PREFACE TO THE FIRST EDITION

This book was written for those involved in clinical research and who may, from time to time, need a guide to help demystify some of the most commonly used statistical methods encountered in our profession.

All too often, I have heard medical directors of clinical research departments express frustration at seemingly cryptic statistical methods sections of protocols which they are responsible for approving. Other nonstatisticians, including medical monitors, investigators, clinical project managers, medical writers and regulatory personnel, often voice similar sentiment when it comes to statistics, despite the profound reliance upon statistical methods in the success of the clinical program. For these people, I offer ...

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