Conflicts of interest in data monitoring of industry versus publicly financed clinical trials.

Abstract:

:The FDA Guidance, while highly appropriate for industry sponsored trials, need not be imposed on publicly (e.g. NIH) financed clinical trials. While the potential for conflicts of interest exist in the latter, they are in general manageable and pose an acceptable low risk of threatening the integrity of a study. However, the Guidance should heighten the awareness of all investigators in public trials to the potential for the appearance of conflicts and to the need for full and open participation in the management of dualities of interest.

journal_name

Stat Med

journal_title

Statistics in medicine

authors

Lachin JM

doi

10.1002/sim.1787

subject

Has Abstract

pub_date

2004-05-30 00:00:00

pages

1519-21

issue

10

eissn

0277-6715

issn

1097-0258

journal_volume

23

pub_type

杂志文章
  • Survival analysis for recurrent event data: an application to childhood infectious diseases.

    abstract::Many extensions of survival models based on the Cox proportional hazards approach have been proposed to handle clustered or multiple event data. Of particular note are five Cox-based models for recurrent event data: Andersen and Gill (AG); Wei, Lin and Weissfeld (WLW); Prentice, Williams and Peterson, total time (PWP-...

    journal_title:Statistics in medicine

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1002/(sici)1097-0258(20000115)19:1<13::aid-sim2

    authors: Kelly PJ,Lim LL

    更新日期:2000-01-15 00:00:00

  • Drug treatment of mild hypertension to reduce the risk of CHD: is it worth-while?

    abstract::Although hypertension is regarded as a causal factor for coronary heart disease (CHD) a reduction in the risk of CHD as a result of lowering blood pressure in mild hypertension could not be demonstrated. This conclusion is based on an overview analysis of all published randomized trials in mild hypertension, including...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4780071104

    authors: Holme I

    更新日期:1988-11-01 00:00:00

  • Causal inference in survival analysis using pseudo-observations.

    abstract::Causal inference for non-censored response variables, such as binary or quantitative outcomes, is often based on either (1) direct standardization ('G-formula') or (2) inverse probability of treatment assignment weights ('propensity score'). To do causal inference in survival analysis, one needs to address right-censo...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.7297

    authors: Andersen PK,Syriopoulou E,Parner ET

    更新日期:2017-07-30 00:00:00

  • Interval estimation for rank correlation coefficients based on the probit transformation with extension to measurement error correction of correlated ranked data.

    abstract::The Spearman (rho(s)) and Kendall (tau) rank correlation coefficient are routinely used as measures of association between non-normally distributed random variables. However, confidence limits for rho(s) are only available under the assumption of bivariate normality and for tau under the assumption of asymptotic norma...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.2547

    authors: Rosner B,Glynn RJ

    更新日期:2007-02-10 00:00:00

  • An improved algorithm for outbreak detection in multiple surveillance systems.

    abstract::In England and Wales, a large-scale multiple statistical surveillance system for infectious disease outbreaks has been in operation for nearly two decades. This system uses a robust quasi-Poisson regression algorithm to identify abberrances in weekly counts of isolates reported to the Health Protection Agency. In this...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.5595

    authors: Noufaily A,Enki DG,Farrington P,Garthwaite P,Andrews N,Charlett A

    更新日期:2013-03-30 00:00:00

  • Assessment of equivalence on multiple endpoints.

    abstract::Some clinical trials aim to demonstrate therapeutic equivalence on multiple primary endpoints. For example, therapeutic equivalence studies of agents for the treatment of osteoarthritis use several primary endpoints including investigator's global assessment of disease activity, patient's global assessment of response...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.985

    authors: Quan H,Bolognese J,Yuan W

    更新日期:2001-11-15 00:00:00

  • Analyzing sequentially randomized trials based on causal effect models for realistic individualized treatment rules.

    abstract::In this paper, we argue that causal effect models for realistic individualized treatment rules represent an attractive tool for analyzing sequentially randomized trials. Unlike a number of methods proposed previously, this approach does not rely on the assumption that intermediate outcomes are discrete or that models ...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.3268

    authors: Bembom O,van der Laan MJ

    更新日期:2008-08-30 00:00:00

  • Intentionally incomplete longitudinal designs: I. Methodology and comparison of some full span designs.

    abstract::Longitudinal designs are important in medical research and in many other disciplines. Complete longitudinal studies, in which each subject is evaluated at each measurement occasion, are often very expensive and motivate a search for more efficient designs. Recently developed statistical methods foster the use of inten...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4780111411

    authors: Helms RW

    更新日期:1992-10-01 00:00:00

  • Promoting interactions with basic scientists and clinicians: the NIA Alzheimer's Disease Data Coordinating Center.

    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

    pub_type: 杂志文章

    doi:10.1002/(sici)1097-0258(20000615/30)19:11/12<1453:

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

    更新日期:2000-06-15 00:00:00

  • Estimation of dynamic treatment strategies for maintenance therapy of children with acute lymphoblastic leukaemia: an application of history-adjusted marginal structural models.

    abstract::Childhood acute lymphoblastic leukaemia is treated with long-term intensive chemotherapy. During the latter part of the treatment, the maintenance therapy, the patients receive oral doses of two cytostatics. The doses are tailored to blood counts measured on a weekly basis, and the treatment is therefore highly dynami...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4393

    authors: Rosthøj S,Keiding N,Schmiegelow K

    更新日期:2012-02-28 00:00:00

  • Multilevel mixed effects parametric survival models using adaptive Gauss-Hermite quadrature with application to recurrent events and individual participant data meta-analysis.

    abstract::Multilevel mixed effects survival models are used in the analysis of clustered survival data, such as repeated events, multicenter clinical trials, and individual participant data (IPD) meta-analyses, to investigate heterogeneity in baseline risk and covariate effects. In this paper, we extend parametric frailty model...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.6191

    authors: Crowther MJ,Look MP,Riley RD

    更新日期:2014-09-28 00:00:00

  • True verification probabilities should not be used in estimating the area under receiver operating characteristic curve.

    abstract::In medical research, a two-phase study is often used for the estimation of the area under the receiver operating characteristic curve (AUC) of a diagnostic test. However, such a design introduces verification bias. One of the methods to correct verification bias is inverse probability weighting (IPW). Since the probab...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.8700

    authors: Wu Y

    更新日期:2020-11-30 00:00:00

  • Detection rates and false positive rates for Down's syndrome screening: how precisely can they be estimated and what factors influence their value?

    abstract::Down's syndrome screening is currently carried out using a combination of biochemical markers measured in maternal serum samples; these include MSAFP, Total hCG, uE3 and Free beta-hCG. Recently a number of papers have compared the effectiveness of different combinations of these markers. Some recommend MSAFP, Total hC...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/(sici)1097-0258(19970715)16:13<1481::aid-s

    authors: Dunstan FD,Gray JC,Nix AB,Reynolds T

    更新日期:1997-07-15 00:00:00

  • Mean square error of estimates of HIV prevalence and short-term AIDS projections derived by backcalculation.

    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

    pub_type: 杂志文章

    doi:10.1002/sim.4780100802

    authors: Rosenberg PS,Gail MH,Pee D

    更新日期:1991-08-01 00:00:00

  • The application of large Gaussian mixed models to the analysis of 24 hour ambulatory blood pressure monitoring data in clinical trials.

    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

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1002/sim.4780121803

    authors: Selwyn MR,Difranco DM

    更新日期:1993-09-30 00:00:00

  • A small sample study of the STEPP approach to assessing treatment-covariate interactions in survival data.

    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

    pub_type: 杂志文章

    doi:10.1002/sim.3524

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

    更新日期:2009-04-15 00:00:00

  • Methods for analyzing data from probabilistic linkage strategies based on partially identifying variables.

    abstract::In record linkage studies, unique identifiers are often not available, and therefore, the linkage procedure depends on combinations of partially identifying variables with low discriminating power. As a consequence, wrongly linked covariate and outcome pairs will be created and bias further analysis of the linked data...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.5498

    authors: Hof MH,Zwinderman AH

    更新日期:2012-12-30 00:00:00

  • Precision of incidence predictions based on Poisson distributed observations.

    abstract::Disease incidence predictions are useful for a number of administrative and scientific purposes. The simplest ones are made using trend extrapolation, on either an arithmetic or a logarithmic scale. This paper shows how approximate confidence prediction intervals can be calculated for such predictions, both for the to...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4780131503

    authors: Hakulinen T,Dyba T

    更新日期:1994-08-15 00:00:00

  • Longitudinal quantile regression in the presence of informative dropout through longitudinal-survival joint modeling.

    abstract::We propose a joint model for a time-to-event outcome and a quantile of a continuous response repeatedly measured over time. The quantile and survival processes are associated via shared latent and manifest variables. Our joint model provides a flexible approach to handle informative dropout in quantile regression. A M...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.6393

    authors: Farcomeni A,Viviani S

    更新日期:2015-03-30 00:00:00

  • Statistical issues related to dietary intake as the response variable in intervention trials.

    abstract::The focus of this paper is dietary intervention trials. We explore the statistical issues involved when the response variable, intake of a food or nutrient, is based on self-report data that are subject to inherent measurement error. There has been little work on handling error in this context. A particular feature of...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.7011

    authors: Keogh RH,Carroll RJ,Tooze JA,Kirkpatrick SI,Freedman LS

    更新日期:2016-11-10 00:00:00

  • Redesign of trials under different enrollment mixes.

    abstract::A few large multi-centre male-only heart trials done in the 1970s and 1980s have been seen as ill-conceived because they did not include females. The purpose here is to revisit two of those trials and to consider consequences in terms of cost and power had they been designed to include females. ...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/(sici)1097-0258(19990215)18:3<241::aid-sim

    authors: Meinert CL

    更新日期:1999-02-15 00:00:00

  • How should meta-regression analyses be undertaken and interpreted?

    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

    pub_type: 杂志文章

    doi:10.1002/sim.1187

    authors: Thompson SG,Higgins JP

    更新日期:2002-06-15 00:00:00

  • Adjustments to the Mantel-Haenszel chi-square statistic and odds ratio variance estimator when the data are clustered.

    abstract::Dependence between observations on a dichotomous variable renders invalid the usual chi-square tests of independence and inflates the variances of parameter estimates. Such a situation occurs, for example, when subjects consist of members of the same family or with repeated observations on the same person. In this pap...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4780060408

    authors: Donald A,Donner A

    更新日期:1987-06-01 00:00:00

  • Surveillance of clustering near point sources.

    abstract::Health authorities are often alerted to suspected cancer clusters near the vicinity of potential point sources by members of the public. A surveillance system, where administrative regions around the potential point sources are regularly monitored for high disease rates, would allow for responses which are easier to o...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/(sici)1097-0258(19960415)15:7/9<727::aid-s

    authors: Le ND,Petkau AJ,Rosychuk R

    更新日期:1996-04-15 00:00:00

  • SARS incubation and quarantine times: when is an exposed individual known to be disease free?

    abstract::The setting of a quarantine time for an emerging infectious disease will depend on current knowledge concerning incubation times. Methods for the analysis of information on incubation times are investigated with a particular focus on inference regarding a possible maximum incubation time, after which an exposed indivi...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.2206

    authors: Farewell VT,Herzberg AM,James KW,Ho LM,Leung GM

    更新日期:2005-11-30 00:00:00

  • Estimation of time-shift models with application to survival calibration in health technology assessment.

    abstract::The incremental life expectancy, defined as the difference in mean survival times between two treatment groups, is a crucial quantity of interest in cost-effectiveness analyses. Usually, this quantity is very difficult to estimate from censored survival data with a limited follow-up period. The paper develops estimati...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.6951

    authors: Titman AC

    更新日期:2016-09-10 00:00:00

  • CoPlot: a tool for visualizing multivariate data in medicine.

    abstract::Many critical questions in medicine require the analysis of complex multivariate data, often from large data sets describing numerous variables for numerous subjects. In this paper, we describe CoPlot, a tool for visualizing multivariate data in medicine. CoPlot is an adaptation of multidimensional scaling (MDS) that ...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.3078

    authors: Bravata DM,Shojania KG,Olkin I,Raveh A

    更新日期:2008-05-30 00:00:00

  • Estimating prediction equations in repeated measures designs.

    abstract::Experimental designs with repeated measures allow response patterns over time (or dose) to be modelled and compared between different homogeneous groups. Issues in data analysis often focus on the pattern of variation of the repeated measures, the appropriateness of a univariate or multivariate analysis, and the shape...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4780100116

    authors: Stanek EJ 3rd,Kline G

    更新日期:1991-01-01 00:00:00

  • Bayesian bivariate meta-analysis of diagnostic test studies using integrated nested Laplace approximations.

    abstract::For bivariate meta-analysis of diagnostic studies, likelihood approaches are very popular. However, they often run into numerical problems with possible non-convergence. In addition, the construction of confidence intervals is controversial. Bayesian methods based on Markov chain Monte Carlo (MCMC) sampling could be u...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.3858

    authors: Paul M,Riebler A,Bachmann LM,Rue H,Held L

    更新日期:2010-05-30 00:00:00

  • The power prior: theory and applications.

    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

    pub_type: 杂志文章

    doi:10.1002/sim.6728

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

    更新日期:2015-12-10 00:00:00