Julious (medical statistics, U. of Sheffield), Say Beng Tan (medicine, Duke-National U. of Singapore) and David Machin (U. of Leicester and U. of Sheffield) describe trials conducted during the early stages of drug development, characterizing them as learning and explaining phases in contrast to the later proving phases. One the points they emphasize, however, is that the trials overlap, rather than one stage ending before the next starts, so trials begun early might still be going on at the end of the entire process. Their topics include sample size calculations for clinical trials, Bayesian and frequentist methods, bio-equivalence studies, dose-response studies, interpreting and applying early phase trial results, and go/no-go criteria. The material could be useful to researchers or advanced students. Annotation ©2010 Book News, Inc., Portland, OR (booknews.com)
Presents an overview of the some of the most common types of trial undertaken in early clinical development. This title describes how information at the end of early phase development can be brought together to facilitate and enhance decisions pertinent to a clinical development programme.
All new medicines and devices undergo early phase trials to assess, interpret and better understand their efficacy, tolerability and safety.
An Introduction to Statistics in Early Phase Trials describes the practical design and analysis of these important early phase clinical trials and provides the crucial statistical basis for their interpretation. It clearly and concisely provides an overview of the most common types of trials undertaken in early phase clinical research and explains the different methodologies used. The impact of statistical technologies on clinical development and the statistical and methodological basis for making clinical and investment decisions are also explained.
- Conveys key ideas in a concise manner understandable by non-statisticians
- Explains how to optimise designs in a constrained or fixed resource setting
- Discusses decision making criteria at the end of Phase II trials
- Highlights practical day-to-day issues and reporting of early phase trials
An Introduction to Statistics in Early Phase Trials is an essential guide for all researchers working in early phase clinical trial development, from clinical pharmacologists and pharmacokineticists through to clinical investigators and medical statisticians. It is also a valuable reference for teachers and students of pharmaceutical medicine learning about the design and analysis of clinical trials.
