Interpretation of results from subset analyses within overviews of randomized clinical trials.

abstract：:This paper describes compliance with the completion of a quality of life questionnaire in the Breast Cancer Prevention Trial, a large multi-centre randomized trial that is studying the efficacy of Tamoxifen in preventing breast cancer. In the first 4875 women enrolled in the control arm of the study, there was a very ...

journal_title：Statistics in medicine

authors： Ganz PA,Day R,Costantino J

更新日期：1998-03-15 00:00:00

abstract：:New combination regimens evaluated in phase II cancer clinical trials often show promising results compared to the standard therapy for a disease system. Selection of patients with a better prognosis can be a prominent factor for this optimism. For most disease systems, prognostic variables that are related to the out...

journal_title：Statistics in medicine

authors： Mazumdar M,Fazzari M,Panageas KS

更新日期：2001-03-30 00:00:00

abstract：:For clinical trials with multiple treatment arms or endpoints a variety of sequentially rejective, weighted Bonferroni-type tests have been proposed, such as gatekeeping procedures, fixed sequence tests, and fallback procedures. They allow to map the difference in importance as well as the relationship between the var...

journal_title：Statistics in medicine

authors： Bretz F,Maurer W,Brannath W,Posch M

更新日期：2009-02-15 00:00:00

abstract：:It has been well known that ignoring measurement error may result in substantially biased estimates in many contexts including linear and nonlinear regressions. For survival data with measurement error in covariates there has been extensive discussion in the literature with the focus being on the Cox proportional haza...

journal_title：Statistics in medicine

authors： He W,Yi GY,Xiong J

更新日期：2007-11-20 00:00:00

abstract：:Flexible survival models are in need when modelling data from long term follow-up studies. In many cases, the assumption of proportionality imposed by a Cox model will not be valid. Instead, a model that can identify time varying effects of fixed covariates can be used. Although there are several approaches that deal ...

journal_title：Statistics in medicine

authors： Perperoglou A

更新日期：2016-12-10 00:00:00

abstract：:The FDA permits marketing of a generic formulation of a drug G for the same indications as a standard preparation S if one can show that G is bioequivalent to S. Present implementation requires convincing evidence that the population mean difference in bioavailability (drug exposure) between the two preparations lies ...

journal_title：Statistics in medicine

authors： Sheiner LB

更新日期：1992-09-30 00:00:00

abstract：:In many chronic disease processes subjects are at risk of two or more types of events. We describe a bivariate mixed Poisson model in which a copula function is used to model the association between two gamma distributed random effects. The resulting model is a bivariate negative binomial process in which each type of...

journal_title：Statistics in medicine

authors： Cook RJ,Lawless JF,Lee KA

更新日期：2010-03-15 00:00:00

abstract：:Few methods are currently available for group sequential analysis of recurrent events data subject to a terminal event in the clinical trial setting. This research helps fill this gap by developing a completely nonparametric group sequential monitoring procedure for use with the two-sample Tayob and Murray statistic. ...

journal_title：Statistics in medicine

authors： Xia M,Murray S,Tayob N

更新日期：2019-12-30 00:00:00

abstract：:A new, intuitive method has recently been proposed to explore treatment-covariate interactions in survival data arising from two treatment arms of a clinical trial. The method is based on constructing overlapping subpopulations of patients with respect to one (or more) covariates of interest and in observing the patte...

journal_title：Statistics in medicine

authors： Bonetti M,Zahrieh D,Cole BF,Gelber RD

更新日期：2009-04-15 00:00:00

abstract：:Variation in heart disease (HD) mortality rates across census tracts is greater than expected given binomial error and available explanatory variables. We extended an extra-binomial variation model for rates standardized by the direct method. The overdispersion parameter accounted for 36 per cent of the observed varia...

journal_title：Statistics in medicine

authors： Jarjoura D,Logue E

更新日期：1990-10-01 00:00:00

abstract：:Statistical inference based on correlated count measurements are frequently performed in biomedical studies. Most of existing sample size calculation methods for count outcomes are developed under the Poisson model. Deviation from the Poisson assumption (equality of mean and variance) has been widely documented in pra...

journal_title：Statistics in medicine

authors： Li D,Zhang S,Cao J

更新日期：2019-12-10 00:00:00

abstract：:Missing data arise in crossover trials, as they do in any form of clinical trial. Several papers have addressed the problems that missing data create, although almost all of these assume that the probability that a planned observation is missing does not depend on the value that would have been observed; that is, the ...

journal_title：Statistics in medicine

authors： Ho WK,Matthews JN,Henderson R,Farewell D,Rodgers LR

更新日期：2012-07-20 00:00:00

abstract：:We examine Goodman and Kruskal's lambda using Efron's approach to regression and analysis of variance (ANOVA) for zero-one outcome data. For a binary response cross-classified by a single nominal predictor, we present a computationally simple ANOVA table in which lambda is analogous to Pearson's R-square. We character...

journal_title：Statistics in medicine

authors： Makuch RW,Rosenberg PS,Scott G

更新日期：1989-05-01 00:00:00

abstract：:Members of a cohort of workers in chemical industry (the so-called Boehringer cohort) exposed to 2, 3, 7, 8-tetrachlorodibenzo-para-dioxin (TCDD) from 1950 to 1984 were subject in the years 1985-1986 and 1992-1994 to an extensive biomonitoring programme on the TCDD levels of the individual workers. For establishing a ...

journal_title：Statistics in medicine

authors： Heinzl H,Mittlböck M,Edler L

更新日期：2008-05-30 00:00:00

abstract：:Although radical changes in drug regulation are rare (e.g., the Federal Food, Drug and Cosmetic Act of 1938 and the 1962 amendment to the Act creating an effectiveness requirement), regulations and guidance do evolve significantly in the face of new problems and accumulating experience. Recent changes have been driven...

journal_title：Statistics in medicine

authors： Temple R

更新日期：2002-10-15 00:00:00

abstract：:Clinical trials, especially the randomized clinical trial, have been and will remain the gold standard for the evaluation of new interventions, including pharmaceuticals, biologics, medical devices, procedures, or behavioral modifications. Despite more than five decades of experience, there are still challenges in the...

journal_title：Statistics in medicine

authors： DeMets DL

更新日期：2012-11-10 00:00:00

abstract：:Although there are many models which are used to calculate the health benefits (and thus the cost-effectiveness) of vaccination programmes, they can be divided into two groups: those which assume a constant force of infection, that is a constant per-susceptible rate of infection; and those which assume that the force ...

journal_title：Statistics in medicine

authors： Edmunds WJ,Medley GF,Nokes DJ

更新日期：1999-12-15 00:00:00

abstract：:The weighted average treatment effect is a causal measure for the comparison of interventions in a specific target population, which may be different from the population where data are sampled from. For instance, when the goal is to introduce a new treatment to a target population, the question is what efficacy (or ef...

journal_title：Statistics in medicine

authors： Tao Y,Fu H

更新日期：2019-02-10 00:00:00

abstract：:We simulated multinomial AIDS incidence counts from 27 'representative' AIDS epidemics that spanned a period corresponding to previous applications of backcalculation (1 January 1977 to 1 July 1987) and assessed mean square error for several back-calculated estimators of HIV prevalence and short-term AIDS projections....

journal_title：Statistics in medicine

authors： Rosenberg PS,Gail MH,Pee D

更新日期：1991-08-01 00:00:00

abstract：:In clinical research, we are often interested in assessing how a biomarker changes with time, and whether it could be used as a surrogate marker when evaluating the efficacy of a new drug. However, when the longitudinal marker is correlated with survival, linear mixed models for longitudinal data may be inappropriate....

journal_title：Statistics in medicine

authors： Deslandes E,Chevret S

更新日期：2007-12-30 00:00:00

abstract：:The analysis of repeated measures data can be conducted efficiently using a two-level random coefficients model. A standard assumption is that the within-individual (level 1) residuals are uncorrelated. In some cases, especially where measurements are made close together in time, this may not be reasonable and this ad...

journal_title：Statistics in medicine

authors： Goldstein H,Healy MJ,Rasbash J

更新日期：1994-08-30 00:00:00

abstract：:The objective of this report is to provide a basis to inform decisions about priorities for developing statistical research initiatives in the field of public health surveillance for emerging threats. Rapid information system advances have created a vast opportunity of secondary data sources for information to enhance...

journal_title：Statistics in medicine

authors： Rolka H,Burkom H,Cooper GF,Kulldorff M,Madigan D,Wong WK

更新日期：2007-04-15 00:00:00

abstract：:Multi-state models are useful for modelling disease progression where the state space of the process is used to represent the discrete disease status of subjects. Often, the disease process is only observed at clinical visits, and the schedule of these visits can depend on the disease status of patients. In such situa...

journal_title：Statistics in medicine

authors： Lesperance ML,Sabelnykova V,Nathoo FS,Lau F,Downing MG

更新日期：2015-12-20 00:00:00

abstract：:Identification of the latency period for the effect of a time-varying exposure is key when assessing many environmental, nutritional, and behavioral risk factors. A pre-specified exposure metric involving an unknown latency parameter is often used in the statistical model for the exposure-disease relationship. Likelih...

journal_title：Statistics in medicine

authors： Peskoe SB,Spiegelman D,Wang M

更新日期：2019-03-30 00:00:00

abstract：:The power prior has been widely used in many applications covering a large number of disciplines. The power prior is intended to be an informative prior constructed from historical data. It has been used in clinical trials, genetics, health care, psychology, environmental health, engineering, economics, and business. ...

journal_title：Statistics in medicine

authors： Ibrahim JG,Chen MH,Gwon Y,Chen F

更新日期：2015-12-10 00:00:00

abstract：:Comparison of two hazard rate functions is important for evaluating treatment effect in studies concerning times to some important events. In practice, it may happen that the two hazard rate functions cross each other at one or more unknown time points, representing temporal changes of the treatment effect. Also, besi...

journal_title：Statistics in medicine

authors： Park KY,Qiu P

更新日期：2014-11-20 00:00:00

abstract：:Identification of treatment selection biomarkers has become very important in cancer drug development. Adaptive enrichment designs have been developed for situations where a unique treatment selection biomarker is not apparent based on the mechanism of action of the drug. With such designs, the eligibility rules may b...

journal_title：Statistics in medicine

authors： Simon R,Simon N

更新日期：2017-11-20 00:00:00

abstract：:Meta analysis is a collection of quantitative methods devoted to combine summary information from related but independent studies. Because research reports usually present only data reductions and summary statistics rather than detailed data, the reviewer must often resort to rather crude methods for constructing summ...

journal_title：Statistics in medicine

authors： Di Pietrantonj C

更新日期：2006-07-15 00:00:00

abstract：:The introduction of potent antiretroviral therapies for treatment of HIV infection typically results in a dramatic reduction in plasma HIV RNA concentration, often to levels undetectable by current measurement practices. However, although a high proportion of patients achieve 'undetectability', many then experience a ...

journal_title：Statistics in medicine

authors： McKinnon EJ,James IR,John M,Mallal SA

更新日期：2003-02-15 00:00:00

abstract：:Ewell and Ibrahim derived the large sample distribution of the logrank statistic under general local alternatives. Their asymptotic results enable us to extend several group sequential designs which allow for early stopping in favour of the null hypothesis to the setting in which the cure rate model is appropriate. In...

journal_title：Statistics in medicine

authors： Patricia Bernardo MV,Ibrahim JG

更新日期：2000-11-30 00:00:00