are not more satisfied than the less competent assistants. In addition, workers who perform tasks below their level of competence are more dissatisfied with both their remuneration and career prospects and the content of their job as such, than were other workers. Our results indicate that the demand shift from vocational towards communication skills, which occurs in many professions, can affect the job satisfaction of the most competent workers.     

Is religion a health resource for the poor?

This paper uses data from the 2004 General Social Survey to examine the relationship between religious belief and practice (religiosity), spirituality, social support, and health status. Health status is conceptualized first in terms of a subjective assessment and, second, as two objective indicators of physical problems. These relationships were examined first within the total GSS sample, and then separately for respondents who reported below or above the median annual income. Results indicate that spirituality is a positive predictor of respondents’ subjective assessment of their health in the overall sample, but not in either separate income group. Social support does not predict positive subjective or objective health outcomes in the entire sample or for any income group. However, religiosity is a positive predictor of physical health, but only for the most severe of the physical health problems measured, and only for respondents whose annual income is below the national median. Thus, it appears that religiosity is a health resource for those below average income.     

Ecologies of Boundaries: Modes of Boundary Work in Professional Proto‐Jurisdictions

Ecological approaches to professional work, authority, and regulation have seen a resurgence in the sociology of professions, as epitomized in the linked ecologies framework of Andrew Abbott. Alongside this resurgence comes a renewed attention to the way symbolic and material boundaries within and between professions, as well as between professional, university, and political institutions, come to be defined, negotiated, and changed as part of ongoing professional projects. Building on and comparing case studies set in Denmark into three emerging professional “proto‐jurisdictions”—of water‐related climate adaptation, lifestyle disease prevention, and innovation management—this article identifies three key modes of interprofessional boundary work important for such projects. In doing so, it grounds Abbott's meso‐level framework of linked ecologies in more situated accounts of workplace‐level boundary interaction, by reconnecting to a wider tradition of symbolic interactionist studies of professions.     

Eigenverantwortung — Berufliche Leistung und Anforderung

Ohne Zusammenfassung     

Impact of the reversal of the migration situation on the social structures of certain countries: the case of Italy

During the past 20 years, Italy has changed from being a country with well-established traditions of emigration to a country of destination. Italy had achieved 1 of the highest economic growth rates in the world. Conditions in Italy are favorable for hundreds of thousands of immigrants from developing countries. Most immigrants settle in large cities and in the South; most are in Italy illegally, performing jobs which Italians do not want. The Act n.943 of January 27, 1987, 1 of the most advanced and most liberal unilateral legal texts has 2 sections: 1) the 1st section establishes regulations governing the admission and residence of foreigners and conditions under which they may enter employment and 2) the 2nd section concerns the regularization of all situations involving the illegal presence of the hundreds of thousands of workers who arrived in Italy before 1987. During the 1st year of implementation, the Act proved to be ideologically enviable but unsuitable in practice. Specifically, Italian consulates in developing countries have received very few applications for permanent residence permits, while clandestine immigration is continuing. Also, only about 14% of clandestine immigrants who arrived before 1987 have regularized their situations. Insufficient information and excessive red tape in the regularization procedures contributed to these results. However, the fundamental cause of failure is economic: migrants know that regularization would keep them out of the labor market and be followed by loss of job and unemployment. Italians are uninterested in the role of immigrants as new members of society; the migrants, in turn, do everything possible not to draw attention to their presence and their diversity. Still, most Italians view immigrants with suspicion. To prepare for the future, account must be taken of possible fluctuations in the economic situation of expanding receiving countries and of the impact which these fluctuations may have on the degree of acceptance of immigrants. To solve these problems Italy must, 1) have a rational, realistic, and comprehensive approach to medium-term planning;2) use official development assistance to carry out labor-intensive projects in the partner country, to reduce the pressure to migrate; 3) base the planning of migration policy on the establishment of admission criteria for immigrants; 4) treat immigrants fairly and promote integration that respects their cultural identity; and 5) achieve international and multilateral coordination and consultation for migration policies.     

Analysis of bivariate dichotomous data from a stratified two-stage cluster sample

In the health and social sciences, researchers often encounter categorical data for which complexities come from a nested hierarchy and/or cross-classification for the sampling structure. A common feature of these studies is a non-standard data structure with repeated measurements which may have some degree of clustering. In this paper, methodology is presented for the joint estimation of quantities of interest in the context of a stratified two-stage sample with bivariate dichotomous data. These quantities are the mean value π of an observed dichotomous response for a certain condition or time-point and a set of correlation coefficients for intra-cluster association for each condition or time period and for inter-condition correlation within and among clusters. The methodology uses the cluster means and pairwise joint probability parameters from each cluster. They together provide appropriate information across clusters for the estimation of the correlation coefficients.     

The determinants of opting for the German group taxation regime with regard to taxes on corporate profits

Forming a tax group for corporate and trade tax purposes in Germany has its advantages in terms of tax savings for the companies concerned. Depending on the profit situation, for certain companies these benefits were extended by the 2001 German corporate tax reform. However, setting up a tax group in Germany is also accompanied by certain disadvantages for the consolidated companies, resulting especially from the assumption of increased liability for subsidiaries’ losses. The objective of this study is to investigate the factors determining the decision in favour of, or against, the formation of a tax group. A natural experiment arising from the 2001 German corporate tax reform allowed us to determine to what extent companies exploited the increased potential benefits of a tax group post reform. We test this finding employing firm-level data from the database AMADEUS. Our results show that the number of tax groups increased significantly with the introduction of the exemption method as from 01.01.2001. This result is especially apparent amongst companies benefiting from a tax group only post reform. Yet eligible companies which would have obtained tax benefits by entering into a tax group did not always choose this option. This applies in particular to parent companies with subsidiaries that are not wholly owned, and to small subsidiaries.     

Religious tattoos at one Christian university

More than one quarter of Americans now have tattoos. The proportion is even higher among younger adults. Tattoos express affiliation and identity. For some, tattoos also express religiosity. Very little research exists on religious tattoos. The purpose of this study is to profile religious tattoos among students at one Christian university in the southwestern United States. We analysed 752 photos of tattoos on campus. One in five photos depicted an overt religious image or text. Men were more likely than women to have a religious tattoo. In addition, the size, placement, and direction of religious tattoos differed by gender. Men’s religious tattoos were larger in size and in more prominent places on their bodies. Women’s religious tattoos were smaller and in more easily concealed locations. We conclude with a discussion of the practical and theoretical implications of our findings.     

Valuation effects of corporate strategic transactions in the cleantech industry

This paper investigates capital market reactions to announcements of corporate strategic transactions in the clean technology, or cleantech, industry. Using the event study method in a multi-country setting, we exploit a dataset of 328 hand-collected announcements of mergers and acquisitions, joint ventures, and asset disposals that took place between 2001 and 2011. We provide strong evidence of significant wealth gains from cleantech deals. On average, cleantech companies earn significantly higher abnormal returns than non-cleantech companies, confirming the beneficial idiosyncrasies of the cleantech industry. These high premia are likely driven by government interventions that are believed to be a necessary pre-condition for development of clean technology. Alternatively, the premia are commanded by the acquisition of cutting-edge environmental innovations and the positive credibility spillover inherent in cleantech deals.