Improved Transferability of Data‐Driven Damage Models Through Sample Selection Bias Correction

Damage models for natural hazards are used for decision making on reducing and transferring risk. The damage estimates from these models depend on many variables and their complex sometimes nonlinear relationships with the damage. In recent years, data‐driven modeling techniques have been used to capture those relationships. The available data to build such models are often limited. Therefore, in practice it is usually necessary to transfer models to a different context. In this article, we show that this implies the samples used to build the model are often not fully representative for the situation where they need to be applied on, which leads to a “sample selection bias.” In this article, we enhance data‐driven damage models by applying methods, not previously applied to damage modeling, to correct for this bias before the machine learning (ML) models are trained. We demonstrate this with case studies on flooding in Europe, and typhoon wind damage in the Philippines. Two sample selection bias correction methods from the ML literature are applied and one of these methods is also adjusted to our problem. These three methods are combined with stochastic generation of synthetic damage data. We demonstrate that for both case studies, the sample selection bias correction techniques reduce model errors, especially for the mean bias error this reduction can be larger than 30%. The novel combination with stochastic data generation seems to enhance these techniques. This shows that sample selection bias correction methods are beneficial for damage model transfer.     

从主权国家的兴衰看权力博弈形态的转型

传统的国际关系理论,无论是现实主义、自由主义、建构主义还是科学行为主义理论,都是把主权国家抽象成一个统一的国际关系行为体。这一行为主体有一致的利益,也自然要有一致的对外政策目标和手段。在20世纪,尤其是在两次世界大战和冷战期间,这一概念抽象是非常准确的。但冷战结束以后,尤其是进入21世纪以后,这一概念抽象逐渐与国际关系的现实相违背。一方面,国家综合实力并不能直接转化为具体领域的竞争优势;另一方面,很多国家,包括超级大国在内,其对外政策的主要阻力可能不是所谓的竞争对手,而是其国内不同的利益集团。这导致传统的国际关系理论,从假设到概念和推理层面,都已经无法解释和预测今天的世界,而权力小博弈理论可以为认识多元复杂互动博弈时代的国际关系提供一个新的解释框架。     

Interval estimation for conformance proportions of multiple quality characteristics

A conformance proportion is an important and useful index to assess industrial quality improvement. Statistical confidence limits for a conformance proportion are usually required not only to perform statistical significance tests, but also to provide useful information for determining practical significance. In this article, we propose approaches for constructing statistical confidence limits for a conformance proportion of multiple quality characteristics. Under the assumption that the variables of interest are distributed with a multivariate normal distribution, we develop an approach based on the concept of a fiducial generalized pivotal quantity (FGPQ). Without any distribution assumption on the variables, we apply some confidence interval construction methods for the conformance proportion by treating it as the probability of a success in a binomial distribution. The performance of the proposed methods is evaluated through detailed simulation studies. The results reveal that the simulated coverage probability (cp) for the FGPQ-based method is generally larger than the claimed value. On the other hand, one of the binomial distribution-based methods, that is, the standard method suggested in classical textbooks, appears to have smaller simulated cps than the nominal level. Two alternatives to the standard method are found to maintain their simulated cps sufficiently close to the claimed level, and hence their performances are judged to be satisfactory. In addition, three examples are given to illustrate the application of the proposed methods.     

Statistical testing strategies for assessing treatment efficacy and marker accuracy in phase III trials

When a candidate predictive marker is available, but evidence on its predictive ability is not sufficiently reliable, all‐comers trials with marker stratification are frequently conducted. We propose a framework for planning and evaluating prospective testing strategies in confirmatory, phase III marker‐stratified clinical trials based on a natural assumption on heterogeneity of treatment effects across marker‐defined subpopulations, where weak rather than strong control is permitted for multiple population tests. For phase III marker‐stratified trials, it is expected that treatment efficacy is established in a particular patient population, possibly in a marker‐defined subpopulation, and that the marker accuracy is assessed when the marker is used to restrict the indication or labelling of the treatment to a marker‐based subpopulation, ie, assessment of the clinical validity of the marker. In this paper, we develop statistical testing strategies based on criteria that are explicitly designated to the marker assessment, including those examining treatment effects in marker‐negative patients. As existing and developed statistical testing strategies can assert treatment efficacy for either the overall patient population or the marker‐positive subpopulation, we also develop criteria for evaluating the operating characteristics of the statistical testing strategies based on the probabilities of asserting treatment efficacy across marker subpopulations. Numerical evaluations to compare the statistical testing strategies based on the developed criteria are provided.     

Blinded continuous monitoring in clinical trials with recurrent event endpoints

In studies with recurrent event endpoints, misspecified assumptions of event rates or dispersion can lead to underpowered trials or overexposure of patients. Specification of overdispersion is often a particular problem as it is usually not reported in clinical trial publications. Changing event rates over the years have been described for some diseases, adding to the uncertainty in planning. To mitigate the risks of inadequate sample sizes, internal pilot study designs have been proposed with a preference for blinded sample size reestimation procedures, as they generally do not affect the type I error rate and maintain trial integrity. Blinded sample size reestimation procedures are available for trials with recurrent events as endpoints. However, the variance in the reestimated sample size can be considerable in particular with early sample size reviews. Motivated by a randomized controlled trial in paediatric multiple sclerosis, a rare neurological condition in children, we apply the concept of blinded continuous monitoring of information, which is known to reduce the variance in the resulting sample size. Assuming negative binomial distributions for the counts of recurrent relapses, we derive information criteria and propose blinded continuous monitoring procedures. The operating characteristics of these are assessed in Monte Carlo trial simulations demonstrating favourable properties with regard to type I error rate, power, and stopping time, ie, sample size.     

Inference and Decision Making for 21st-Century Drug Development and Approval

ABSTRACT

The cost and time of pharmaceutical drug development continue to grow at rates that many say are unsustainable. These trends have enormous impact on what treatments get to patients, when they get them and how they are used. The statistical framework for supporting decisions in regulated clinical development of new medicines has followed a traditional path of frequentist methodology. Trials using hypothesis tests of “no treatment effect” are done routinely, and the p-value < 0.05 is often the determinant of what constitutes a “successful” trial. Many drugs fail in clinical development, adding to the cost of new medicines, and some evidence points blame at the deficiencies of the frequentist paradigm. An unknown number effective medicines may have been abandoned because trials were declared “unsuccessful” due to a p-value exceeding 0.05. Recently, the Bayesian paradigm has shown utility in the clinical drug development process for its probability-based inference. We argue for a Bayesian approach that employs data from other trials as a “prior” for Phase 3 trials so that synthesized evidence across trials can be utilized to compute probability statements that are valuable for understanding the magnitude of treatment effect. Such a Bayesian paradigm provides a promising framework for improving statistical inference and regulatory decision making.     

On the estimation of non linear functions in stochastic volatility models

Abstract

This paper focuses on the inference of suitable generally non linear functions in stochastic volatility models. In this context, in order to estimate the variance of the proposed estimators, a moving block bootstrap (MBB) approach is suggested and discussed. Under mild assumptions, we show that the MBB procedure is weakly consistent. Moreover, a methodology to choose the optimal length block in the MBB is proposed. Some examples and simulations on the model are also made to show the performance of the proposed procedure.     

Modifications of sequential designs in bioequivalence trials

Bioequivalence (BE) studies are designed to show that two formulations of one drug are equivalent and they play an important role in drug development. When in a design stage, it is possible that there is a high degree of uncertainty on variability of the formulations and the actual performance of the test versus reference formulation. Therefore, an interim look may be desirable to stop the study if there is no chance of claiming BE at the end (futility), or claim BE if evidence is sufficient (efficacy), or adjust the sample size. Sequential design approaches specially for BE studies have been proposed previously in publications. We applied modification to the existing methods focusing on simplified multiplicity adjustment and futility stopping. We name our method modified sequential design for BE studies (MSDBE). Simulation results demonstrate comparable performance between MSDBE and the original published methods while MSDBE offers more transparency and better applicability. The R package MSDBE is available at https://sites.google.com/site/modsdbe/ . Copyright © 2015 John Wiley & Sons, Ltd.     

Confidence intervals,significance values,maximum likelihood estimates,etc. sharpened into Occam’s razors

Abstract

Confidence sets, p values, maximum likelihood estimates, and other results of non-Bayesian statistical methods may be adjusted to favor sampling distributions that are simple compared to others in the parametric family. The adjustments are derived from a prior likelihood function previously used to adjust posterior distributions.     

论数学教育中的数学观念体系

本文从培养数学观念的角度，就数学教育如何培养人们的科学思维方式和形成良好的思维习惯作一论述。