An adapted F-test for homogeneity of variability in follow-on biological products.

abstract：:Diagnostic problems in medicine are sometimes polytomous, meaning that the outcome has more than two distinct categories. For example, ovarian tumors can be benign, borderline, primary invasive, or metastatic. Extending the main measure of binary discrimination, the c-statistic or area under the ROC curve, to nominal ...

journal_title：Statistics in medicine

authors： Van Calster B,Van Belle V,Vergouwe Y,Timmerman D,Van Huffel S,Steyerberg EW

更新日期：2012-10-15 00:00:00

abstract：:Delay in the outcome variable is challenging for outcome-adaptive randomization, as it creates a lag between the number of subjects accrued and the information known at the time of the analysis. Motivated by a real-life pediatric ulcerative colitis trial, we consider a case where a short-term predictor is available fo...

journal_title：Statistics in medicine

authors： Kim MO,Liu C,Hu F,Lee JJ

更新日期：2014-10-15 00:00:00

abstract：:During a course of human immunodeficiency virus (HIV-1) infection, the viral load usually increases sharply to a peak following infection and then drops rapidly to a steady state, where it remains until progression to AIDS. This steady state is often referred to as the viral set point. It is believed that the HIV vira...

journal_title：Statistics in medicine

authors： Mei Y,Wang L,Holte SE

更新日期：2008-01-15 00:00:00

abstract：:A general method is presented that allows the researcher to change statistical design elements such as the residual sample size during the course of an experiment, to include an interim analysis for early stopping when no formal rule for early stopping was foreseen, to increase or reduce the number of planned interim ...

journal_title：Statistics in medicine

authors： Müller HH,Schäfer H

更新日期：2004-08-30 00:00:00

abstract：:Toxicity probability interval designs have received increasing attention as a dose-finding method in recent years. In this study, we compared the two-stage, likelihood-based continual reassessment method (CRM), modified toxicity probability interval (mTPI), and the Bayesian optimal interval design (BOIN) in order to e...

journal_title：Statistics in medicine

authors： Horton BJ,Wages NA,Conaway MR

更新日期：2017-01-30 00:00:00

abstract：:The general linear mixed model provides a useful approach for analysing a wide variety of data structures which practising statisticians often encounter. Two such data structures which can be problematic to analyse are unbalanced repeated measures data and longitudinal data. Owing to recent advances in methods and sof...

journal_title：Statistics in medicine

authors： Cnaan A,Laird NM,Slasor P

更新日期：1997-10-30 00:00:00

abstract：:Providing personalized treatments designed to maximize benefits and minimizing harms is of tremendous current medical interest. One problem in this area is the evaluation of the interaction between the treatment and other predictor variables. Treatment effects in subgroups having the same direction but different magni...

journal_title：Statistics in medicine

authors： Chen W,Ghosh D,Raghunathan TE,Norkin M,Sargent DJ,Bepler G

更新日期：2012-12-10 00:00:00

abstract：:A common but not necessarily logical requirement in drug development is that a 'limit of quantitation' be set for chemical assays and that observations that fall below the limit should not be treated as real data but should be labelled as below the limit and set aside for special treatment. We examine five of seven ap...

journal_title：Statistics in medicine

authors： Senn S,Holford N,Hockey H

更新日期：2012-12-30 00:00:00

abstract：:To benefit Alzheimer's disease research, a central data co-ordinating centre (CDCC) is planned that will systematically collect data from 27 Alzheimer's disease centres (ADCs) located nationwide. This CDCC will combine, analyse and disseminate epidemiologic, demographic, clinical and neuropathological data to research...

journal_title：Statistics in medicine

authors： Cronin-Stubbs D,DeKosky ST,Morris JC,Evans DA

更新日期：2000-06-15 00:00:00

abstract：:This article deals with determination of a sample size that guarantees the success of a trial. We follow a Bayesian approach and we say an experiment is successful if it yields a large posterior probability that an unknown parameter of interest (an unknown treatment effect or an effects-difference) is greater than a c...

journal_title：Statistics in medicine

authors： Brutti P,De Santis F,Gubbiotti S

更新日期：2008-06-15 00:00:00

abstract：:Pearson's chi-squared, the likelihood-ratio, and Fisher-Freeman-Halton's test statistics are often used to test the association of unordered r x c tables. Asymptotical, exact conditional, or exact conditional with mid-p adjustment methods are commonly used to compute the p-value. We have compared test power and signif...

journal_title：Statistics in medicine

authors： Lydersen S,Pradhan V,Senchaudhuri P,Laake P

更新日期：2007-10-15 00:00:00

abstract：:In the recent years, studies of hepatitis B (HBV) and hepatitis C virus (HCV) dynamics have drawn great attention as they provide insight into the process of virus elimination/production and of infected cells decay during antiviral treatment. Estimates of viral dynamic parameters may be used to determine the lifetime ...

journal_title：Statistics in medicine

authors： Sypsa V,Hatzakis A

更新日期：2008-12-30 00:00:00

abstract：:The matched case-control designs are commonly used to control for potential confounding factors in genetic epidemiology studies especially epigenetic studies with DNA methylation. Compared with unmatched case-control studies with high-dimensional genomic or epigenetic data, there have been few variable selection metho...

journal_title：Statistics in medicine

authors： Sun H,Wang S

更新日期：2013-05-30 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：: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：:The 'landmark' and 'Simon and Makuch' non-parametric estimators of the survival function are commonly used to contrast the survival experience of time-dependent treatment groups in applications such as stem cell transplant versus chemotherapy in leukemia. However, the theoretical survival functions corresponding to th...

journal_title：Statistics in medicine

authors： Bernasconi DP,Rebora P,Iacobelli S,Valsecchi MG,Antolini L

更新日期：2016-03-30 00:00:00

abstract：:We provide a Bayesian analysis of data categorized into two levels of age (younger than 50 years, at least 50 years) and three levels of bone mineral density (normal, osteopenia, osteoporosis) for white females at least 20 years old in the third National Health and Nutrition Examination Survey. For the sample, the age...

journal_title：Statistics in medicine

authors： Nandram B,Liu N,Choi JW,Cox L

更新日期：2005-04-15 00:00:00

abstract：:In the analysis of survival data, there are often competing events that preclude an event of interest from occurring. Regression analysis with competing risks is typically undertaken using a cause-specific proportional hazards model. However, modern alternative methods exist for the analysis of the subdistribution haz...

journal_title：Statistics in medicine

authors： Lau B,Cole SR,Gange SJ

更新日期：2011-03-15 00:00:00

abstract：:In the comparison of two or more treatment groups to a control group, consider a study with non-decreasing repeated measurements of the same characteristic taken over a common set of time points for each subject. Based on the vector of possibly incomplete responses from each subject, this paper considers asymptoticall...

journal_title：Statistics in medicine

authors： Davis CS

更新日期：1996-12-15 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：: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：:A study of long term survival of 1487 patients given an allogeneic bone marrow transplant for acute myelogenous leukaemia and 729 patients given a transplant for severe aplastic anaemia was conducted by the International Bone Marrow Transplant Registry. One aim of this study is to determine if the mortality rates of t...

journal_title：Statistics in medicine

authors： Andersen PK,Horowitz MM,Klein JP,Socie G,Stone JV,Zhang MJ

更新日期：1999-06-30 00:00:00

abstract：:Bioequivalence assessment is an issue of great interest. Development of statistical methods for assessing bioequivalence is an important area of research for statisticians. Bioequivalence is usually determined based on the normal distribution. We relax this assumption and develop a semi-parametric mixed model for bioe...

journal_title：Statistics in medicine

authors： Ghosh P,Rosner GL

更新日期：2007-03-15 00:00:00

abstract：:The Box-Cox power exponential (BCPE) distribution, developed in this paper, provides a model for a dependent variable Y exhibiting both skewness and kurtosis (leptokurtosis or platykurtosis). The distribution is defined by a power transformation Y(nu) having a shifted and scaled (truncated) standard power exponential ...

journal_title：Statistics in medicine

authors： Rigby RA,Stasinopoulos DM

更新日期：2004-10-15 00:00:00

abstract：:Statistical methods for analyzing recurrent events have attracted significant attention. The majority of existing works consider situations in which subjects are observed over time periods and events of interest that occurred during the course of follow-up are recorded. In some applications, a subject may leave the st...

journal_title：Statistics in medicine

authors： Su PF,Zhong J,Ou HT

更新日期：2019-04-15 00:00:00

abstract：:In recent years, there has been an increasing trend in conducting seamless phase 2/3 clinical trials for drug development in the pharmaceutical industry due to the visible advantages compared with traditional approaches for separate phase 2 and 3 development. Innovative study designs have been proposed for seamless ph...

journal_title：Statistics in medicine

authors： Teng Z,Liang L,Liu G,Liu Y

更新日期：2018-12-10 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：:In this paper we examine the efficiency of a generalization of the traditional normal linear (LDA) or quadratic (QDA) discriminant analysis. This procedure (the generalized discriminant analysis, GDA) replaces each normal density used in the traditional classification rule by a Fourier series density estimator which '...

journal_title：Statistics in medicine

authors： Odom-Maryon T,Langholz B,Niland J,Azen S

更新日期：1991-03-01 00:00:00

abstract：:Most phase I dose-finding methods in oncology aim to find the maximum-tolerated dose from a set of prespecified doses. However, in practice, because of a lack of understanding of the true dose-toxicity relationship, it is likely that none of these prespecified doses are equal or reasonably close to the true maximum-to...

journal_title：Statistics in medicine

authors： Chu Y,Pan H,Yuan Y

更新日期：2016-09-10 00:00:00

abstract：:Novel therapies are challenging the standards of drug development. Agents with specific biologic targets, unknown dose-efficacy curves, and limited toxicity mandate novel designs to identify biologically optimal doses. We review two model-based designs that utilize either a proportional odds model or a continuation ra...

journal_title：Statistics in medicine

authors： Mandrekar SJ,Qin R,Sargent DJ

更新日期：2010-05-10 00:00:00