Randomization, Masking, and Allocation Concealment: 1st Edition (Hardback) book cover

Randomization, Masking, and Allocation Concealment

1st Edition

Edited by Vance Berger

Chapman and Hall/CRC

251 pages | 30 B/W Illus.

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Hardback: 9781138033641
pub: 2017-10-26
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pub: 2017-10-30
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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.

Table of Contents

Randomization and Bias in Historical Perspective

J. Rosser Matthews

Proper Randomization Reduces the Chance of Waste Biomedical Research

Arturo Martí-Carvajal

Sympathetic bias: a Neglected Source of Selection Bias

William C. Grant

The Alleged Benefits of Unrestricted Randomization

Vance W. Berger

Restricted Randomization: Pros and Cautions

Jonathan Chipman

Evolution of Restricted Randomization with Maximum Tolerated Imbalance

Wenle Zhao

Evaluating the Evaluation

Adriana C. Burgos, Ross J. Kusmick

Selection Bias in Studies with Unequal Allocation

Olga M. Kuznetsova

Unrecognized Dual Threats to Internal Validity Relating to Randomization

Vance W. Berger, Adriana C. Burgos, Omolola A. Odejimi

Testing for second-order selection bias effect in randomised control trials using reverse propensity score (RPS)

Steffen Mickenautsch, Bo Fu

The Berger-Exner Test to Detect Third Order Selection Bias in the Presence of a True Treatment Effect

Steffen Mickenautsch, Bo Fu, Vance W. Berger

Adjusting for and detection of selection bias in randomized controlled clinical trials

Lieven N. Kennes

Randomization and the randomization test: Two sides of the same coin

Patrick Onghena

Randomization tests or permutation tests? A historical and terminological clarification

Patrick Onghena

Flexible Minimization: Synergistic Solution for Selection Bias

Donald R. Taves

About the Editor

Vance W. Berger received holds a doctoral degree in Statistics from Rutgers University. His professional career has included work in the pharmaceutical industry (Janssen Research Foundation, Theradex, and some consulting for Pfizer), work in two centers of the Food and Drug Administration (Drugs and Biologics), and review work for a number of statistical and medical journals. An active researcher, Dr. Berger wrote a book on the design and analysis of randomized clinical trials (focusing on randomization methods). He has also authored numerous book chapters and scientific articles appearing in the peer-reviewed literature, and has presented numerous invited lectures on this topic. Dr. Berger was the recipient of the 2006 Gertrude Cox Award, recognizing "a statistician making significant contributions to statistical practice" by the Washington Statistical Society.

About the Series

Chapman & Hall/CRC Biostatistics Series

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Subject Categories

BISAC Subject Codes/Headings:
MATHEMATICS / Probability & Statistics / General
MEDICAL / Biostatistics