Sample size tables for clinical studies(third edition)

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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 analysing clinical studies is a very complicated business and this book provides indispensible factual information.

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6 Z+ }! y, t4 H: X  y1 U+ fIt is now more than 20 years since the first edition of this book and 10 years from the second. The need for evidence-based estimates of the required size of a study is now universally recognized. Since the second edition the methodology for sample-size calculation has been widely extended, which is the main reason for a third edition. A second reason is the vastly improved computing power available. For the first edition, the tabulations were extensive to obviate separate calculations. A computer program to extend the range of the tables was available for the second edition.

This edition comes with sample size software , which we hope will give the user even greater flexibility and easy access to a wide range of designs, and allow design parameters to be tailored more readily to specific problems. Further, as some early phase designs are adaptive in nature and require knowledge of earlier patients’ response to determine the relevant options for the next patient, a (secure) database is provided for these.
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Designing modern clinical research studies requires the involvement of multidisciplinary teams, with the process of sample size determination not being something that can be done by the statistician alone. So while software is available that can compute sample sizes (even from the internet), we feel that it is necessary that such software be complemented with a book that clearly explains and illustrates the methodology, along with tables. Feedback
from users of earlier editions suggests that this can facilitate planning discussions within the research team.
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Thus a major consideration has been to present the details, which are often complex, as clearly as possible and to illustrate these with appropriate examples. One objective of this approach is to encourage the wider use of sample size issues at the design stage in areas such as laboratory studies, which have been relatively neglected compared to epidemiological studies and clinical trials.

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