Sample Size Calculation and Blinded Sample Size Recalculation in Clinical Trials Where the Treatment Effect is Measured by the Relative Risk

In clinical trials with binary endpoints, the required sample size does not depend only on the specified type I error rate, the desired power and the treatment effect but also on the overall event rate which, however, is usually uncertain. The internal pilot study design has been proposed to overcome this difficulty. Here, nuisance parameters required for sample size calculation are re-estimated during the ongoing trial and the sample size is recalculated accordingly. We performed extensive simulation studies to investigate the characteristics of the internal pilot study design for two-group superiority trials where the treatment effect is captured by the relative risk. As the performance of the sample size recalculation procedure crucially depends on the accuracy of the applied sample size formula, we firstly explored the precision of three approximate sample size formulae proposed in the literature for this situation. It turned out that the unequal variance asymptotic normal formula outperforms the other two, especially in case of unbalanced sample size allocation. Using this formula for sample size recalculation in the internal pilot study design assures that the desired power is achieved even if the overall rate is mis-specified in the planning phase. The maximum inflation of the type I error rate observed for the internal pilot study design is small and lies below the maximum excess that occurred for the fixed sample size design.     

Graphical and Numerical Methods for Detecting Influential Observations in Complex Bingham Data

We describe methods to detect influential observations in a sample of pre-shapes when the underlying distribution is assumed to be complex Bingham. One of these methods is based on Cook's distance, which is derived from the likelihood of the complex Bingham distribution. Other method is related to the tangent space, which is based on the local influence for the multivariate normal distribution. A method to detect outliers is also explained. The application of the methods is illustrated in both a real dataset and a simulated sample.     

Mixture Models in View of Evidential Analysis

In some practical inferential situations, it is needed to mix some finite sort of distributions to fit an adequate model for multi-modal observations. In this article, using evidential analysis, we determine the sample size for supporting hypotheses about the mixture proportion and homogeneity. An Expectation-Maximization algorithm is used to evaluate the probability of strong misleading evidence based on modified likelihood ratio as a measure of support.     

Bayes Estimation Based on Joint Progressive Type II Censored Data Under LINEX Loss Function

In the lifetime experiments, the joint censoring scheme is useful for planning comparative purposes of two identical products manufactured coming from different lines. In this article, we will confine ourselves to the data obtained by conducting a joint progressive Type II censoring scheme on the basis of the two combined samples selected from the two lines. Moreover, it is supposed that the distributions of lifetimes of the two products satisfy in a proportional hazard model. A general form for the distributions is considered, and we tackle the problem of obtaining Bayes estimates under the squared error and linear-exponential (LINEX) loss functions. As a special case, the Weibull distribution is discussed in more detail. Finally, the estimated risks of the various estimators obtained are compared using the Monte Carlo method.     

Variable Selection in Joint Location and Scale Models of the Skew-t-Normal Distribution

Variable selection is an important issue in all regression analysis, and in this article, we investigate the simultaneous variable selection in joint location and scale models of the skew-t-normal distribution when the dataset under consideration involves heavy tail and asymmetric outcomes. We propose a unified penalized likelihood method which can simultaneously select significant variables in the location and scale models. Furthermore, the proposed variable selection method can simultaneously perform parameter estimation and variable selection in the location and scale models. With appropriate selection of the tuning parameters, we establish the consistency and the oracle property of the regularized estimators. These estimators are compared by simulation studies.     

Computation of the central and noncentral f distributions

Recursion relations suitable for rapid computation are derived for the cumulative distribution of F′ = (X/m)/(Y/n) where X is χ²(λ, m) and Y is independently χ²(n). When n is even no complicated function evaluations are needed. For n odd, a special doubly noncentral t distribution is needed to start the computation. Series representations for this t distribution are given with rigorous bounds on truncation errors. Proper recursion techniques for numerical evaluation of the special functions are given.     

A monte carlo investigation of a statistic for a bivariate missing data problem

Testing the equal means hypothesis of a bivariate normal distribution with homoscedastic varlates when the data are incomplete is considered. If the correlational parameter, ρ, is known, the well-known theory of the general linear model is easily employed to construct the likelihood ratio test for the two sided alternative. A statistic, T, for the case of ρ unknown is proposed by direct analogy to the likelihood ratio statistic when ρ is known. The null and nonnull distribution of T is investigated by Monte Carlo techniques. It is concluded that T may be compared to the conventional t distribution for testing the null hypothesis and that this procedure results in a substantial increase in power-efficiency over the procedure based on the paired t test which ignores the incomplete data. A Monte Carlo comparison to two statistics proposed by Lin and Stivers (1974) suggests that the test based on T is more conservative than either of their statistics.     

Tests of hypotheses based on ranks in the general linear model

A unified approach is developed for testing hypotheses in the general linear model based on the ranks of the residuals. It complements the nonparametric estimation procedures recently reported in the literature. The testing and estimation procedures together provide a robust alternative to least squares. The methods are similar in spirit to least squares so that results are simple to interpret. Hypotheses concerning a subset of specified parameters can be tested, while the remaining parameters are treated as nuisance parameters. Asymptotically, the test statistic is shown to have a chi-square distribution under the null hypothesis. This result is then extended to cover a sequence of contiguous alternatives from which the Pitman efficacy is derived. The general application of the test requires the consistent estimation of a functional of the underlying distribution and one such estimate is furnished.     

On a statistic useful in dimensionality reduction in multivariable linear stochastic system

In this paper we study the sampling properties of a test statistic which has important applications in the area of linear stochastic control systems with multi-inputs and multi-outputs. The statistic is the ratio of a partial sum of the eigenvalues of a sample covariance matrix and its trace. It turns out that using a method due to Sugiura we may derive a useful approximation for its distribution up to and including terms of order l/n, where n denotes the appropriate size. Numerical illustrations using real data are given.     

On a characterization of the dispersion matrix based on the properties of regression

This paper provides a partial solution to a problem posed by J. Neyman (1965) regarding the characterization of multivariate negative binomial distribution based on the properties of regression. It is shown that some of the properties of regression characterize the form of the nonsingular dispersion matrix of the parent distribution, which, interestingly enough, corresponds to only two types viz. those of positive and negative multivariate binomial distributions.