Methods for proper handling of overrunning and underrunning in phase II designs for oncology trials.

abstract：:We have used Monte Carlo methods to compare the type I error properties of the conditional and unconditional versions of the generalized t and the generalized rank-sum tests to those of the independent samples t and Wilcoxon rank-sum tests. Results showed inflated type I errors for the conditional generalized tests bu...

journal_title：Statistics in medicine

authors： Blair RC,Morel JG

更新日期：1992-02-28 00:00:00

abstract：:In this paper, an approach to estimating the cumulative mean function for history process with time dependent covariates and right censored time-to-event variable is developed using the combined technique of joint modeling and inverse probability weighting method. The consistency of proposed estimator is derived. Theo...

journal_title：Statistics in medicine

authors： Deng D

更新日期：2016-11-10 00:00:00

abstract：:In the presence of confounding, the consistency assumption required for identification of causal effects may be violated due to misclassification of the outcome variable. We introduce an inverse probability weighted approach to rebalance covariates across treatment groups while mitigating the influence of differential...

journal_title：Statistics in medicine

authors： Gravel CA,Platt RW

更新日期：2018-02-10 00:00:00

abstract：:Several large-sample confidence intervals for the ratio of independent binomial proportions are compared in terms of exact coverage probability and width. A non-iterative approximate Bayesian interval is derived and its frequency properties are superior to all of the non-iterative confidence intervals considered. The ...

journal_title：Statistics in medicine

authors： Price RM,Bonett DG

更新日期：2008-11-20 00:00:00

abstract：:Many gene expression data are based on two experiments where the gene expressions of the targeted genes under both experiments are correlated. We consider problems in which objectives are to find genes that are simultaneously upregulated/downregulated under both experiments. A Bayesian methodology is proposed based on...

journal_title：Statistics in medicine

authors： Bansal NK,Jiang H,Pradeep P

更新日期：2015-11-10 00:00:00

abstract：:This paper presents tables analogous to T-tables for use in the 2 x 2 multinomial trial, where the continuity corrected Z-statistic is used to make exact unconditional inference. This is the first solution of a discrete exact unconditional inference problem involving a multivariate nuisance parameter for which no anci...

journal_title：Statistics in medicine

authors： Shuster JJ

更新日期：1992-05-01 00:00:00

abstract：:The risk that a drug newly introduced into medical use will occasionally cause adverse reactions is neither negligible nor totally avoidable. Only well organized systems of monitoring can bring early detection and appropriate action. These in turn require either detailed supervision or spontaneous reporting. The paper...

journal_title：Statistics in medicine

authors： Finney DJ

更新日期：1982-04-01 00:00:00

abstract：:In medical and health studies, heterogeneities in clustered count data have been traditionally modeled by positive random effects in Poisson mixed models; however, excessive zeros often occur in clustered medical and health count data. In this paper, we consider a three-level random effects zero-inflated Poisson model...

journal_title：Statistics in medicine

authors： Ma R,Hasan MT,Sneddon G

更新日期：2009-08-15 00:00:00

abstract：:The two-period cross-over design with two sequences of drug administration is a standard experimental design when bioequivalence of one test formulation is to be assessed in comparison with a reference formulation. Previously, an approach based on Fieller's confidence interval has been presented for the assessment of ...

journal_title：Statistics in medicine

authors： Vuorinen J

更新日期：1997-10-15 00:00:00

abstract：:Elevated plasma levels of apolipoproteins A1 (apoA1) and B (apoB) are important protective factors and risk factors, respectively, for atherosclerosis and coronary heart disease. It is well known that both apoA1 and apoB reveal strong familial aggregation. Our goal was to investigate whether exogenous variables influe...

journal_title：Statistics in medicine

authors： Ziegler A,Kastner C,Brunner D,Blettner M

更新日期：2000-12-30 00:00:00

abstract：:We propose to use a very simple model to test whether a cancer cluster is due to chance alone. We focus on the acute childhood leukaemia cluster in Columbus, Ohio. In 1975, 12 leukaemia cases were observed in Columbus while the expected number is 6 cases per year. According to our simple model, the probability of such...

journal_title：Statistics in medicine

authors： Schinazi RB

更新日期：2000-08-30 00:00:00

abstract：:We develop analysis methods for clinical trials with time-to-event outcomes which correct for treatment changes during follow-up, yet are based on comparisons of randomized groups and not of selected groups. A causal model relating observed event times to event times that would have been observed under other treatment...

journal_title：Statistics in medicine

authors： White IR,Babiker AG,Walker S,Darbyshire JH

更新日期：1999-10-15 00:00:00

abstract：:Predicting an individual's risk of experiencing a future clinical outcome is a statistical task with important consequences for both practicing clinicians and public health experts. Modern observational databases such as electronic health records provide an alternative to the longitudinal cohort studies traditionally ...

journal_title：Statistics in medicine

authors： Wolfson J,Bandyopadhyay S,Elidrisi M,Vazquez-Benitez G,Vock DM,Musgrove D,Adomavicius G,Johnson PE,O'Connor PJ

更新日期：2015-09-20 00:00:00

abstract：:We examine the properties of several tests for goodness-of-fit for multinomial logistic regression. One test is based on a strategy of sorting the observations according to the complement of the estimated probability for the reference outcome category and then grouping the subjects into g equal-sized groups. A g x c c...

journal_title：Statistics in medicine

authors： Fagerland MW,Hosmer DW,Bofin AM

更新日期：2008-09-20 00:00:00

abstract：:In drug-drug interaction (DDI) research, a two drug interaction is usually predicted by individual drug pharmacokinetics (PK). Although subject-specific drug concentration data from clinical PK studies on inhibitor/inducer or substrate's PK are not usually published, sample mean plasma drug concentrations and their st...

journal_title：Statistics in medicine

authors： Li L,Yu M,Chin R,Lucksiri A,Flockhart DA,Hall SD

更新日期：2007-09-10 00:00:00

abstract：:The objective of a phase II cancer clinical trial is to screen a treatment that can produce a similar or better response rate compared to the current treatment results. This screening is usually carried out in two stages as proposed by Simon. For ineffective treatment, the trial should terminate at the first stage. En...

journal_title：Statistics in medicine

authors： Chen TT

更新日期：1997-12-15 00:00:00

abstract：:We applied a two-stage random effects model to pulmonary function data from 31 sarcoidosis patients to illustrate its usefulness in analysing unbalanced longitudinal data. For the first stage, repeated measurements of percentage of predicted forced vital capacity (FVC%) from an individual were modelled as a function o...

journal_title：Statistics in medicine

authors： Vacek PM,Mickey RM,Bell DY

更新日期：1989-02-01 00:00:00

abstract：:We present a model for describing correlated binocular data from reader-based diagnostic studies, where the same group of readers evaluates the presence or absence of certain diseases on binocular organs (e.g., fellow eyes) of patients. Multiple random effects are incorporated to meaningfully delineate various associa...

journal_title：Statistics in medicine

authors： Withanage N,de Leon AR,Rudnisky CJ

更新日期：2015-12-20 00:00:00

abstract：:It is often assumed that randomisation will prevent bias in estimation of treatment effects from clinical trials, but this is not true of the semiparametric Proportional Hazards model for survival data when there is underlying risk heterogeneity. Here, a new formula is proposed for estimation of this bias, improving o...

journal_title：Statistics in medicine

authors： McNamee R

更新日期：2017-09-20 00:00:00

abstract：:We propose the use of Gaussian mixed models to analyse statistically 24 hour ambulatory blood pressure data from clinical trials. We develop specific models and apply them to data from a clinical study that compares two angiotensin-converting enzyme inhibitors. We investigate and discuss computing issues related to th...

journal_title：Statistics in medicine

authors： Selwyn MR,Difranco DM

更新日期：1993-09-30 00:00:00

abstract：:A model is developed to estimate the effect of covariate imbalance on the size of a test of treatment efficacy in randomized clinical trials comparing two treatments when dispersion parameters are known. It is concluded that tests of homogeneity on the covariates should not be performed, that covariate imbalance is ju...

journal_title：Statistics in medicine

authors： Senn SJ

更新日期：1989-04-01 00:00:00

abstract：:In longitudinal studies, missing observations occur commonly. It has been well known that biased results could be produced if missingness is not properly handled in the analysis. Authors have developed many methods with the focus on either incomplete response or missing covariate observations, but rarely on both. The ...

journal_title：Statistics in medicine

authors： Li H,Yi GY

更新日期：2013-02-28 00:00:00

abstract：:Although transportation safety has greatly improved over the past 2 decades, motor vehicle crash injuries remain a leading cause of morbidity and mortality, particularly among young drivers. Driver errors and behaviors such as speeding and distraction contribute disproportionately to crashes among inexperienced novice...

journal_title：Statistics in medicine

authors： Simons-Morton B

更新日期：2017-10-30 00:00:00

abstract：:Increasing numbers of economic evaluations are conducted alongside randomised controlled trials. Such studies include factorial trials, which randomise patients to different levels of two or more factors and can therefore evaluate the effect of multiple treatments alone and in combination. Factorial trials can provide...

journal_title：Statistics in medicine

authors： Dakin H,Gray A

更新日期：2017-08-15 00:00:00

abstract：:Methods for multiple informants help to estimate the marginal effect of each multiple source predictor and formally compare the strength of their association with an outcome. We extend multiple informant methods to the case of hierarchical data structures to account for within cluster correlation. We apply the propose...

journal_title：Statistics in medicine

authors： Baek J,Sánchez BN,Sanchez-Vaznaugh EV

更新日期：2014-02-20 00:00:00

abstract：:In many community-based studies on the incidence of dementia, a target population is screened and a subsample is clinically evaluated at baseline and follow-up. Incidence rates are affected by missed cases at both exams and this complicates the estimation of these rates. Recent work proposes a regression-based techniq...

journal_title：Statistics in medicine

authors： Izmirlian G,Brock D,White L

更新日期：2000-06-15 00:00:00

abstract：:Often in randomized clinical trials and observational studies in occupational and environmental health, a non-negative continuously distributed response variable denoting some metabolites of environmental toxicants is measured in treatment and control groups. When observations occur in both unexposed and exposed subje...

journal_title：Statistics in medicine

authors： Chu H,Nie L,Kensler TW

更新日期：2008-06-15 00:00:00

abstract：:A Non-Parametric Maximum Likelihood approach to the estimation of relative risks in the context of disease mapping is discussed and a NPML approximation to conditional autoregressive models is proposed. NPML estimates have been compared to other proposed solutions (Maximum Likelihood via Monte Carlo Scoring, Hierarchi...

journal_title：Statistics in medicine

authors： Biggeri A,Marchi M,Lagazio C,Martuzzi M,Böhning D

更新日期：2000-09-15 00:00:00

abstract：:For patients who were previously treated for prostate cancer, salvage hormone therapy is frequently given when the longitudinal marker prostate-specific antigen begins to rise during follow-up. Because the treatment is given by indication, estimating the effect of the hormone therapy is challenging. In a previous pape...

journal_title：Statistics in medicine

authors： Taylor JM,Shen J,Kennedy EH,Wang L,Schaubel DE

更新日期：2014-01-30 00:00:00

abstract：:The design of clinical trials often requires knowledge of quantities such as between- and within subject variances about which only imprecise information exists. To provide assurance that the study has the desired power to detect a minimum clinically meaningful difference between treatment groups. Gould, Gould and Shi...

journal_title：Statistics in medicine

authors： Shih WJ,Gould AL

更新日期：1995-10-30 00:00:00