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41.
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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.  相似文献   
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Review of Managerial Science - According to basic finance theory, a derivative’s price is derived from the value of its underlying asset and therefore incorporates the same informational...  相似文献   
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The opportunity to use one's skills at work is an important prerequisite for employee well-being. Drawing on self-determination and person-environment fit theory, this diary study aims to add to our understanding of this important phenomenon in two ways. Firstly, we examine the associations of within-subject daily variations in skill utilization with well-being. Secondly, we model work value orientation as a between-subject factor that moderates this within-subject relationship. Specifically, we advocate that daily skill utilization is more beneficial (in terms of more daily work engagement and less daily emotional exhaustion) for employees holding predominantly intrinsic (i.e. self-development, community contribution) as opposed to extrinsic (i.e. financial success, status) values. Results of multilevel modelling using diary data from 99 service workers over five working days, supported the assumption that daily skill utilization was positively related to daily work engagement, particularly among employees holding a predominantly intrinsic work value orientation. Contrary to our expectations, daily skill utilization was unrelated to daily exhaustion, both for employees holding high and low intrinsic values. The discussion highlights the importance of, and employees’ receptiveness to, variations in beneficial working conditions.  相似文献   
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On the one hand, kernel density estimation has become a common tool for empirical studies in any research area. This goes hand in hand with the fact that this kind of estimator is now provided by many software packages. On the other hand, since about three decades the discussion on bandwidth selection has been going on. Although a good part of the discussion is about nonparametric regression, this parameter choice is by no means less problematic for density estimation. This becomes obvious when reading empirical studies in which practitioners have made use of kernel densities. New contributions typically provide simulations only to show that the own selector outperforms some of the existing methods. We review existing methods and compare them on a set of designs that exhibit few bumps and exponentially falling tails. We concentrate on small and moderate sample sizes because for large ones the differences between consistent methods are often negligible, at least for practitioners. As a byproduct we find that a mixture of simple plug-in and cross-validation methods produces bandwidths with a quite stable performance.  相似文献   
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We provide a new view on the nature of the gender wage gap (GWG) by analyzing the wage differentials within establishments. Based on linked employer–employee data for Germany, we show that the GWGs vary tremendously across establishments, even if we assume that male and female employees have the same human capital characteristics within each establishment. This heterogeneity is linked to firm and institutional characteristics: For instance, firms with works council and those covered by collective wage agreements have smaller GWGs. Furthermore, we find some evidence that firms operating under strong product market competition behave in a more egalitarian way.  相似文献   
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Alcohol intoxication, sexual arousal, and negative emotional states have been found to precede certain sexual behaviors. Using data from an online self-report survey distributed to adults (N = 717; 423 men and 304 women), we compared adults with adult online sexual interactions (n = 640; 89.3%) to adults with interactions with a child or an adolescent (n = 77; 10.7%) on how much they reported being affected by the following factors surrounding the time of the interactions: alcohol intoxication, sexual arousal, sadness, boredom, stress, and shame. We found that those with a child or adolescent contact reported higher sexual arousal and more shame before the interaction, compared with those with an adult contact. In addition, the levels of negative emotional states varied when levels before the interactions were compared with levels after the interactions, suggesting that engaging in online sexual interactions alleviated negative emotional states, at least temporarily. The alleviatory effects, however, were accompanied by higher levels of shame after the interactions. Overall, adults that engage in online sexual interactions have remarkably similar perceptions of the situation surrounding these activities, independent of the age of their online contacts. Limitations of the study are discussed.  相似文献   
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To examine whether high moral reasoning competence of adolescents is associated with low levels of bullying, and to understand whether moral disengagement mediates or moderates this relationship, 925 German children ranging from 11 to 17 years of age (M = 14.18, SD = 1.21) completed questionnaires on moral reasoning competence and moral disengagement in surveys at three different schools. The children were classified according to their bullying role, based on a peer‐nomination procedure. Multinomial logistic regression analyses showed that moral reasoning competence negatively predicted whether a student took an aggressive role. Moral disengagement partially mediated this relationship. Corresponding effects for defenders and outsiders were not found. These results extend previous findings about the effect of moral reasoning on bullying in primary school. The implications for the prevention of bullying are discussed.  相似文献   
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