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...

Randomized clinical trials are the gold standard for establishing many clinical practice guidelines and are central to evidence based medicine. Obtaining the best evidence through clinical trials must be done within the boundaries of rigorous science and ethical principles. One fundamental principle is that trials should not continue longer than necessary to reach their objectives. Therefore, trials must be monitored for recruitment progress, quality of data, adherence to patient care or prevention standards, and early evidence of benefit or harm. Frequently, a group of external experts,...

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...

Statistical Monitoring of Clinical Trials: Fundamentals for Investigators introduces the investigator and statistician to monitoring procedures in clinical research. Clearly presenting the necessary background with limited use of mathematics, this book increases the knowledge, experience, and intuition of investigations in the use of these important procedures now required by the many clinical research efforts.

The author provides motivated clinical investigators the background, correct use, and interpretation of these monitoring procedures at an elementary statistical level. He...

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...

This book collects and unifies statistical models and methods that have been proposed for analyzing interval-censored failure time data. It provides the first comprehensive coverage of the topic of interval-censored data and complements the books on right-censored data. The focus of the book is on nonparametric and semiparametric inferences, but it also describes parametric and imputation approaches. This book provides an up-to-date reference for people who are conducting research on the analysis of interval-censored failure time data as well as for those who need to analyze...

Lowers the Learning Curve for Physicians and Researchers

The successful Statistical Reasoning in Medicine: The Intuitive P-value Primer, with its novel emphasis on patient and community protection, illustrated the correct use of statistics in health care research for healthcare workers. Through clear explanations and examples, this book provided the non-mathematician with a foundation for understanding the underlying statistical reasoning process in clinical research, the core principles of research design, and the correct use of statistical inference and p-values.

The...

Advances in computers and biotechnology have had a profound impact on biomedical research, and as a result complex data sets can now be generated to address extremely complex biological questions. Correspondingly, advances in the statistical methods necessary to analyze such data are following closely behind the advances in data generation methods. The statistical methods required by bioinformatics present many new and difficult problems for the research community.

This book provides an introduction to some of these new methods. The main biological topics treated include sequence...