This book provides statisticians and researchers with the statistical tools - equations, formulae and numerical tables - to design and plan clinical studies and carry out accurate, reliable and reproducible analysis of the data so obtained. There is no way around this as incorrect procedure in clinical studies means that the researcher's paper will not be accepted by a peer-reviewed journal. Planning and analyzing clinical studies is a very complicated business and this book provides indispensable factual information.

Basic design considerations -- Distributions and confidence intervals -- Comparing two independent groups for binary data -- Comparing two independent groups for ordered categorical data -- Comparing two independent groups for continuous data -- Cluster designs, repeated measures data and more than two groups -- Comparing paired groups for binary, ordered categorical and continuous outcomes -- Comparing survival curves -- Equivalence -- Confidence intervals -- Post-marketing surveillance -- The correlation coefficient -- Reference intervals and receiver operating curves -- Observer agreement studies -- Dose finding studies -- Phase II trials -- Sample size software (SSS).