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31.
Marc Sobel 《统计学通讯:理论与方法》2018,47(24):5916-5933
Information before unblinding regarding the success of confirmatory clinical trials is highly uncertain. Current techniques using point estimates of auxiliary parameters for estimating expected blinded sample size: (i) fail to describe the range of likely sample sizes obtained after the anticipated data are observed, and (ii) fail to adjust to the changing patient population. Sequential MCMC-based algorithms are implemented for purposes of sample size adjustments. The uncertainty arising from clinical trials is characterized by filtering later auxiliary parameters through their earlier counterparts and employing posterior distributions to estimate sample size and power. The use of approximate expected power estimates to determine the required additional sample size are closely related to techniques employing Simple Adjustments or the EM algorithm. By contrast with these, our proposed methodology provides intervals for the expected sample size using the posterior distribution of auxiliary parameters. Future decisions about additional subjects are better informed due to our ability to account for subject response heterogeneity over time. We apply the proposed methodologies to a depression trial. Our proposed blinded procedures should be considered for most studies due to ease of implementation. 相似文献
32.
Prior information is often incorporated informally when planning a clinical trial. Here, we present an approach on how to incorporate prior information, such as data from historical clinical trials, into the nuisance parameter–based sample size re‐estimation in a design with an internal pilot study. We focus on trials with continuous endpoints in which the outcome variance is the nuisance parameter. For planning and analyzing the trial, frequentist methods are considered. Moreover, the external information on the variance is summarized by the Bayesian meta‐analytic‐predictive approach. To incorporate external information into the sample size re‐estimation, we propose to update the meta‐analytic‐predictive prior based on the results of the internal pilot study and to re‐estimate the sample size using an estimator from the posterior. By means of a simulation study, we compare the operating characteristics such as power and sample size distribution of the proposed procedure with the traditional sample size re‐estimation approach that uses the pooled variance estimator. The simulation study shows that, if no prior‐data conflict is present, incorporating external information into the sample size re‐estimation improves the operating characteristics compared to the traditional approach. In the case of a prior‐data conflict, that is, when the variance of the ongoing clinical trial is unequal to the prior location, the performance of the traditional sample size re‐estimation procedure is in general superior, even when the prior information is robustified. When considering to include prior information in sample size re‐estimation, the potential gains should be balanced against the risks. 相似文献
33.
本文介绍了岩石可钻性能全法在油田现场实脸研究的成果:确定其可钻性指标凡对地层的适用范围,证明K指标比其他可钻性指标能更容易、史好地反映出井下实际地层可钻性变化情无,用K指标预浏钻速与实际钻速接近. 相似文献
34.
In this article, we consider inference about the correlation coefficients of several bivariate normal distributions. We first propose computational approach tests for testing the equality of the correlation coefficients. In fact, these approaches are parametric bootstrap tests, and simulation studies show that they perform very satisfactory, and the actual sizes of these tests are better than other existing approaches. We also present a computational approach test and a parametric bootstrap confidence interval for inference about the parameter of common correlation coefficient. At the end, all the approaches are illustrated using two real examples. 相似文献
35.
A variable sample size (VSS) scheme directly monitoring the coefficient of variation (CV), instead of monitoring the transformed statistics, is proposed. Optimal chart parameters are computed based on two criteria: (i) minimizing the out-of-control ARL (ARL1) and (ii) minimizing the out-of-control ASS (ASS1). Then the performances are compared between these two criteria. The advantages of the proposed chart over the VSS chart based on the transformed statistics in the existing literature are: the former (i) provides an easier alternative as no transformation is involved and (ii) requires less number of observations to detect a shift when ASS1 is minimized. 相似文献
36.
Background
School shootings have approached epidemic levels in recent years. While mental illness is undoubtedly involved in nearly all cases of mass school violence, we sought to determine how environmental context may exacerbate preexisting personal factors. The present study investigated the associations between mass school shootings, school enrollment size, student–teacher ratios, and student transitions.Method
Our sample consisted of twenty-two mass school shooting cases between January 1995 and June 2014. Information about school shootings was gathered using preexisting school shooting databases and news media reports. Using state and national databases, data regarding school size and student–teacher ratios of incident schools were collected. Information about schools where shooters previously attended, as well as state average school statistics, were also obtained.Findings
Schools where mass shootings occurred had significantly higher enrollments than their state average counterparts. Additionally, students who committed a mass school shooting were significantly more likely to have previously attended a school with a smaller student body and/or a lower than state average student–teacher ratio.Conclusion
Our findings are consistent with previous literature indicating that smaller schools are less likely to experience acts of mass violence. Additionally, our results suggest that transitioning from a smaller, more supportive school to a larger, more anonymous school may exacerbate preexisting mental health issues among potential school shooters. The results of this study have significant implications for educational policy reform. 相似文献37.
A methodology is suggested for the estimation of the mass density and the cumulative ground deposition of a nonvolatile, nonneutrally buoyant, air pollutant (liquid or solid) released from a polluted column (following an explosion caused during routine operation in, e.g., the chemical industry or due to any kind of hostile act) and deposited on the ground via gravitational settling. In many cases, the deposited mass due to gravitational settling constitutes a significant fraction of the original inventory released from the source. Implementation of the methodology in preliminary risk assessments can serve as an efficient tool for emergency planning for both immediate and long‐term measures such as evacuation and decontamination. The methodology considers, inter alia, an estimation of the critical particle diameter, particle size, and mass distributions along the polluted column. This methodology was developed to apply in rural regions since proper application of relevant meteorological input data can be accomplished mainly for such areas. 相似文献
38.
Quadratic inference function (QIF) is an alternative methodology to the popular generalized estimating equations (GEE) approach, it does not involve direct estimation of the correlation parameter, and thus remains optimal even if the working correlation structure is misspecified. The idea is to represent the inverse of the working correlation matrix by a linear combination of some basis matrices. In this article, we present a modification of QIF with a robust variance estimator of the extended score function. Theoretical and numerical results show that the modified QIF attains better efficiency and achieves better small sample performance than the original QIF method. 相似文献
39.
In this paper, the two-parameter Pareto distribution is considered and the problem of prediction of order statistics from a future sample and that of its geometric mean are discussed. The Bayesian approach is applied to construct predictors based on observed k-record values for the cases when the future sample size is fixed and when it is random. Several Bayesian prediction intervals are derived. Finally, the results of a simulation study and a numerical example are presented for illustrating all the inferential procedures developed here. 相似文献
40.
Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation 下载免费PDF全文
Margaret Gamalo‐Siebers Jasmina Savic Cynthia Basu Xin Zhao Mathangi Gopalakrishnan Aijun Gao Guochen Song Simin Baygani Laura Thompson H. Amy Xia Karen Price Ram Tiwari Bradley P. Carlin 《Pharmaceutical statistics》2017,16(4):232-249
Children represent a large underserved population of “therapeutic orphans,” as an estimated 80% of children are treated off‐label. However, pediatric drug development often faces substantial challenges, including economic, logistical, technical, and ethical barriers, among others. Among many efforts trying to remove these barriers, increased recent attention has been paid to extrapolation; that is, the leveraging of available data from adults or older age groups to draw conclusions for the pediatric population. The Bayesian statistical paradigm is natural in this setting, as it permits the combining (or “borrowing”) of information across disparate sources, such as the adult and pediatric data. In this paper, authored by the pediatric subteam of the Drug Information Association Bayesian Scientific Working Group and Adaptive Design Working Group, we develop, illustrate, and provide suggestions on Bayesian statistical methods that could be used to design improved pediatric development programs that use all available information in the most efficient manner. A variety of relevant Bayesian approaches are described, several of which are illustrated through 2 case studies: extrapolating adult efficacy data to expand the labeling for Remicade to include pediatric ulcerative colitis and extrapolating adult exposure‐response information for antiepileptic drugs to pediatrics. 相似文献