One of the most challenging issues for clinical trial investigators, sponsors, and regulatory officials is the interpretation of experimental results that are composed of the results of multiple statistical analyses. These analyses may include the effect of therapy on multiple endpoints, the assessment of a subgroup analysis, and the evaluation of a dose-response relationship in complex mixtures. Multiple Analyses in Clinical Trials: Fundamentals for Clinical Investigators is an essentially nonmathematical discussion of the problems posed by the execution of multiple analyses in clinical...
One of the most challenging issues for clinical trial investigators, sponsors, and regulatory officials is the interpretation of experimental results ...
In survival analysis there has long been a need for models that goes beyond the Cox model as the proportional hazards assumption often fails in practice. This book studies and applies modern flexible regression models for survival data with a special focus on extensions of the Cox model and alternative models with the specific aim of describing time-varying effects of explanatory variables. One model that receives special attention is Aalen's additive hazards model that is particularly well suited for dealing with time-varying effects. The book covers the use of residuals and resampling...
In survival analysis there has long been a need for models that goes beyond the Cox model as the proportional hazards assumption often fails in pra...
Both humanitarian and commercial considerations have spurred intensive search for methods to reduce the time and cost required to develop new therapies. The identification and use of surrogate endpoints, i.e., measures that can replace or supplement other endpoints in evaluations of experimental treatments or other interventions, is a general strategy that has stimulated both enthusiasm and skepticism. Surrogate endpoints are useful when they can be measured earlier, more conveniently, or more frequently than the "true" endpoints of primary interest. Regulatory agencies around the globe,...
Both humanitarian and commercial considerations have spurred intensive search for methods to reduce the time and cost required to develop new thera...
Most traits in nature and of importance to agriculture are quantitatively inherited. These traits are di?cult to study due to the complex nature of their inheritance. However, recent developments of genomic technologies provide a revolutionary means for unraveling the secrets of genetic variation in quantitative traits. Genomic te- nologies allow the molecular characterization of polymorphic markers throughout the entire genome that are then used to identify and map the genes or quantitative trait loci (QTLs) underlying a quantitative trait based on linkage analysis. Statistical analysis is a...
Most traits in nature and of importance to agriculture are quantitatively inherited. These traits are di?cult to study due to the complex nature of th...
In the field of molecular evolution, inferences about past evolutionary events are made using molecular data from currently living species. With the availability of genomic data from multiple related species, molecular evolution has become one of the most active and fastest growing fields of study in genomics and bioinformatics.
Most studies in molecular evolution rely heavily on statistical procedures based on stochastic process modelling and advanced computational methods including high-dimensional numerical optimization and Markov Chain Monte Carlo. This book provides an overview...
In the field of molecular evolution, inferences about past evolutionary events are made using molecular data from currently living species. With th...
ButIacceptedtheinvitation.Key?tz'ssuggestionthatweincorporatesome of my earlier work on matrix population models seemed like a good way to complement the methods presented in the book, and to expand the range of their applications. I am a demographer of plants and nonhuman animals. Some would call this an oxymoron, since the Greek rootdemos refers to people, and that's us. But there are precedents for taking more inclusive de?nitions of the Greek.Ecologyandeconomics, forexample, bothcomefromtherootoikos, referring to the household. Interpretingdemos as referring to individuals, whether they...
ButIacceptedtheinvitation.Key?tz'ssuggestionthatweincorporatesome of my earlier work on matrix population models seemed like a good way to complement ...
Bioconductor is a widely used open source and open development software project for the analysis and comprehension of data arising from high-throughput experimentation in genomics and molecular biology. Bioconductor is rooted in the open source statistical computing environment R.
This volume's coverage is broad and ranges across most of the key capabilities of the Bioconductor project, including importation and preprocessing of high-throughput data from microarray, proteomic, and flow cytometry platforms:
Curation and delivery of biological metadata for use in statistical...
Bioconductor is a widely used open source and open development software project for the analysis and comprehension of data arising from high-throug...
Proportional hazards models and their extensions (models with ti- dependent covariates, models with time dependent regression co- cients, models with random coe?cients and any mixture of these) can be used to characterize just about any applied problem to which the techniques of survival analysis are appropriate. This simple obser- tion enables us to ?nd an elegant statistical expression for all plausible practical situations arising in the analysis of survival data. We have a single unifying framework. In consequence, a solid understanding of the framework itself o?ers the statistician the...
Proportional hazards models and their extensions (models with ti- dependent covariates, models with time dependent regression co- cients, models with ...
This book emphasizes dose selection issues from a statistical point of view. It presentsstatisticalapplicationsinthedesignandanalysisofdose-responsestudies. The importance of this subject can be found from the International Conference on Harmonization (ICH) E4 Guidance document. Establishing the dose-response relationship is one of the most important act- ities in developing a new drug. A clinical development program for a new drug can be broadly divided into four phases - namely Phases I, II, III, and IV. Phase I clinical trials are designed to study the clinical pharmacology. Information -...
This book emphasizes dose selection issues from a statistical point of view. It presentsstatisticalapplicationsinthedesignandanalysisofdose-responsest...
The approach taken in this book is to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows that the joint distribution of the test statistics at different analysis times is asymptotically multivariate normal with the correlation structure of Brownian motion ("the B-value") irrespective of the test statistic. The so-called B-value approach to monitoring allows us to use, for different...
The approach taken in this book is to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the...
