A statistical methodology for postmarketing surveillance of adverse drug reaction reports.

abstract：:This paper reviews several emerging and recurrent issues relating to the drug development process. These emerging issues include changes to the FDA regulatory environment, internationalization of drug development, advances in computer technology and visualization tools, and efforts to incorporate meta-analysis methodo...

journal_title：Statistics in medicine

authors： Anello C

更新日期：1999-09-15 00:00:00

abstract：:Many observational studies adopt what we call retrospective convenience sampling (RCS). With the sample size in each arm prespecified, RCS randomly selects subjects from the treatment-inclined subpopulation into the treatment arm and those from the control-inclined into the control arm. Samples in each arm are represe...

journal_title：Statistics in medicine

authors： Hu Z,Qin J

更新日期：2018-05-20 00:00:00

abstract：:Before introducing a new measurement tool it is necessary to evaluate its performance. Several statistical methods have been developed, or used, to evaluate the reliability and validity of a new assessment method in such circumstances. In this paper we review some commonly used methods. Data from a study that was cond...

journal_title：Statistics in medicine

authors： White SA,van den Broek NR

更新日期：2004-05-30 00:00:00

abstract：:In modern observational studies using electronic health records or other routinely collected data, both the outcome and covariates of interest can be error-prone and their errors often correlated. A cost-effective solution is the two-phase design, under which the error-prone outcome and covariates are observed for all...

journal_title：Statistics in medicine

authors： Tao R,Lotspeich SC,Amorim G,Shaw PA,Shepherd BE

更新日期：2021-02-10 00:00:00

abstract：:In many epidemiological studies it is common to resort to regression models relating incidence of a disease and its risk factors. The main goal of this paper is to consider inference on such models with error-prone observations and variances of the measurement errors changing across observations. We suppose that the o...

journal_title：Statistics in medicine

authors： de Castro M,Galea M,Bolfarine H

更新日期：2008-11-10 00:00:00

abstract：:Estimating the causal effect of quitting smoking on time to death or first myocardial infarction requires that one control for the differences in risk factors between individuals who elect to quite at each time t versus those who elect to continue smoking at time t. In this paper we examine the limitations of standard...

journal_title：Statistics in medicine

authors： Mark SD,Robins JM

更新日期：1993-09-15 00:00:00

abstract：:In biomedical studies and clinical trials, repeated measures are often subject to some upper and/or lower limits of detection. Hence, the responses are either left or right censored. A complication arises when more than one series of responses is repeatedly collected on each subject at irregular intervals over a perio...

journal_title：Statistics in medicine

authors： Lachos VH,A Matos L,Castro LM,Chen MH

更新日期：2019-03-15 00:00:00

abstract：:In the pharmaceutical industry, an assay method is considered validated if the accuracy and precision for an assay meet some acceptable limits. This paper discusses the assessment of assay precision in terms of the estimation of total variability of an assay from a one-way random effects model which is often considere...

journal_title：Statistics in medicine

authors： Chow SC,Tse SK

更新日期：1991-10-01 00:00:00

abstract：:Clinical trials often assess therapeutic benefit on the basis of an event such as death or the diagnosis of disease. Usually, there are several additional longitudinal measures of clinical status which are collected to be used in the treatment comparison. This paper proposes a simple non-parametric test which combines...

journal_title：Statistics in medicine

authors： Finkelstein DM,Schoenfeld DA

更新日期：1999-06-15 00:00:00

abstract：:Case-control studies are prone to low power for testing gene-environment interactions (GXE) given the need for a sufficient number of individuals on each strata of disease, gene, and environment. We propose a new study design to increase power by strategically pooling biospecimens. Pooling biospecimens allows us to in...

journal_title：Statistics in medicine

authors： Danaher MR,Schisterman EF,Roy A,Albert PS

更新日期：2012-11-20 00:00:00

abstract：:Log-linear models for capture-recapture type data are widely used for estimating sizes of populations. Log-linear methods model conditional interactions between the sources. Often, however, the marginal associations are more appropriate and easier for the practitioner to conceptualize. Analyses here of previously publ...

journal_title：Statistics in medicine

authors： Regal RR,Hook EB

更新日期：1998-01-15 00:00:00

abstract：:Recurrent event data are commonly encountered in health-related longitudinal studies. In this paper time-to-events models for recurrent event data are studied with non-informative and informative censorings. In statistical literature, the risk set methods have been confirmed to serve as an appropriate and efficient ap...

journal_title：Statistics in medicine

authors： Wang MC,Chiang CT

更新日期：2002-02-15 00:00:00

abstract：:We present an estimate of the kappa-coefficient of agreement between two methods of rating based on matched pairs of binary responses and show that the estimate depends on the common intraclass correlation coefficient between the pairs. Via Monte Carlo simulation, we investigate power of the test of significance on ka...

journal_title：Statistics in medicine

authors： Shoukri MM,Martin SW,Mian IU

更新日期：1995-01-15 00:00:00

abstract：:During phase III clinical trials in life-threatening disease settings, it is important to ensure that the Data Monitoring Committee (DMC) has exclusive access to the interim efficacy and safety data generated by the data analysis centre, in order to minimize the risk of widespread prejudgement of unreliable trial resu...

journal_title：Statistics in medicine

authors： Fleming TR,Ellenberg S,DeMets DL

更新日期：2002-10-15 00:00:00

abstract：:Estimation and group comparison of survival curves are two very common issues in survival analysis. In practice, the Kaplan-Meier estimates of survival functions may be biased due to unbalanced distribution of confounders. Here we develop an adjusted Kaplan-Meier estimator (AKME) to reduce confounding effects using in...

journal_title：Statistics in medicine

authors： Xie J,Liu C

更新日期：2005-10-30 00:00:00

abstract：:For robust detection performance, traditional control chart monitoring for biosurveillance is based on input data free of trends, day-of-week effects, and other systematic behaviour. Time series forecasting methods may be used to remove this behaviour by subtracting forecasts from observations to form residuals for al...

journal_title：Statistics in medicine

authors： Burkom HS,Murphy SP,Shmueli G

更新日期：2007-09-30 00:00:00

abstract：:Interpretation of the Mantoux test for tuberculous infection can be complicated by cross-reactions caused by infection with non-specific mycobacteria. Thus, the distribution of positive indurations is a mixture of two distributions. To estimate tuberculous infection prevalence, the marginal distribution of indurations...

journal_title：Statistics in medicine

authors： Nagelkerke NJ,Borgdorff MW,Kim SJ

更新日期：2001-04-15 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：:Kappa coefficients are measures of correlation between categorical variables often used as reliability or validity coefficients. We recapitulate development and definitions of the K (categories) by M (ratings) kappas (K x M), discuss what they are well- or ill-designed to do, and summarize where kappas now stand with ...

journal_title：Statistics in medicine

authors： Chmura Kraemer H,Periyakoil VS,Noda A

更新日期：2002-07-30 00:00:00

abstract：:A method for detecting deviations from the Loewe additive drug combination reference model for in vitro drug combination experimentation is described. It is often difficult to fit a response surface model to drug combination data, especially in situations where the experimental design contains a sparse set of combinat...

journal_title：Statistics in medicine

authors： Novick SJ

更新日期：2013-12-20 00:00:00

abstract：:Meta-analysis has generally been accepted as a fundamental tool for combining effect estimates from several studies. For binary studies with rare events, the Peto odds ratio (POR) method has become the relative effect estimator of choice. However, the POR leads to biased estimates for the OR when treatment effects are...

journal_title：Statistics in medicine

authors： Brockhaus AC,Bender R,Skipka G

更新日期：2014-12-10 00:00:00

abstract：:Existing methods for power analysis for longitudinal study designs are limited in that they do not adequately address random missing data patterns. Although the pattern of missing data can be assessed during data analysis, it is unknown during the design phase of a study. The random nature of the missing data pattern ...

journal_title：Statistics in medicine

authors： Tu XM,Zhang J,Kowalski J,Shults J,Feng C,Sun W,Tang W

更新日期：2007-07-10 00:00:00

abstract：:Prognostic models are used in medicine for investigating patient outcome in relation to patient and disease characteristics. Such models do not always work well in practice, so it is widely recommended that they need to be validated. The idea of validating a prognostic model is generally taken to mean establishing tha...

journal_title：Statistics in medicine

authors： Altman DG,Royston P

更新日期：2000-02-29 00:00:00

abstract：:The sojourn time, time spent in the preclinical detectable phase (PCDP) for chronic diseases, for example, breast cancer, plays an important role in the design and assessment of screening programmes. Traditional methods to estimate it usually assume a uniform incidence rate of preclinical disease from a randomized con...

journal_title：Statistics in medicine

authors： Duffy SW,Chen HH,Tabar L,Day NE

更新日期：1995-07-30 00:00:00

abstract：:We present some practical extensions and applications of a strategy proposed by Thall, Simon and Estey for designing and monitoring single-arm clinical trials with multiple outcomes. We show by application how the strategy may be applied to construct designs for phase IIA activity trials and phase II equivalence trial...

journal_title：Statistics in medicine

authors： Thall PF,Sung HG

更新日期：1998-07-30 00:00:00

abstract：:Case-control studies are usually defined to investigate risk factors for a single disease of interest. However, subsequent to data collection, investigators may wish to examine as an 'outcome' a variable that was an exposure in the original study. A naive analysis that disregards the sampling strategy that gave rise t...

journal_title：Statistics in medicine

authors： Reilly M,Torrång A,Klint A

更新日期：2005-12-30 00:00:00

abstract：:A popular method for analysing repeated-measures data is generalized estimating equations (GEE). When response data are missing at random (MAR), two modifications of GEE use inverse-probability weighting and imputation. The weighted GEE (WGEE) method involves weighting observations by their inverse probability of bein...

journal_title：Statistics in medicine

authors： Seaman S,Copas A

更新日期：2009-03-15 00:00:00

abstract：:Relative survival is used to estimate patient survival excluding causes of death not related to the disease of interest. Rather than using cause of death information from death certificates, which is often poorly recorded, relative survival compares the observed survival to that expected in a matched group from the ge...

journal_title：Statistics in medicine

authors： Lambert PC,Smith LK,Jones DR,Botha JL

更新日期：2005-12-30 00:00:00

abstract：:The coefficient of individual equivalence is a permutation-based measure of agreement between two observers making replicated readings on each subject. It compares the observed disagreement between the observers to the expected disagreement under individual equivalence. Individual equivalence of observers requires tha...

journal_title：Statistics in medicine

authors： Pan Y,Haber M,Gao J,Barnhart HX

更新日期：2012-09-10 00:00:00

abstract：:Sensible plans for health-care needs and determination of priorities for expenditure require regular assessment of trends in HIV incidences. In particular, trends in the relative HIV incidences of different risk categories are useful when assessing whether current control strategies are working equally well for all ri...

journal_title：Statistics in medicine

authors： Becker NG,Cui JS

更新日期：1996-08-30 00:00:00