This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.

Evidence from randomized controlled clinical trials is widely accepted as the only sound basis for assessing the efficacy of new medical treatments. Statistical methods play a key role in all stages of these trials, including their justification, design, and analysis. This second edition of Introduction to Randomized Controlled Clinical Trials prov

Praise for the First Edition “All medical statisticians involved in clinical trials should read this book...” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley.

Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, the book covers basic concepts underlying the use of cluster randomisation, such as direct, indirect, and total effects. In the time since the publication of the first edition, the use of cluster randomised trials (CRTs) has increased substantially, which is reflected in the updates to this edition. There are greatly expanded sections on randomisation, sample size estimation, and alternative designs, including new material on stepped wedge designs. There is a new section on handling ordinal outcome data, and an appendix with descriptions and/or generating code of the example data sets. Although the book mainly focuses on medical and public health applications, it shows that the rigorous evidence of intervention effects provided by CRTs has the potential to inform public policy in a wide range of other areas. The book encourages readers to apply the methods to their own trials, reproduce the analyses presented, and explore alternative approaches.

Cluster randomised trials are trials in which groups (or clusters) of individuals are randomly allocated to different forms of treatment. In health care, these trials often compare different ways of managing a disease or promoting healthy living, in contrast to conventional randomised trials which randomise individuals to different treatments, classically comparing new drugs with a placebo. They are increasingly common in health services research. This book addresses the statistical, practical, and ethical issues arising from allocating groups of individuals, or clusters, to different interventions. Key features: Guides readers through the stages of conducting a trial, from recruitment to reporting. Presents a wide range of examples with particular emphasis on trials in health services research and primary care, with both principles and techniques explained. Topics are specifically presented in the order in which investigators think about issues when they are designing a trial. Combines information on the latest developments in the field together with a practical guide to the design and implementation of cluster randomised trials. Explains principles and techniques through numerous examples including many from the authors own experience. Includes a wide range of references for those who wish to read further. This book is intended as a practical guide, written for researchers from the health professions including doctors, psychologists, and allied health professionals, as well as statisticians involved in the design, execution, analysis and reporting of cluster randomised trials. Those with a more general interest will find the plentiful examples illuminating.

The phrase "evidence-based policy" is frequently used, but it's crucial that such claims are scrutinized and validated. When the data on social and behavioral interventions are presented, high-quality evidence must be clearly defined and the methodology behind such studies held to rigorous standards. Both the Cochrane Collaboration –focusing on healthcare – and the international Campbell Collaboration – concentrating on criminal justice, education, and social services – were created to develop, maintain and improve detailed guidelines for producing high-quality systematic reviews. And both organizations emphasize randomized controlled trials to evaluate the effectiveness of various interventions. As a springboard from the Campbell Collaboration initiative and supported by the Rockefeller Foundation, this special issue of The Annals includes a thorough review of randomized tests across a variety of studies. Exploring significant dimensions of place randomized trials (also called cluster randomized trials or group randomized trials), these papers shed light on recent efforts to enhance the quality of designing such trials as well as on results reporting. The research topics included in this volume are diverse. Taken together, these papers offer important insight into the nuts and bolts of conducting randomized trials: the significance of place in trials; how such studies are initiated; the incentives and justifications needed by participants; how to overcome challenges of implementation; and where to find out what studies have already been conducted or are currently underway. While providing far-reaching insight into the topic of randomized testing, these papers also identify new issues and key questions to be further addressed in future research. Scholars and policymakers alike will find this collection of rigorous research essential in understanding the implications of current evidence-based policies as well as a guidepost for designing and conducting new studies.

Randomized controlled trials are one of the most powerful and revolutionary tools of research. This book is a convenient and accessible description of the underlying principles and practice of randomized controlled trials and their role in clinical decision-making. Structured in a jargon-free question-and-answer format, each chapter provides concise and understandable information on a different aspect of randomized controlled trials, from the basics of trial design and terminology to the interpretation of results and their use in driving evidence-based medicine. The authors end each chapter with their musings, going beyond the evidence or citations, and sometimes even beyond orthodox correctness to share their thoughts and concerns about different aspects of randomized controlled trials, and their role within the health system. Updated to include insights from the last decade, this second edition challenges over-reliance on randomized controlled trials by debating their strengths and limitations and discussing their optimal use in modern healthcare. It also includes a new and increasingly relevant chapter on the ethics of randomized trials. World renowned writers and thinkers Drs Jadad and Enkin bring you this invaluable book for busy health professionals who wish to understand the theory of randomized controlled trials and their influence on clinical, research or policy decisions.