Abstract:
:The publication of Fisher's correspondence on statistics has shed new light on his views on randomization. Quotations from this correspondence and from other works of Fisher are used to illustrate the role of randomization in clinical trials. It is concluded that Fisher's views not only are coherent but, despite having been developed over 60 years ago and with particular reference to agricultural experiments, are still relevant to the planning and analysis of clinical trials today.
journal_name
Stat Medjournal_title
Statistics in medicineauthors
Senn Sdoi
10.1002/sim.4780130305subject
Has Abstractpub_date
1994-02-15 00:00:00pages
217-30issue
3eissn
0277-6715issn
1097-0258journal_volume
13pub_type
杂志文章abstract::We obtained maximum likelihood estimates (MLEs) of the proportion cured pi c and mean log survival time mu t for a sample of 4355 patients with intraocular melanoma whose survival times subsequent to treatment were assumed to follow a log-normal distribution. Following stratification by tumour size, MLEs of pi c and m...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.4780090814
更新日期:1990-08-01 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
pub_type: 杂志文章
doi:10.1002/sim.6259
更新日期:2014-11-20 00:00:00
abstract::The U.S. Food and Drug Administration (FDA) has proposed new regulations that address the 'prescribability' and 'switchability' of new formulations of already-approved drugs. These new criteria are known, respectively, as population and individual bioequivalence. Two methods have been proposed in the bioequivalence li...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.1346
更新日期:2003-01-15 00:00:00
abstract::We consider the estimation of parameters in a particular segmented generalized linear model with additive measurement error in predictors, with a focus on linear and logistic regression. In epidemiologic studies segmented regression models often occur as threshold models, where it is assumed that the exposure has no i...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/(sici)1097-0258(19970130)16:2<169::aid-sim
更新日期:1997-01-15 00:00:00
abstract::Longitudinal biomarker data are often collected in studies, providing important information regarding the probability of an outcome of interest occurring at a future time. With many new and evolving technologies for biomarker discovery, the number of biomarker measurements available for analysis of disease progression...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.8687
更新日期:2020-11-20 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
pub_type: 杂志文章
doi:10.1002/1097-0258(20000915/30)19:17/18<2539::aid-s
更新日期:2000-09-15 00:00:00
abstract::Huntington's disease (HD) is a neurodegenerative disorder with a dominant genetic mode of inheritance caused by an expansion of CAG repeats on chromosome 4. Typically, a longer sequence of CAG repeat length is associated with increased risk of experiencing earlier onset of HD. Previous studies of the association betwe...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.5971
更新日期:2014-04-15 00:00:00
abstract::Assessing the QT prolongation potential of a drug is typically done based on pivotal safety studies called thorough QT studies. Model-based estimation of the drug-induced QT prolongation at the estimated mean maximum drug concentration could increase efficiency over the currently used intersection-union test. However,...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.7395
更新日期:2017-10-30 00:00:00
abstract::Rationalization of antibiotic therapy in the management of infectious diseases is helped by a knowledge of the patterns of sensitivity and resistance of bacteria to antibiotics and their possible changes both in time and from one hospital unit to another. In this paper we present the results regarding the sensitivitie...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.2447
更新日期:2006-10-30 00:00:00
abstract::Systematic reviews often provide recommendations for further research. When meta-analyses are inconclusive, such recommendations typically argue for further studies to be conducted. However, the nature and amount of future research should depend on the nature and amount of the existing research. We propose a method ba...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.5524
更新日期:2013-01-15 00:00:00
abstract::The first randomized clinical trial at the National Cancer Institute (NCI), planned in 1954, commenced in 1955 for the treatment of patients with acute leukaemia. The programme in clinical trials at NCI had strong influence from the clinician and administrator, C. Gordon Zubrod, who introduced the randomized clinical ...
journal_title:Statistics in medicine
pub_type: 临床试验,历史文章,杂志文章,随机对照试验
doi:10.1002/sim.4780090803
更新日期:1990-08-01 00:00:00
abstract::The Cardiac Arrythmia Suppression Trial was stopped much earlier than planned. Statistical considerations played a very important role in the decision. Flexible group sequential testing was developed for the trial by implementing a Lan and DeMets procedure with use of the permutation test. We compute P-values from the...
journal_title:Statistics in medicine
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1002/sim.4780090915
更新日期:1990-09-01 00:00:00
abstract::A survey is conducted at w of K selection units or lists, e.g. health care institutions or weeks in a year, to estimate N, the total number of individuals with particular characteristics. Our estimator utilizes two items determined for each survey participant: the number, u, among the w lists in S and the number, j, a...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.3614
更新日期:2009-07-30 00:00:00
abstract:BACKGROUND:The need to deliver interventions targeting multiple diseases in a cost-effective manner calls for integrated disease control efforts. Consequently, maps are required that show where the risk of co-infection is particularly high. Co-infection risk is preferably estimated via Bayesian geostatistical multinomi...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.4243
更新日期:2011-06-30 00:00:00
abstract::A trial of Duchenne muscular dystrophy involved tracking boys of all ages through a one-year baseline period, followed by a one-year trial of leucine versus placebo treatment. In this paper we develop a model for a total-muscle-strength score that uses the data of the extended baseline period in the evaluation of the ...
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.4780050304
更新日期:1986-05-01 00:00:00
abstract::In the last decade or so, pharmaceutical drug development activities in the area of new antibacterial drugs for treating serious bacterial diseases have declined, and at the same time, there are worries that the increased prevalence of antibiotic-resistant bacterial infections, especially the increase in drug-resistan...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.6233
更新日期:2014-11-10 00:00:00
abstract::In the recent two decades, data mining methods for signal detection have been developed for drug safety surveillance, using large post-market safety data. Several of these methods assume that the number of reports for each drug-adverse event combination is a Poisson random variable with mean proportional to the unknow...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.6510
更新日期:2015-08-30 00:00:00
abstract::This paper concerns the statistical analysis of certain binary data arising in molecular studies of cancer. In allelic-loss experiments, tumour cell genomes are analysed at informative molecular marker loci to identify deleted chromosomal regions. The resulting binary data are used to infer properties of putative supp...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/(sici)1097-0258(19980715)17:13<1425::aid-s
更新日期:1998-07-15 00:00:00
abstract::This paper models monthly AIDS diagnosis counts in terms of smooth secular trend, calendar month effects, and the number of workdays per month. A parameterization of month effects allows separation of true seasonal effects from a linear trend over the calendar year and an arbitrary June effect. There is strong evidenc...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.4780131905
更新日期:1994-10-15 00:00:00
abstract::A good measure of field vaccine efficacy should evaluate the direct protective effect of vaccination on the person who receives the vaccine. The conventional estimator for vaccine efficacy depends on population level factors that are either unrelated or indirectly related to the direct biological action of the vaccine...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.4780120309
更新日期:1993-02-01 00:00:00
abstract::A new goodness-of-fit test for the logistic regression model is proposed. It exploits the property of this model that when it is correct, i.e. not misspecified, the parameter estimates are (asymptotically) invariant under reweighting the observations by weights wi that are a function of the binary (0/1) outcomes yi. M...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.1997
更新日期:2005-01-15 00:00:00
abstract::In genetic and genomic studies, gene-environment (G×E) interactions have important implications. Some of the existing G×E interaction methods are limited by analyzing a small number of G factors at a time, by assuming linear effects of E factors, by assuming no data contamination, and by adopting ineffective selection...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.6609
更新日期:2015-12-30 00:00:00
abstract::Linear mixed effects (LME) models are increasingly used for analyses of biological and biomedical data. When the multivariate normal assumption is not adequate for an LME model, then a robust estimation approach is preferable to the maximum likelihood one. M-estimators were considered before for robust estimation of t...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.4169
更新日期:2011-06-30 00:00:00
abstract::Randomized clinical trial designs commonly include one or more planned interim analyses. At these times an external monitoring committee reviews the accumulated data and determines whether it is scientifically and ethically appropriate for the study to continue. With failure-time endpoints, it is common to schedule an...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.843
更新日期:2001-07-30 00:00:00
abstract::While there has been extensive research developing gene-environment interaction (GEI) methods in case-control studies, little attention has been given to sparse and efficient modeling of GEI in longitudinal studies. In a two-way table for GEI with rows and columns as categorical variables, a conventional saturated int...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.6281
更新日期:2014-12-20 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
pub_type: 杂志文章,评审
doi:10.1002/(SICI)1097-0258(19960615)15:11<1069::AID-S
更新日期:1996-06-15 00:00:00
abstract::In US states with small subpopulations, the observed mortality rates are often zero, particularly among young ages. Because in life tables, death rates are reported mostly on a log scale, zero mortality rates are problematic. To overcome the observed zero death rates problem, appropriate probability models are used. U...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.6385
更新日期:2015-05-20 00:00:00
abstract::The analysis of multivariate time-to-event (TTE) data can become complicated due to the presence of clustering, leading to dependence between multiple event times. For a long time, (conditional) frailty models and (marginal) copula models have been used to analyze clustered TTE data. In this article, we propose a gene...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.8506
更新日期:2020-05-30 00:00:00
abstract::Group sequential hypothesis testing is now widely used to analyze prospective data. If Monte Carlo simulation is used to construct the signaling threshold, the challenge is how to manage the type I error probability for each one of the multiple tests without losing control on the overall significance level. This paper...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.6805
更新日期:2016-04-30 00:00:00
abstract::Clinical trials with multiple endpoints incur increased familywise type I errors. The Bonferroni correction is a common method used to modify the p-values to account for multiple significance testing. For independent endpoints the Bonferroni method is slightly conservative whereas with high correlation the conservatis...
journal_title:Statistics in medicine
pub_type: 杂志文章
doi:10.1002/sim.4780100712
更新日期:1991-07-01 00:00:00