Design, Trials and Statistics Books

This page contains a summary of recent books by staff in the Design, Trials and Statistics section of the School of Health and Related Research.  Click on a title or cover to visit the publishers webpage and click on the author to view their profile.

howtodesignHow to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research

Michael J Campbell and Stephen J Walters (Wiley, 2014)

A complete guide to understanding cluster randomised trials Written by two researchers with extensive experience in the field, this book presents a complete guide to the design, analysis and reporting of cluster randomised trials.

"Overall, the reviewers are enthusiastic about the book. The authors have covered all important areas of cRCTs, using a practical and pragmatic approach to the topic. The code is helpful for the practical implementation of the examples. The material is simple to understand, which will appeal to applied researchers, not only to biostatisticians. As such, we clearly recommend this book to all researchers interested in cRCTs. For biostatisticians involved in cRCTs and investigators of cRCTs, it is a must-have on the bookshelf." ("Biometrical Journal," 1 May 2015)


understandingphysioUnderstanding Physiotherapy Research    

Chris Littlewood and Stephen May (Cambridge Scholars Publishing, 2013)

Understanding Physiotherapy Research by Littlewood and May is an introductory level text that aims to be accessible and understandable to all physiotherapists who appreciate the need to integrate research evidence into their practice. The requirement for physiotherapists to engage with evidence-based practice has never been more apparent and the benefits of such an approach are clear. Evidence derived from research is a cornerstone of evidence-based practice, but before such evidence can be incorporated into an evidence-based paradigm, it should be appraised and its trustworthiness and applicability considered. This means that evidence-based physiotherapy practitioners need to be aware of the inherent strengths and limitations of research studies and what these mean for their practice. However, this is not always a straightforward process and it is not uncommon for both novice and experienced physiotherapists to become lost in the language of research. To facilitate the evolution of evidence-based physiotherapy practice, this book aims to bridge the gap by presenting a clinically focused range of methodological discussions in relation to specific research study designs in physiotherapy. The intention of the book is to offer a platform upon which readers can develop their understanding of meaningful critical appraisal and consequently gain confidence when reading published research.

"The authors should be congratulated on writing this book that both enthuses and informs the reader, a book filled with research examples directly relevant to physiotherapy, a book written in refreshingly plain English . . . I strongly recommend this book for physiotherapists in all settings and stages of their careers.”
– Associate Professor Ken Chance-Larsen, Central Queensland University, Australia

systematicapproachSystematic Approaches to a Successful Literature Review

Andrew Booth, Diana Papaioannou and Anthea Sutton (SAGE Publishing, 2012)

Reviewing the literature is an essential part of every research project. This book takes you step-by-step through the process of approaching your literature review systematically, applying systematic principles to a wide range of literature review types. Through numerous examples, case studies and exercises, the book covers often neglected areas of literature review such as concept analysis, scoping and mapping.
The book includes practical tools for supporting the various stages of the review process, including;
- managing your literature review
- searching the literature
- assessing the quality of the literature
- synthesising qualitative and/or quantitative data
- writing up and presenting data
Systematic Approaches to a Successful Literature Review is essential reading for any student or researcher looking to approach their literature review in a systematic way.

"This new interdisciplinary book on preparing and using systematic reviews is the single-best resource on the topic I have encountered. It is exceptionally comprehensive, yet readable and practical. Every human service professional and social scientist who uses the research literature will benefit from reading this great new book. I thoroughly enjoyed reading it and will consult it frequently."
Bruce A. Thyer, Ph.D., LCSW Professor of Social Work, Florida State University


 Genetic EpidemiologyGenetic Epidemiology

Dawn Teare (Humana Press, 2010)

Arising from firm foundations laid by mathematical population genetics, clinical genetics, and statistical epidemiology, genetic epidemiology attempts to identify the many components of risk
attributable to genes, environments, and interactions, and the course of its research can follow many diverse paths. In Genetic Epidemiology, the success of genome-wide association studies in their identification of hundreds of disease susceptibility loci has inspired renowned experts to contribute thorough methodologies, which aim to bring together bioinformaticians, geneticists, clinicians, statisticians, and epidemiologists in the study of this vital field. The volume opens with chapters covering the basics; however, it quickly moves on to coverage of more specialist topics such as twin studies, Mendelian randomization, genetic association studies, more advanced areas, as well as case studies. As a part of the highly successful Methods in Molecular Biology™ series, this work provides the detailed description of the application and analysis of the most commonly employed methods that are necessary for a firm grounding in the field.

Authoritative and cutting-edge, Genetic Epidemiology aims to provide a basic framework for crucial interdisciplinary communication and understanding suited to newcomers to the field as well as experienced researchers and graduate level students.


 An Introduction to Statistics in Early Phase TrialsAn Introduction to Statistics in Early Phase Trials

Steven A Julious, Say-Beng Tan and David Machin (Wiley-Blackwell, 2010)

All new medicines and devices undergo early phase trials to assess, interpret and better understand their efficacy, tolerability and safety. An Introduction to Statistics in Early Phase Trials describes the practical design and analysis of these important early phase clinical trials and provides the crucial statistical basis for their interpretation. It clearly and concisely provides an overview of the most common types of trials undertaken in early phase clinical research and explains the different methodologies used. The impact of statistical technologies on clinical development and the statistical and methodological basis for making clinical and investment decisions are also explained.
• Conveys key ideas in a concise manner understandable by non-statisticians
• Explains how to optimise designs in a constrained or fixed resource setting
• Discusses decision making criteria at the end of Phase II trials
• Highlights practical day-to-day issues and reporting of early phase trials

An Introduction to Statistics in Early Phase Trials is an essential guide for all researchers working in early phase clinical trial development, from clinical pharmacologists and pharmacokineticists through to clinical investigators and medical statisticians. It is also a valuable reference for teachers and students of pharmaceutical medicine learning about the design and analysis of clinical trials.

"An Introduction to Statistics in Early Phase Trials" is an admirably concise and practical guide to the pertinent context, principles and formulae for statisticians inexpert in the application of their discipline to Phase I and II clinical research". (Journal of Clinical Research Best Practices, 1 March 2011)

"An Introduction to Statistics in Early Phase Trials provides concise descriptions of many early phase trial designs, along with the statistical equations necessary to gather and analyze the data." (Annals of Pharmacotherapy, 2010)



SamplesizeSample Sizes for Clinical Trials

Steven A Julious (CRC Press, 2009)

Drawing on various real-world applications, Sample Sizes for Clinical Trials takes readers through the process of calculating sample sizes for many types of clinical trials. It provides descriptions of the calculations with a practical emphasis.
Focusing on normal, binary, ordinal, and survival data, the book explores a range of trials, including superiority, equivalence, non-inferiority, bioequivalence, and precision for both parallel group and crossover designs. The author discusses how trial objectives impact the study design with respect to the derivation of formulae for sample size calculations. He uses real-life studies throughout to show how the concepts and calculations can be employed.
This work underscores the importance of sample size calculation in the design of a clinical trial. With useful calculation tables throughout, it enables readers to quickly find an appropriate formula, formula application, and associated worked example.

Watch the author speak about this book at the JSM conference in San Diego

"… a useful compendium that takes the reader through the process of calculating sample sizes and addresses many points to consider for the most common types of clinical trials and data. … this book provides a good introduction to the most common trial design scenarios for comparing two treatments. With a lot of hints, tips, and numeric examples, it is easy to read for statisticians and non-statisticians."
―ISCB News, December 2015

"… it is lively, peppered with opinions and advice, and full of methods. … the book has many useful formulas for a variety of designs. It is well organized, so users can easily find the section relevant to their needs. And the plethora of worked examples is very helpful. … a useful introduction to the clinical researcher and as a reference for the statistician interested in sample size formulae for specific designs."
―Janet T. Wittes, Biometrics, February 2012