Clinical Trials in Psychiatry

by Everitt, Brian S.; Wessely, Simon

• ISBN13: 9780470513026
• ISBN10: 0470513020
• Edition: 2nd
• Format: Hardcover
• Copyright: 2008-03-03
• Publisher: Wiley-Interscience

Summary

At last - a new edition of the highly acclaimed book Clinical Trials in PsychiatryThis book provides a concise but thorough overview of clinical trials in psychiatry, invaluable to those seeking solutions to numerous problems relating to design, methodology and analysis of such trials. Practical examples and applications are used to ground theory whenever possible. The Second Edition includes new information regarding: Recent important psychiatric trials More specific discussion of psychiatry in the USA and the particular problems of trials in the USA, including comments about the FDA (U.S. Food and Drug Administration) An extended chapter on meta-analysis Further discussion of sub-group analysisSpecial features include appendices outlining how to design and report clinical trials, what websites and software programs are appropriate and an extensive reference section.From the reviews of the First Edition:"Everitt & Wessely are to be congratulated on producing an excellent guide to help overcome the snags in clinical trial research. Clearly written and in an engrossing style, the book is likely to become a classic textbook on clinical trials, and not just in psychiatry. The authors' enthusiasm and grasp of clinical trial research make for a gripping and insightful read...it is one of the very best books that has been written on clinical trials." THE BRITISH JOURNAL OF PSYCHIATRY"The experience of both authors in this area gives the book a very pragmatic approach grounded in reality, with theoretical overviews invariably being followed by practical examples and applications... an invaluable companion to anyone involved in, or contemplating undertaking, clinical trials research." PSYCHOLOGICAL MEDICINE

Author Biography

Brian S. Everitt. Professor of Behavioural Statistics, Department of Biostatistics and Computing, Institute of Psychiatry, King’s College, London, UK.

Simon Wessely. Professor of Epidemiological and Liaison Psychiatry Director, King's Centre for Military Health Research, Institute of Psychiatry, King’s College, London, UK; Department of Psychological Medicine, Weston Education Centre, London, UK.

Table of Contents

Preface to the first edition	p. ix
Preface to the second edition	p. xi
Treatments, good, bad or worthless - and how do we tell?	p. 1
Treatments worthless - and worse	p. 1
A brief history of treating the mentally ill	p. 5
Summary	p. 11
The randomized clinical trial	p. 13
Introduction	p. 13
The clinical trial	p. 17
Ethical issues in clinical trials	p. 29
Informed consent	p. 33
Compliance	p. 36
Summary	p. 40
Design issues in clinical trials	p. 43
Introduction	p. 43
Clinical trial designs	p. 44
Methods of randomization	p. 56
Methods of masking treatments	p. 62
The size of a clinical trial	p. 63
Interim analysis	p. 66
Summary	p. 70
Special problems of trials in psychiatry	p. 71
Introduction	p. 71
Explanatory versus pragmatic trials	p. 72
Complex interventions	p. 79
Outcome measures in psychiatry	p. 81
Summary	p. 87
Some statistical issues in the analysis of psychiatric trials	p. 89
Introduction	p. 89
P-values and confidence intervals	p. 90
Using baseline data	p. 91
Longitudinal data	p. 97
Missing values and dropouts in longitudinal data	p. 103
Multiple outcome measures	p. 108
Intention-to-treat	p. 109
Economic evaluation of trials	p. 112
Number needed to treat	p. 116
Summary	p. 116
Analysing data from a psychiatric trial: an example	p. 119
Introduction	p. 119
Beating the Blues	p. 119
Analysis of the post-treatment BDI scores	p. 123
Graphical displays and summary measure analysis of longitudinal data	p. 128
Random effects models for the BtB data	p. 135
The dropout problem in the BtB data	p. 142
Summary	p. 144
Systematic reviews and meta-analysis	p. 145
Introduction	p. 145
Study selection	p. 148
Publication bias	p. 151
The statistics of meta-analysis	p. 153
Some examples of meta-analysis of psychiatric trials	p. 155
Summary	p. 160
RCTs in psychiatry: threats, challenges and the future	p. 163
Introduction	p. 163
Can randomized clinical trials in psychiatry be justified?	p. 164
Are randomized clinical trials really necessary?	p. 169
Conflicts of interest	p. 170
Scandals, trials and tribulations	p. 171
The future of psychiatric trials	p. 173
Defending the clinical trial	p. 178
Summary	p. 179
Issues in the management of clinical trials - 'how to do it'	p. 181
Introduction	p. 181
Clinical trial protocols	p. 182
Getting the costs right	p. 185
Collecting and managing the data	p. 186
Writing the patient information sheet	p. 188
Getting informed consent	p. 189
Maintaining recruitment	p. 190
Doing the follow-up	p. 191
Useful web sites	p. 191
Writing a trial report	p. 195
Introduction	p. 195
Useful software for clinical trials	p. 201
Introduction	p. 201
Data management	p. 201
Design	p. 202
Analysis	p. 202
Bibliography	p. 205
Index	p. 223
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