The use of external controls: To what extent can it currently be recommended?

With more and better clinical data being captured outside of clinical studies and greater data sharing of clinical studies, external controls may become a more attractive alternative to randomized clinical trials (RCTs). Both industry and regulators recognize that in situations where a randomized study cannot be performed, external controls can provide the needed contextualization to allow a better interpretation of studies without a randomized control. It is also agreed that external controls will not fully replace RCTs as the gold standard for formal proof of efficacy in drug development and the yardstick of clinical research. However, it remains unclear in which situations conclusions about efficacy and a positive benefit/risk can reliably be based on the use of an external control. This paper will provide an overview on types of external control, their applications and the different sources of bias their use may incur, and discuss potential mitigation steps. It will also give recommendations on how the use of external controls can be justified.     

从规范理论到诊断实践

本文通过描述哲学中一种替代性的诊断实践,讲述了对伦理学与政治学中的规范性理论 活动的一种批判。它概述了这种实践从康德开始,通过马克思和尼采,直至福柯为止的演化过程,并 尝试通过将它与医学中的诊断实践进行对比,来识别其特征。在结论部分,文章提出,一种哲学形式 下的诊断实践的特殊要素,在于它对当前进行诊断时所需要的那些概念工具的关心,以及它对这种实 践在认识论上所固有的那些局限的关注。     

Epistemological problems and the personality and social system in social psychology

If we understand social psychology to be an area where sociology and psychology overlap, or more precisely where we try to explain interaction on the basis of psychological and sociological propositions and concepts, we have singled out a field that should be quite challenging not only in theory and method but in the fundamental questions it raises for both sociology and psychology. Actually, the discipline is not that well integrated and is constituted by such disparate approaches as reinforcement theory, field theory, role theory, small group theory, game theory and psychoanalysis. Many sociologists have abandoned the field altogether. Nor have the proponents of these sub-fields made much effort to consolidate, integrate or reconcile their methodologies. Epistemological questions have been notably absent and only now have arguments from the philosophy of science point of view reemerged to revive the critical and potentially fruitful methodological discussions of earlier theorists (F. Allport; Lewin; Mead; Simmel) and their more recent followers (Homans; Malewski). After considering epistemological problems dealing with the generality of theory and explanation, behavioristic vs. action approaches, operational and model structural implications, we want to argue for a better understanding of social system variables besides those of the personality system and of system theory in general. In our discussion we use examples from the area of sport because it composes a complex system, that is not too difficult to observe at the same time that it shows in relative clarity all of the different levels of an action system. It has, furthermore, many features of an almost experimental design in a natural field. In so far it is a model area to allow due consideration for our demand that social psychology rediscover the method of field studies. This will help to reverse the trend characterized by a general neglect of theory that has resulted from behavioral dogmatism and the expedience of research pragmatism based mostly on two-variable linear models. This is not to say that we disfavor rigorous research design and data analysis - to the contrary. We just want it to be done in the context of broader theoretical concerns and in clear recognition of the pitfalls of operationalism and the merits of action theory.     

How Studies of the Educational Progression of Minority Children Are Affecting Education Policy in Denmark

Over the past decade, the number of ethnic minorities in Denmark has increased rapidly, now accounting for over 8 per cent of the total population. This paper presents results from a number of recent studies regarding the educational choices of minority children from less developed countries. An important social concern is that the educational attainment of these children is much lower than among native Danes. The studies show that that a main reason for the education gap is very high dropout rates from vocational schools among minority children and that inadequate Danish language proficiency of immigrants, parents and their children, is an important reason for the high dropout rates, as are inadequate educational preparedness from grade school and insufficient apprenticeship positions available for minority youth. Socio‐economic background, however, has relatively little effect. Recent policy changes to reduce dropout rates from vocational schools are reviewed and additional policy interventions are proposed.     

No Switchbacks: Rethinking Aspiration-Based Dynamics in the Ultimatum Game

Aspiration-based evolutionary dynamics have recently been used to model the evolution of fair play in the ultimatum game showing that incredible threats to reject low offers persist in equilibrium. We focus on two extensions of this analysis: we experimentally test whether assumptions about agent motivations (aspiration levels) and the structure of the game (binary strategy space) reflect actual play, and we examine the problematic assumption embedded in the standard replicator dynamic that unhappy agents who switch strategies may return to a rejected strategy without exploring other options. We find that the resulting “no switchback” dynamic predicts the evolution of play better than the standard dynamic and that aspirations are a significant motivator for our participants. In the process, we also construct and analyze a variant of the ultimatum game in which players can adopt conditional (on their induced aspirations) strategies.     

Rule generation for categorical time series with Markov assumptions

Several procedures of sequential pattern analysis are designed to detect frequently occurring patterns in a single categorical time series (episode mining). Based on these frequent patterns, rules are generated and evaluated, for example, in terms of their confidence. The confidence value is commonly interpreted as an estimate of a conditional probability, so some kind of stochastic model has to be assumed. The model is identified as a variable length Markov model. With this assumption, the usual confidences are maximum likelihood estimates of the transition probabilities of the Markov model. We discuss possibilities of how to efficiently fit an appropriate model to the data. Based on this model, rules are formulated. It is demonstrated that this new approach generates noticeably less and more reliable rules.     

Bargaining cum voice

We propose a formal concept of the power of voice in the context of a simple model where individuals form groups and trade in competitive markets. Individuals use outside options in two different ways. Actual outside options reflect the possibility to exit or to join other existing groups. Hypothetical outside options refer to hypothetical groups that are ultimately not formed. Articulation of hypothetical outside options in the bargaining process determines the relative bargaining power of the members of a group, which constitutes an instance of the power of voice. The adopted equilibrium concept, competitive equilibrium with free group formation and bargaining cum voice, endogenizes the outside options as well as the power of voice. We establish existence of such equilibria and we explore their properties.     

From zero-sum to win-win - Organisational conditions for successful shared value strategy implementation

The number of publications on shared value strategies (SVSs) is continuously increasing. Literature does not answer the question which organisational conditions are necessary and which conjunctions of conditions are sufficient for the successful implementation of SVSs. This research aims at filling the gap by condensing empirical evidence found in the literature on successful SVSs, stakeholder management, corporate social responsibility, and positive social change. The article synthesises the findings of these streams of research into a set-theoretical framework and proposes five complex conditions necessary for successful SVS implementation: shared value-oriented entrepreneurial vision, strategic alignment (STA), shared value-oriented innovation (SVI), networking capabilities (NCs), and impact monitoring. Additional empirical evidence from cases claiming successful implementation of SVS allows the suggestion of several simple conditions constituting the complex conditions. Qualitative comparative analysis can be used for empirically testing the necessity of the suggested conditions and the sufficiency of conjunctions of complex conditions for SVS implementation success. The proposed framework enhances theoretical knowledge concerning successful SVS implementation and is an important step to support management efforts in reorienting their companies from zero-sum strategies to win-win SVSs.