Historical and methodological developments in clinical trials at the National Cancer Institute.

abstract：:The cost and efficiency of training clinical centre staff and of duplicate data entry in clinical trials is reviewed. Training is an essential component of quality assurance programmes and it is usually carried out at regular intervals in long-term clinical trials. Initial training of staff and regular retraining is i...

journal_title：Statistics in medicine

authors： Neaton JD,Duchene AG,Svendsen KH,Wentworth D

更新日期：1990-01-01 00:00:00

abstract：:We give up-to-date methods for estimating the age-specific incidence of a disease and for estimating the effect of risk factors. We recommend taking age as the basic time scale of the analysis; then, the hazard function can be interpreted as the age-specific incidence of the disease. This choice raises a delayed entry...

journal_title：Statistics in medicine

authors： Commenges D,Letenneur L,Joly P,Alioum A,Dartigues JF

更新日期：1998-09-15 00:00:00

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

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

更新日期：1997-07-15 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

authors： Wu C,Shi X,Cui Y,Ma S

更新日期：2015-12-30 00:00:00

abstract：:Confounding is a major concern in observational studies. To adjust for confounding bias, the potential confounder(s) for a study must first be identified and measured. But this is not always possible. The unmeasured factors may also exhibit effect modification, and this further complicates the situation. In this paper...

journal_title：Statistics in medicine

authors： Lee WC

更新日期：2011-04-30 00:00:00

abstract：:In conventional survival analysis there is an underlying assumption that all study subjects are susceptible to the event. In general, this assumption does not adequately hold when investigating the time to an event other than death. Owing to genetic and/or environmental etiology, study subjects may not be susceptible ...

journal_title：Statistics in medicine

authors： Chen CH,Tsay YC,Wu YC,Horng CF

更新日期：2013-10-30 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：:In many countries, the monitoring of child growth does not occur in a regular manner, and instead, we may have to rely on sporadic observations that are subject to substantial measurement error. In these countries, it can be difficult to identify patterns of poor growth, and faltering children may miss out on essentia...

journal_title：Statistics in medicine

authors： Anderson C,Xiao L,Checkley W

更新日期：2019-08-30 00:00:00

abstract：:In order for national statistical offices to maintain the trust of the public to collect data and publish statistics of importance to society and decision-making, it is imperative that respondents (persons or establishments) be guaranteed privacy and confidentiality in return for providing requested confidential data....

journal_title：Statistics in medicine

authors： Gonzalez JF Jr,Cox LH

更新日期：2005-02-28 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：:We present a new method of detection and inference for spatial clusters of a disease. To avoid ad hoc procedures to test for clustering, we have a clearly defined alternative hypothesis and our test statistic is based on the likelihood ratio. The proposed test can detect clusters of any size, located anywhere in the s...

journal_title：Statistics in medicine

authors： Kulldorff M,Nagarwalla N

更新日期：1995-04-30 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：:In some randomized controlled trials, subjects with a better prognosis may be diverted into the treatment group. This subverting of randomization results in an unobserved non-compliance with the originally intended treatment assignment. Consequently, the estimate of treatment effect from these trials may be biased. Th...

journal_title：Statistics in medicine

authors： Marcus SM

更新日期：2001-02-28 00:00:00

abstract：:In recent years, follow-on biological products (biosimilars) have received much attention from both the biotechnology industry and the regulatory agencies, especially after the passage of the 2010 healthcare reform bill. Unlike the traditional small-molecule drug products, the development of biological products is not...

journal_title：Statistics in medicine

authors： Yang J,Zhang N,Chow SC,Chi E

更新日期：2013-02-10 00:00:00

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

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

更新日期：2005-11-30 00:00:00

abstract：:The lifetime risk of a clinical condition is the probability of onset of the condition during one's lifespan. Recent advances in Alzheimer's disease (AD) research have identified screening tests for biomarkers that can identify persons who are in the earliest stages of the AD process but who do not yet have any clinic...

journal_title：Statistics in medicine

authors： Brookmeyer R,Abdalla N

更新日期：2019-04-30 00:00:00

abstract：:Phase II studies in oncology are frequently conducted as two-stage single-arm trials with a binary endpoint indicating tumor response. As a common feature of these designs, the sample sizes of the two stages and the decision rules for the interim and the final analysis have to be pre-specified and adhered to strictly ...

journal_title：Statistics in medicine

authors： Englert S,Kieser M

更新日期：2015-06-15 00:00:00

abstract：:Cancer patients, chronic kidney disease patients, and subjects infected with HIV are routinely monitored over time using biomarkers that represent key health status indicators. Furthermore, biomarkers are frequently used to guide initiation of new treatments or to inform changes in intervention strategies. Since key m...

journal_title：Statistics in medicine

authors： Saha-Chaudhuri P,Heagerty PJ

更新日期：2018-08-15 00:00:00

abstract：:To study the effect of a mega hydropower dam in southwest Ethiopia on malaria incidence, we have set up a longitudinal study. To gain insight in temporal and spatial aspects, that is, in time (period  =  year-season combination) and location (village), we need models that account for these effects. The frailty model w...

journal_title：Statistics in medicine

authors： Getachew Y,Janssen P,Yewhalaw D,Speybroeck N,Duchateau L

更新日期：2013-08-15 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

abstract：:Sexually transmitted infections (STIs) with Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis are among the most common infectious diseases in the United States, disproportionately affecting young women. Because a significant portion of the infections present no symptoms, infection control relies...

journal_title：Statistics in medicine

authors： Li Z,Liu H,Tu W

更新日期：2015-09-10 00:00:00

abstract：:The primary purpose of a disease surveillance system is to provide data for the detection of changes in the incidence of the disease. Methods for the analysis of data from surveillance systems are reviewed. A new procedure is proposed for use when the system includes geographically dispersed reporting units, such as h...

journal_title：Statistics in medicine

authors： Raubertas RF

更新日期：1989-03-01 00:00:00

abstract：:The present study investigates the performance of several statistical tests to detect publication bias in diagnostic meta-analysis by means of simulation. While bivariate models should be used to pool data from primary studies in diagnostic meta-analysis, univariate measures of diagnostic accuracy are preferable for t...

journal_title：Statistics in medicine

authors： Bürkner PC,Doebler P

更新日期：2014-08-15 00:00:00

abstract：:Sample size planning should reflect the primary objective of a trial. If the primary objective is prediction, the sample size determination should focus on prediction accuracy instead of power. We present formulas for the determination of training set sample size for survival prediction. Sample size is chosen to contr...

journal_title：Statistics in medicine

authors： Götte H,Zwiener I

更新日期：2013-02-28 00:00:00

abstract：:The construction, validation and updating of a prognostic model for kidney graft survival is reported using data from the Eurotransplant database. First, a model is constructed for data from transplantations in the period 1984 to 1987. The model is later updated for the 1988 1990 data. The first data set was randomly ...

journal_title：Statistics in medicine

authors： Van Houwelingen HC,Thorogood J

更新日期：1995-09-30 00:00:00

abstract：:Treatment effects for multiple outcomes can be meta-analyzed separately or jointly, but no systematic empirical comparison of the two approaches exists. From the Cochrane Library of Systematic Reviews, we identified 45 reviews, including 1473 trials and 258,675 patients, that contained two or three univariate meta-ana...

journal_title：Statistics in medicine

authors： Trikalinos TA,Hoaglin DC,Schmid CH

更新日期：2014-04-30 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

authors： Tran TMP,Abrams S,Braekers R

更新日期：2020-05-30 00:00:00

abstract：:Small but important therapeutic effects of new treatments can be most efficiently detected through the study of large randomized prospective series of patients. Such large scale clinical trials are nowadays commonplace. The alternative is years of polemic and debate surrounding several trials each too small to detect ...

journal_title：Statistics in medicine

authors： McPherson K

更新日期：1982-01-01 00:00:00

abstract：:In genetic association studies, it is typically thought that genetic variants and environmental variables jointly will explain more of the inheritance of a phenotype than either of these two components separately. Traditional methods to identify gene-environment interactions typically consider only one measured enviro...

journal_title：Statistics in medicine

authors： Pashova H,LeBlanc M,Kooperberg C

更新日期：2013-01-30 00:00:00

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

authors： Rosner B,Glynn RJ

更新日期：2007-02-10 00:00:00