Selection bias for treatments with positive Phase 2 results

In drug development, treatments are most often selected at Phase 2 for further development when an initial trial of a new treatment produces a result that is considered positive. This selection due to a positive result means, however, that an estimator of the treatment effect, which does not take account of the selection is likely to over‐estimate the true treatment effect (ie, will be biased). This bias can be large and researchers may face a disappointingly lower estimated treatment effect in further trials. In this paper, we review a number of methods that have been proposed to correct for this bias and introduce three new methods. We present results from applying the various methods to two examples and consider extensions of the examples. We assess the methods with respect to bias of estimation of the treatment effect and compare the probabilities that a bias‐corrected treatment effect estimate will exceed a decision threshold. Following previous work, we also compare average power for the situation where a Phase 3 trial is launched given that the bias‐corrected observed Phase 2 treatment effect exceeds a launch threshold. Finally, we discuss our findings and potential application of the bias correction methods.     

Label‐ and Level‐Invariant Graphical Log‐Linear Models

We introduce two types of graphical log‐linear models: label‐ and level‐invariant models for triangle‐free graphs. These models generalise symmetry concepts in graphical log‐linear models and provide a tool with which to model symmetry in the discrete case. A label‐invariant model is category‐invariant and is preserved after permuting some of the vertices according to transformations that maintain the graph, whereas a level‐invariant model equates expected frequencies according to a given set of permutations. These new models can both be seen as instances of a new type of graphical log‐linear model termed the restricted graphical log‐linear model, or RGLL, in which equality restrictions on subsets of main effects and first‐order interactions are imposed. Their likelihood equations and graphical representation can be obtained from those derived for the RGLL models.     

Statutory leave entitlements across developed countries: Why US workers lose out on work–family balance

Using a composite index of legal provisions for annual and family leave in western Europe, the United States, Canada, Australia, Japan and the Republic of Korea, the authors rank legislative support for this aspect of work–family balance. The United States ranks last: its employers are not required to grant annual leave and employees can take no more than 12 weeks' family leave per year. The United States' comparatively low labour standards, the authors argue, may be due to the dominance of a market‐based conception of employment and the assumption of equal employer–employee bargaining power, neither of which is fully shared by the other industrialized democracies.     

LENDING RELATIONSHIPS AND MONETARY POLICY

Financial intermediation and bank spreads are the important elements in the analysis of business cycle transmission and monetary policy. We present a simple framework that introduces lending relationships, a relevant feature of financial intermediation that has been so far neglected in the monetary economics literature, into a dynamic stochastic general equilibrium model with staggered prices and cost channels. Our main findings are (a) banking spreads move countercyclically generating amplified output responses, (b) spread movements are important for monetary policymaking even when a standard Taylor Rule is employed, (c) modifying the policy rule to include a banking spread adjustment improves stabilization of shocks and increases welfare when compared to rules that only respond to output gap and inflation, and finally (d) the presence of strong lending relationships in the banking sector can lead to indeterminacy of equilibrium forcing the Central Bank to react to spread movements. (JEL E44, E52, G21)     

Toward Mutual Support: A Task Analysis of the Relational Justice Approach to Infidelity

Gender, culture, and power issues are intrinsic to the etiology of infidelity, but the clinical literature offers little guidance on how to work with these concerns. The Relational Justice Approach (RJA) to infidelity (Williams, Family Process, 2011, 50, 516) uniquely places gender and power issues at the heart of clinical change; however, this approach has not been systematically studied. Therefore a qualitative task analysis was utilized to understand how change occurs in RJA. The findings indicated four necessary tasks: (a) creating an equitable foundation for healing, (b) creating space for alternate gender discourse, (c) pursuing relational responsibility of powerful partner, and (d) new experience of mutual support. Therapists' attention to power dynamics that organize couple relationships, leadership in intervening in power processes, and socio‐cultural attunement to gender discourses were foundational to this work. These findings help clarify the processes by which mutual healing from the trauma of infidelity may occur and offer empirically based actions that therapists can take to facilitate mutual support.     

Reviews

The Jewish Anti‐Fascist Committee Revisited. Alexander M. Borschtschagowski, Orden für einen Mord: Die Judenverfolgung unter Stalin. Berlin: Propyläen, 1997. Notes. Ind. Glossary. 472pp. ISBN 3–549–05605–2 (hbk)

Arno Lustiger, Rotbuch: Stalin und die Juden. Die tragische Geschichte des Jüdischen Antifaschistischen Komitees und der sowjetischen Juden. With a foreword by Efim Etkind. Berlin: Aufbau‐Verlag, 1998. Bibl. Notes. Ind. Photographs. 429pp. ISBN 3–351–02478–9 (hbk)

A Chicken‐and‐Egg Situation. Charles King and Neil J. Melvin (eds.), Nations Abroad: Diaspora Politics and International Relations in the Former Soviet Union. Boulder, CO/Oxford: Westview Press, 1998. 240 pp. Index. ISBN 0–8133–9015‐X

A Greek Tragedy. Gennady Estraikh, Soviet Yiddish: Language Planning and Linguistic Development. Oxford: Clarendon Press, 1999. x + 217pp. Bibliography. Index. £40. ISBN: 0–19818479–0

Freeze‐Frame Picture. Susanne Marten‐Finnis and Heather Valencia. Sprachinseln. Jiddische Publizistik in London, Wilna und Berlin 1880–1930. Cologne/Weimar/Vienna: Böhlau Verlag, 1999. 144pp. Illustrations. Bibliography. ISBN: 3–412–02998‐X     

Direct practice with substance abusing mothers in the child welfare system: A system perspective

This paper explores the needs and related issues of substance abusing mothers in the child welfare system. Using a framework and through literature review, issues at the micro, mezzo, and macro levels are pinpointed. Six guidelines, incorporating these identified issues, are developed to help practitioners better engage and more effectively work with their clients: (1) treating mothers and children as one unit, (2) providing gender, mother role, and cultural sensitive practice, (3) offering life‐skills training, (4) mobilizing old and facilitating new, nonusing support systems, (5) devising safety plans for children, and (6) organizing an interdisciplinary team and assuming the leadership.