This book deals with randomization in clinical trials. Currently trials use permuted blocks randomization almost exclusively. Many researchers are aware of the drawbacks to this fatally flawed method, and while many are unaware of any better randomization methods, in fact several groups have proposed improvements, and also demonstrated the benef

Randomization, Masking, and Allocation Concealment is indispensable for any trial researcher who wants to use state of the art randomization methods, and also wants to be able to describe these methods correctly.

Far too often the subtle nuances that distinguish proper randomization from flawed randomization are completely ignored in trial reports that state only that randomization was used, with no additional information. Experience has shown that in many cases, the type of randomization that was used was flawed. It is only a matter of time before medical journals and regulatory agencies come to realize that we can no longer rely on (or publish) flawed trials, and that flawed randomization in and of itself disqualifies a trial from being robust or high quality, even if that trial is of high quality otherwise.

This book will help to clarify the role randomization plays in ensuring internal validity, and in drawing valid inferences from the data. The various chapters cover a variety of randomization methods, and are not limited to the most common (and most flawed) ones. Readers will come away with a profound understanding of what constitutes a valid randomization procedure, so that they can distinguish the valid from the flawed among not only existing methods but also methods yet to be developed.