Model-based phase I designs incorporating toxicity and efficacy for single and dual agent drug combinations: methods and challenges.

abstract：:There has been substantial statistical literature in the last several decades on assessing agreement, and coverage probability approach was selected as a preferred index for assessing and improving measurement agreement in a core laboratory setting. With this approach, a satisfactory agreement is based on pre-specifie...

journal_title：Statistics in medicine

authors： Barnhart HX

更新日期：2016-08-15 00:00:00

abstract：:Recently, there has been much work on early phase cancer designs that incorporate both toxicity and efficacy data, called phase I-II designs because they combine elements of both phases. However, they do not explicitly address the phase II hypothesis test of H0 : p ≤ p0 , where p is the probability of efficacy at the ...

journal_title：Statistics in medicine

authors： Bartroff J,Lai TL,Narasimhan B

更新日期：2014-07-20 00:00:00

abstract：:In the pharmaceutical industry, some tests for quality assurance before, during and after the manufacture of a drug product involve a two-stage sampling technique. We propose statistical testing procedures in a two-stage sampling problem with large within-class sample sizes. We also derive a two-stage sampling plan by...

journal_title：Statistics in medicine

authors： Shao J,Chow SC

更新日期：1993-11-15 00:00:00

abstract：:Vaccination in populations can have several kinds of effects. Establishing that vaccination produces population-level effects beyond the direct effects in the vaccinated individuals can have important consequences for public health policy. Formal methods have been developed for study designs and analysis that can esti...

journal_title：Statistics in medicine

authors： Halloran ME,Hudgens MG

更新日期：2018-01-30 00:00:00

abstract：:To compare the survival functions based on right-truncated data, Lagakos et al. proposed a weighted logrank test based on a reverse time scale. This is in contrast to Bilker and Wang, who suggested a semi-parametric version of the Mann-Whitney test by assuming that the distribution of truncation times is known or can ...

journal_title：Statistics in medicine

authors： Chi Y,Tsai WY,Chiang CL

更新日期：2007-02-20 00:00:00

abstract：:Population dynamic models, commonly used tools in the study of epidemics and other complex population processes, are implicit non-linear mathematical equations. Inference based on such models can be difficult due to the problems associated with high dimensional parameters that may be non-identified and complex likelih...

journal_title：Statistics in medicine

authors： Brookhart MA,Hubbard AE,van der Laan MJ,Colford JM Jr,Eisenberg JN

更新日期：2002-12-15 00:00:00

abstract：:We consider methods for selecting the joint specification of the mean and variance functions in statistical models for rates or counts. Based on analyses of diagnosis-specific hospital discharge rates in Michigan, we show that a Poisson model with an extra variance component for the systematic variation is superior to...

journal_title：Statistics in medicine

authors： Wolfe RA,Petroni GR,McLaughlin CG,McMahon LF Jr

更新日期：1991-09-01 00:00:00

abstract：:We studied the problem of testing a hypothesized distribution in survival regression models when the data is right censored and survival times are influenced by covariates. A modified chi-squared type test, known as Nikulin-Rao-Robson statistic, is applied for the comparison of accelerated failure time models. This st...

journal_title：Statistics in medicine

authors： Tahir MR,Tran QX,Nikulin MS

更新日期：2017-05-30 00:00:00

abstract：:We study prevalence-dependent diagnostic accuracy measures, specifically, positive and negative predictive values. These measures permit an assessment of the clinical utility of diagnostic tests across populations with different disease prevalences. In many cases, prevalence may not be known with certainty and the eva...

journal_title：Statistics in medicine

authors： Li J,Fine JP,Safdar N

更新日期：2007-07-30 00:00:00

abstract：:Interim analyses are conducted to allow for early termination of the trial, for ethical as well as economical reasons. Here we consider interim analyses in repeated measurements studies where the measurements are binary. Two methods for analysing this kind of data are compared according to their operating characterist...

journal_title：Statistics in medicine

authors： Spiessens B,Lesaffre E,Verbeke G

更新日期：2003-02-28 00:00:00

abstract：:Genetic networks for gene expression data are often built by graphical models, which in turn are built from pair-wise correlations of gene expression levels. A key feature of building graphical models is the evaluation of conditional independence of two traits, given other traits. When conditional independence can be ...

journal_title：Statistics in medicine

authors： Yu Z,Wang L,Hildebrandt MA,Schaid DJ

更新日期：2008-08-30 00:00:00

abstract：:This paper discusses and compares several estimators of mean rate of change in unbalanced longitudinal data based on a model with randomly distributed regression coefficients across individuals. The estimators are unweighted and weighted means of these coefficients. The paper also evaluates commonly used variance esti...

journal_title：Statistics in medicine

authors： Palta M,Cook T

更新日期：1987-07-01 00:00:00

abstract：:Results from an analysis of traffic accidents from a study of the police records of four police stations in the Bangkok metropolis are presented. The main emphasis in this study was put on the development of a measure for traffic accident density. The traffic flow was estimated at the various study locations by traine...

journal_title：Statistics in medicine

authors： Ayuthya RS,Böhning D

更新日期：1995-11-15 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：:Technologic advances give rise to new tests for detecting disease in many fields, including cancer and sexually transmitted disease. Before a new disease screening test is approved for public use, its accuracy should be shown to be better than or at least not inferior to an existing test. Standards do not yet exist fo...

journal_title：Statistics in medicine

authors： Alonzo TA,Pepe MS,Moskowitz CS

更新日期：2002-03-30 00:00:00

abstract：:I derive the locally most powerful rank tests for acceleration against semi-parametric alternatives when some patients are cured of the disease. I consider some particular classes of alternatives and present simulation results to verify the validity of the proposed tests. Real data from clinical trials for childhood l...

journal_title：Statistics in medicine

authors： Lee JW

更新日期：1995-10-15 00:00:00

abstract：:This paper discusses design considerations and the role of randomization-based inference in randomized community intervention trials. We stress that longitudinal follow-up of cohorts within communities often yields useful information on the effects of intervention on individuals, whereas cross-sectional surveys can us...

journal_title：Statistics in medicine

authors： Gail MH,Mark SD,Carroll RJ,Green SB,Pee D

更新日期：1996-06-15 00:00:00

abstract：:In cancer clinical trials, patients often experience a recurrence of disease prior to the outcome of interest, overall survival. Additionally, for many cancers, there is a cured fraction of the population who will never experience a recurrence. There is often interest in how different covariates affect the probability...

journal_title：Statistics in medicine

authors： Conlon AS,Taylor JM,Sargent DJ

更新日期：2014-05-10 00:00:00

abstract：:Piecewise constant incidence models were developed to estimate the force of infection in women from age- and time-specific antenatal or neonatal seroprevalence data. Differential inclusion of infected women in sero-surveys compared to uninfected women was taken into account, with respect to both changes in inclusion r...

journal_title：Statistics in medicine

authors： Ades AE,Medley GF

更新日期：1994-09-30 00:00:00

abstract：:Correlated response data arise often in biomedical studies. The generalized estimation equation (GEE) approach is widely used in regression analysis for such data. However, there are few methods available to check the adequacy of regression models in GEE. In this paper, a graphical method is proposed based on Cook and...

journal_title：Statistics in medicine

authors： Pan W,Connett JE,Porzio GC,Weisberg S

更新日期：2001-10-15 00:00:00

abstract：:The Jimma Infant Survival Differential Longitudinal Study is an Ethiopian study, set up to establish risk factors affecting infant survival and to investigate socio-economic, maternal and infant-rearing factors that contribute most to the child's early survival. Here, a subgroup of about 1500 children born in Jimma to...

journal_title：Statistics in medicine

authors： Lesaffre E,Asefa M,Verbeke G

更新日期：1999-04-15 00:00:00

abstract：:Appropriate methods for meta-regression applied to a set of clinical trials, and the limitations and pitfalls in interpretation, are insufficiently recognized. Here we summarize recent research focusing on these issues, and consider three published examples of meta-regression in the light of this work. One principal m...

journal_title：Statistics in medicine

authors： Thompson SG,Higgins JP

更新日期：2002-06-15 00:00:00

abstract：:Bioequivalence or interaction trials are commonly studied in crossover design and can be analysed by nonlinear mixed effects models as an alternative to noncompartmental approach. We propose an extension of the population Fisher information matrix in nonlinear mixed effects models to design crossover pharmacokinetic t...

journal_title：Statistics in medicine

authors： Nguyen TT,Bazzoli C,Mentré F

更新日期：2012-05-20 00:00:00

abstract：:A frequent objective in medical research is the investigation of differences in patient survival between several experimental treatments and one standard treatment. In order to assess these differences statistically, we have to apply adjustments for multiple comparisons to prevent an increased number of false-positive...

journal_title：Statistics in medicine

authors： Herberich E,Hothorn T

更新日期：2012-01-13 00:00:00

abstract：:Standard randomization-based tests of sharp null hypotheses in randomized clinical trials, that is, intent-to-treat analyses, are valid without extraneous assumptions, but generally can be appropriately powerful only with alternative hypotheses that involve treatment assignment having an effect on outcome. In the cont...

journal_title：Statistics in medicine

authors： Rubin DB

更新日期：1998-02-15 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：:Assay sensitivity has been proposed as a criterion for including psychiatric clinical outcome studies in meta-analyses. The authors assess the performance of assay sensitivity as a method for determining study appropriateness for meta-analysis by calculating expected standard drug vs placebo effect sizes for various c...

journal_title：Statistics in medicine

authors： Gelfand LA,Strunk DR,Tu XM,Noble RE,Derubeis RJ

更新日期：2006-03-30 00:00:00

abstract：:This paper presents a mixture model which combines features of the usual Cox proportional hazards model with those of a class of models, known as mixtures-of-experts. The resulting model is more flexible than the usual Cox model in the sense that the log hazard ratio is allowed to vary non-linearly as a function of th...

journal_title：Statistics in medicine

authors： Rosen O,Tanner M

更新日期：1999-05-15 00:00:00

abstract：:Correct specification of the inverse probability weighting (IPW) model is necessary for consistent inference from a marginal structural Cox model (MSCM). In practical applications, researchers are typically unaware of the true specification of the weight model. Nonetheless, IPWs are commonly estimated using parametric...

journal_title：Statistics in medicine

authors： Karim ME,Platt RW,BeAMS study group.

更新日期：2017-06-15 00:00:00

abstract：:We have formulated the problem of determining whether there has been an upturn in HIV-1 seroconversion incidence over the first five years of follow-up in the Multicenter AIDS Cohort Study (MACS) as that of locating the minimum of a quadratic regression or examination of two-knot piecewise spline models. Under a quadr...

journal_title：Statistics in medicine

authors： Zhou SY,Kingsley LA,Taylor JM,Chmiel JS,He DY,Hoover DR

更新日期：1993-01-30 00:00:00