Clinical Research

The book is divided into five parts: Part 1 provides an academic perspective that focuses on the specific preparation required in the final years of study to embark on a successful career in the pharmaceutical and biomedical industries. In Part 2, industry experts discuss employment possibilities all along the drug or product life cycle, from discovery research and development to commercialization. Part 3 follows, highlighting opportunities in support functions such as regulatory affairs or quality assurance. Part 4 focuses on additional opportunities in the wider biomedical sector, while Part 5 contains practical tips and training opportunities for entering the pharmaceutical and biomedical industries. In the epilogue, the authors reflect on this fascinating field and its career prospects.

2 books in 1! Half pharmacology, half dosage calculations--plus an intensive, yet clear & simple review of basic math! Here's the must-have knowledge and guidance you need to gain a solid understanding of pharmacology and the safe administration of medications in one text. A body systems approach to pharmacology with a basic math review and a focus on drug classifications prepare you for administering specific drugs in the clinical setting.

Now available online.

The AMA Manual of Style continues to provide editorial support to the medical and scientific publishing community. Since the 1998 publication of the 9th edition, however, the world of medical publishing has rapidly modernized, and the intersection of research and publishing has become ever more complex. The 10th edition of the AMA Manual of Style brings this definitive manual into the 21st century with a broadened international perspective. In doing so, the 10th edition has expanded its electronic guidelines, with the understanding that authors now routinely submit articles through online systems and often cite Web-only content. The new edition examines research ethics and editorial independence and features new material on indexing and searching as well as medical nomenclature. Extensively peer-reviewed, the 10th edition provides a welcome and improved standard for the growing international medical community. Also available in an online version!

Survival data analysis is a very broad field of statistics, encompassing a large variety of methods used in a wide range of applications, and in particular in medical research. During the last twenty years, several extensions of "classical" survival models have been developed to address particular situations often encountered in practice. This book aims to gather in a single reference the most commonly used extensions, such as frailty models (in case of unobserved heterogeneity or clustered data), cure models (when a fraction of the population will not experience the event of interest), competing risk models (in case of different types of event), and joint survival models for a time-to-event endpoint and a longitudinal outcome. Features Presents state-of-the art approaches for different advanced survival models including frailty models, cure models, competing risk models and joint models for a longitudinal and a survival outcome Uses consistent notation throughout the book for the different techniques presented Explains in which situation each of these models should be used, and how they are linked to specific research questions Focuses on the understanding of the models, their implementation, and their interpretation, with an appropriate level of methodological development for masters students and applied statisticians Provides references to existing R packages and SAS procedure or macros, and illustrates the use of the main ones on real datasets This book is primarily aimed at applied statisticians and graduate students of statistics and biostatistics. It can also serve as an introductory reference for methodological researchers interested in the main extensions of classical survival analysis.

The world is awash in data. This volume of data will continue to increase. In the pharmaceutical industry, much of this data explosion has happened around biomarker data. Great statisticians are needed to derive understanding from these data. This book will guide you as you begin the journey into communicating, understanding and synthesizing biomarker data. -From the Foreword, Jared Christensen, Vice President, Biostatistics Early Clinical Development, Pfizer, Inc. Biomarker Analysis in Clinical Trials with R offers practical guidance to statisticians in the pharmaceutical industry on how to incorporate biomarker data analysis in clinical trial studies. The book discusses the appropriate statistical methods for evaluating pharmacodynamic, predictive and surrogate biomarkers for delivering increased value in the drug development process. The topic of combining multiple biomarkers to predict drug response using machine learning is covered. Featuring copious reproducible code and examples in R, the book helps students, researchers and biostatisticians get started in tackling the hard problems of designing and analyzing trials with biomarkers. Features: Analysis of pharmacodynamic biomarkers for lending evidence target modulation. Design and analysis of trials with a predictive biomarker. Framework for analyzing surrogate biomarkers. Methods for combining multiple biomarkers to predict treatment response. Offers a biomarker statistical analysis plan. R code, data and models are given for each part: including regression models for survival and longitudinal data, as well as statistical learning models, such as graphical models and penalized regression models.

This book illustrates numerous statistical practices that are commonly used by medical researchers, but which have severe flaws that may not be obvious.  For each example, it provides one or more alternative statistical methods that avoid misleading or incorrect inferences being made. The technical level is kept to a minimum to make the book accessible to non-statisticians. At the same time, since many of the examples describe methods used routinely by medical statisticians with formal statistical training, the book appeals to a broad readership in the medical research community.

Correctly understanding and using medical statistics is a key skill for all medical students and health professionals. In an informal and friendly style, Medical Statistics from Scratch provides a practical foundation for everyone whose first interest is probably not medical statistics. Keeping the level of mathematics to a minimum, it clearly illustrates statistical concepts and practice with numerous real-world examples and cases drawn from current medical literature. Medical Statistics from Scratch is an ideal learning partner for all medical students and health professionals needing an accessible introduction, or a friendly refresher, to the fundamentals of medical statistics.