A new approach to designing phase I-II cancer trials for cytotoxic chemotherapies.

abstract：:In this commentary, we revisit Sir Austin Bradford Hill's seminal Alfred Watson Memorial Lecture in 1962 through the eyes of two practicing biostatisticians of the current era. We summarize some eternal takeaway messages from Hill's lecture regarding observations and experiments translated through the modern lexicon o...

journal_title：Statistics in medicine

authors： Dempsey W,Mukherjee B

更新日期：2021-01-15 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：:The time-dependent change of HIV particle load, i.e. HIV dynamics, is likely to be controlled by a multitude of quantitative trait loci (QTL) that interact with each other as well as with various developmental and environmental factors in a coordinated manner. In this article, we have derived a new statistical model f...

journal_title：Statistics in medicine

authors： Wu S,Yang J,Wu R

更新日期：2006-11-30 00:00:00

abstract：:Ewell and Ibrahim derived the large sample distribution of the logrank statistic under general local alternatives. Their asymptotic results enable us to extend several group sequential designs which allow for early stopping in favour of the null hypothesis to the setting in which the cure rate model is appropriate. In...

journal_title：Statistics in medicine

authors： Patricia Bernardo MV,Ibrahim JG

更新日期：2000-11-30 00:00:00

abstract：:Comparative effectiveness research represents the kind of research that arguably more directly affects clinical practice and policy. It includes observational studies, clinical trials, and systematic syntheses of existing literature. In this commentary, I argue for the ongoing and critical role of randomization in com...

journal_title：Statistics in medicine

authors： Lauer MS

更新日期：2012-11-10 00:00:00

abstract：:Austin Bradford Hill was once a friend to The Lancet, but, as occasionally happens, friends fall out. The great legacy of his association with the journal, however, was Principles of Medical Statistics. As each edition was succeeded by another--the first in 1937, the last in 1991--he seemed to shift his view about the...

journal_title：Statistics in medicine

authors： Horton R

更新日期：2000-12-15 00:00:00

abstract：:There is growing interest in how best to adapt and readapt treatments to individuals to maximize clinical benefit. In response, adaptive treatment strategies (ATS), which operationalize adaptive, sequential clinical decision making, have been developed. From a patient's perspective an ATS is a sequence of treatments, ...

journal_title：Statistics in medicine

authors： Almirall D,Compton SN,Gunlicks-Stoessel M,Duan N,Murphy SA

更新日期：2012-07-30 00:00:00

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. Howev...

journal_title：Statistics in medicine

authors： Lachin JM

更新日期：2004-05-30 00:00:00

abstract：:A mixture model incorporating long-term survivors has been adopted in the field of biostatistics where some individuals may never experience the failure event under study. The surviving fractions may be considered as cured. In most applications, the survival times are assumed to be independent. However, when the survi...

journal_title：Statistics in medicine

authors： Yau KK,Ng AS

更新日期：2001-06-15 00:00:00

abstract：:The relative importance of prognostic factors in regression can be measured either by standardized regression coefficients or by percentages of explained variation in a dependent variable. One advantage of using explained variation is the direct comparability of qualitative prognostic factors with others, or of groups...

journal_title：Statistics in medicine

authors： Schemper M

更新日期：1993-12-30 00:00:00

abstract：:We consider bivariate survival times for heterogeneous populations, where heterogeneity induces deviations in an individual's risk of an event as well as associations between survival times. The heterogeneity is characterized by a bivariate frailty model. We measure the heterogeneity effects through deviations associa...

journal_title：Statistics in medicine

authors： Xue X,Ding Y

更新日期：1999-04-30 00:00:00

abstract：:We consider using observational data to estimate the effect of a treatment on disease recurrence, when the decision to initiate treatment is based on longitudinal factors associated with the risk of recurrence. The effect of salvage androgen deprivation therapy (SADT) on the risk of recurrence of prostate cancer is in...

journal_title：Statistics in medicine

authors： Kennedy EH,Taylor JM,Schaubel DE,Williams S

更新日期：2010-11-10 00:00:00

abstract：:We study the competing risks model and show that the cause j cumulative incidence function integrated from 0 to τ has a natural interpretation as the expected number of life years lost due to cause j before time τ. This is analogous to the τ-restricted mean lifetime, which is the survival function integrated from 0 to...

journal_title：Statistics in medicine

authors： Andersen PK

更新日期：2013-12-30 00:00:00

abstract：:Patients who switch treatment groups in randomized clinical trials can cause problems in the interpretation of the results. Although the intention-to-treat method is recognized as being the most reliable analysis, it may result in an underestimate of the treatment effect if there have been patients who switch treatmen...

journal_title：Statistics in medicine

authors： Law MG,Kaldor JM

更新日期：1996-10-15 00:00:00

abstract：:Binary matched-pairs data occur commonly in longitudinal studies, such as in cross-over experiments. Many analyses for comparing the matched probabilities of a particular outcome do not utilize pairs having the same outcome for each observation. An example is McNemar's test. Some methodologists find this to be counter...

journal_title：Statistics in medicine

authors： Agresti A,Min Y

更新日期：2004-01-15 00:00:00

abstract：:In contrast to other models for ordinal data, the continuation ratio model can be fitted with standard statistical software. This makes it particularly appropriate for large clinical trials with ordinal response variables. In addition, when the trials are longitudinal, this model can be applied to individual responses...

journal_title：Statistics in medicine

authors： Lindsey JK,Jones B,Ebbutt AF

更新日期：1997-12-30 00:00:00

abstract：:We propose a two-step procedure to personalize drug dosage over time under the framework of a log-linear mixed-effect model. We model patients' heterogeneity using subject-specific random effects, which are treated as the realizations of an unspecified stochastic process. We extend the conditional quadratic inference ...

journal_title：Statistics in medicine

authors： Zhu X,Qu A

更新日期：2016-10-30 00:00:00

abstract：:Often in randomized clinical trials and observational studies in occupational and environmental health, a non-negative continuously distributed response variable denoting some metabolites of environmental toxicants is measured in treatment and control groups. When observations occur in both unexposed and exposed subje...

journal_title：Statistics in medicine

authors： Chu H,Nie L,Kensler TW

更新日期：2008-06-15 00:00:00

abstract：:Biostatisticians have frequently uncritically accepted the measurements provided by their medical colleagues engaged in clinical research. Such measures often involve considerable loss of information. Particularly, unfortunate is the widespread use of the so-called 'responder analysis', which may involve not only a lo...

journal_title：Statistics in medicine

authors： Senn S,Julious S

更新日期：2009-11-20 00:00:00

abstract：:Sam Greenhouse joined the Census Bureau as a clerk at an interesting time period for the agency. The first use of sampling in the decennial census occurred in 1940. There was a major expansion of the amount of data collected. The organization of the Census Bureau underwent radical changes, including the growth of the ...

journal_title：Statistics in medicine

authors： Keller J,Clark CZ

更新日期：2003-11-15 00:00:00

abstract：:We propose a new design for dose finding for cytotoxic agents in two ordered groups of patients. By ordered groups, we mean that prior to the study there is clinical information that would indicate that for a given dose one group would be more susceptible to toxicities than patients in the other group. The designs are...

journal_title：Statistics in medicine

authors： Conaway MR,Wages NA

更新日期：2017-01-30 00:00:00

abstract：:For the analysis of time to event data in contraceptive studies when individuals are subject to competing causes for discontinuation, some authors have recently advocated the use of the cumulative incidence rate as a more appropriate measure to summarize data than the complement of the Kaplan-Meier estimate of discont...

journal_title：Statistics in medicine

authors： Farley TM,Ali MM,Slaymaker E

更新日期：2001-12-15 00:00:00

abstract：:We review two recent trends: the emergence of evidence-based medicine and the growing use of Bayesian statistics in medical applications. Evidence-based medicine requires an integrated assessment of the available evidence, and associated uncertainty, but there is also an emphasis on decision-making, for individual pat...

journal_title：Statistics in medicine

authors： Ashby D,Smith AF

更新日期：2000-12-15 00:00:00

abstract：:Summarizing the information of many studies using a meta-analysis becomes more and more important, also in the field of diagnostic studies. The special challenge in meta-analysis of diagnostic accuracy studies is that in general sensitivity and specificity are co-primary endpoints. Across the studies both endpoints ar...

journal_title：Statistics in medicine

authors： Zapf A,Hoyer A,Kramer K,Kuss O

更新日期：2015-12-20 00:00:00

abstract：:Inference for randomized clinical trials is generally based on the assumption that outcomes are independently and identically distributed under the null hypothesis. In some trials, particularly in infectious disease, outcomes may be correlated. This may be known in advance (e.g. allowing randomization of family member...

journal_title：Statistics in medicine

authors： Proschan M,Follmann D

更新日期：2008-03-15 00:00:00

abstract：:Standard methods for analysing survival data or case-control data normally concern factors affecting a subject as a whole. However, in a study of a condition that might develop in one or both of a pair of bodily organs information on response and on covariates may be available for each separately. This information can...

journal_title：Statistics in medicine

authors： Whitehead J,Dorse C

更新日期：1988-05-01 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：:Assessing and comparing the performance of correlated predictive scores are of current interest in precision medicine. Given the limitations of available theoretical approaches for assessing and comparing the predictive accuracy, numerical methods are highly desired which, however, have not been systematically develop...

journal_title：Statistics in medicine

authors： Zhang Y,Shao Y

更新日期：2020-09-10 00:00:00

abstract：:The serial dilution assay (for example, an in vitro antimicrobic susceptibility test or a serum antibody titer assay) is an important technique in biomedical research. The structure of the experiment forces grouping of the threshold concentrations into intervals. Statistical methods to analyse threshold concentrations...

journal_title：Statistics in medicine

authors： Hamilton MA,Rinaldi MG

更新日期：1988-04-01 00:00:00

abstract：:In this paper the following problem of clinical research is explored. Several potential new treatments are available for use against a certain disease. These are evaluated in a series of pilot studies which will constitute phase II clinical trials. The most promising will then be compared with a standard treatment in ...

journal_title：Statistics in medicine

authors： Whitehead J

更新日期：1986-09-01 00:00:00