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In the 1960s, W. B. Rosen conducted some remarkable experiments on unidirectional fibrous composites that gave seminal insights into their failure under increasing tensile load. These insights led him to a grid system where the nodes in the grid were ineffective length fibers and to model the composite as something he called a chain‐of‐bundles model (i.e., a series system of parallel subsystems of horizontal nodes that he referred to as bundles), where the chain fails when one of the bundles fails. A load‐sharing rule was used to quantify how the load is borne among the nodes. Here, Rosen's experiments are analyzed to determine the shape of a bundle. The analysis suggests that the bundles are not horizontal collection of nodes but rather small rectangular grid systems of nodes where the load‐sharing between nodes is local in its form. In addition, a Gibbs measure representation for the joint distribution of binary random variables is given. This is used to show how the system reliability for a reliability structure can be obtained from the partition function for the Gibbs measure and to illustrate how to assess the risk of failure of a bundle in the chain‐of‐bundle model. 相似文献
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Sodium cromoglicate (SCG) has been available since around 1970 for the treatment of asthma and other allergic disorders in both adults and children. It has been approved for use around the world. Over the period of its development, a number of different formulations were introduced. In 1999, a systematic review of SCG use in childhood asthma was carried out and reported initially as a poster. Further systematic reviews and papers followed from the same authors and finally a Cochrane Collaboration review was published in 2003. All concluded that SCG was ineffective in paediatric asthma. Both the British Thoracic Society Guidelines for the treatment of paediatric asthma and the Model List of Essential Drugs of the WHO now reflect these conclusions. This paper looks carefully at the conclusions of these systematic reviews and raises concerns about the interpretation of the results. These failed to take adequate account of the changes with time in both the formulations used and the age groups examined, and also failed to take adequate note of the totality of information available over all end-points. One primary end-point was based on only four out of the 24 studies included in the review. Rather than having no effect, it is demonstrated that a considerable body of evidence favours SCG compared to placebo and, far from being ineffective, the drug appears to be effective particularly in older children. This article replaces a previously published version. DOI: 10.1002/pst.258. 相似文献
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Carroll KJ 《Pharmaceutical statistics》2006,5(4):283-293
In oncology, it may not always be possible to evaluate the efficacy of new medicines in placebo-controlled trials. Furthermore, while some newer, biologically targeted anti-cancer treatments may be expected to deliver therapeutic benefit in terms of better tolerability or improved symptom control, they may not always be expected to provide increased efficacy relative to existing therapies. This naturally leads to the use of active-control, non-inferiority trials to evaluate such treatments. In recent evaluations of anti-cancer treatments, the non-inferiority margin has often been defined in terms of demonstrating that at least 50% of the active control effect has been retained by the new drug using methods such as those described by Rothmann et al., Statistics in Medicine 2003; 22:239-264 and Wang and Hung Controlled Clinical Trials 2003; 24:147-155. However, this approach can lead to prohibitively large clinical trials and results in a tendency to dichotomize trial outcome as either 'success' or 'failure' and thus oversimplifies interpretation. With relatively modest modification, these methods can be used to define a stepwise approach to design and analysis. In the first design step, the trial is sized to show indirectly that the new drug would have beaten placebo; in the second analysis step, the probability that the new drug is superior to placebo is assessed and, if sufficiently high in the third and final step, the relative efficacy of the new drug to control is assessed on a continuum of effect retention via an 'effect retention likelihood plot'. This stepwise approach is likely to provide a more complete assessment of relative efficacy so that the value of new treatments can be better judged. 相似文献
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编辑推荐：与《货币战争》相比,《货币战争2：金权天下》更系统、更完善、更严密,更趋向于现实。以三百年的历史纵深,全面阐述欧美主要金融势力集团的历史沿革,系统解析当今世界幕后主宰力量的运作和决策机制,清晰地勾勒出了错综复杂的国际金融势力集团的人脉关系图谱,并预言：世界单一货币将在2024年成为现实。 相似文献
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In recent years, there has been a great deal of literature published concerning the identification of predictive biomarkers and indeed, an increasing number of therapies have been licenced on this basis. However, this progress has been made almost exclusively on the basis of biomarkers measured prior to exposure to treatment. There are quite different challenges when the responding population can only be identified on the basis of outcomes observed following exposure to treatment, especially if it represents only a small proportion of patients. The purpose of this paper is to explore whether or when a treatment could be licenced on the basis of post‐treatment predictive biomarkers (PTPB), the focus is on oncology but the concepts should apply to all therapeutic areas. We review the potential pitfalls in hypothesising the presence of a PTPB. We also present challenges in trial design required to confirm and licence on the basis of a PTPB: what's the control population?, could there be a detriment to non‐responders by exposure to the new treatment?, can responders be identified rapidly?, could prior exposure to the new treatment adversely affect performance of the control in responders? Nevertheless, if the patients to be treated could be rapidly identified after prior exposure to treatment, and without harm to non‐responders, in appropriately designed and analysed trials, may be more targeted therapies could be made available to patients. Copyright © 2014 John Wiley & Sons, Ltd. 相似文献