Preface

Planning, developing, and implementing clinical trials, have become an important and integral part of life. More and more efforts and care go into conducting various clinical trials as they have been responsible in making key advances in medicine and treatments to different illnesses. Today, clinical trials have become mandatory in the development and evaluation of modern drugs and in identifying the association of risk factors to diseases. Due to the complexity of various issues surrounding clinical trials, regulatory agencies oversee their approval and also ensure impartial review. The main purpose of this two-volume handbook is to provide a detailed exposition of historical developments and also to highlight modern advances on methods and analysis for clinical trials.

It is important to mention that the four-volume Wiley Encyclopedia of Clinical Trials served as a basis for this handbook. While many pertinent entries from this Encyclopedia have been included here, a number of them have been updated to reflect recent developments on their topics. Some new articles detailing modern advances in statistical methods in clinical trials and their applications have also been included.

A volume of this size and nature cannot be successfully completed without the cooperation and support of the contributing authors, and my sincere thanks and gratitude go to all of them. Thanks are also due to Mr. Steve Quigley and Ms. Sari Friedman (of John Wiley & Sons, Inc.) for their keen interest in this project from day one, as well as for their support and constant encouragement (and, of course, occasional nudges, too) throughout the course of this project. Careful and diligent work of Mrs. Debbie Iscoe in the typesetting of this volume and of Angioline Loredo at the production state, is gratefully acknowledged. Partial financial support of the Natural Sciences and Engineering Research Council of Canada also assisted in the preparation of this handbook, and this support is much appreciated.

This is the seventh in a series of handbooks on methods and applications of statistics. While the first handbook has focused on life and health sciences, the second handbook has focused on business, finance, and management sciences, the third has focused on engineering, quality control, and physical sciences, the fourth has focused on behavioral and social sciences, the fifth has focused on atmospheric and earth sciences, and the sixth handbook has concentrated on methods and applications of statistics to clinical trials. This is the second of two volumes describing in detail statistical developments concerning clinical trials, focusing specifically on planning, analysis, and inferential methods.

It is my sincere hope that this handbook and the others in the series will become basic reference resources for those involved in these fields of research!

PROF. N. BALAKRISHNAN
McMASTER UNIVERSITY

Hamilton, Canada
February 2014