This 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 analysis
Special 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
Preface to the second edition.
1. Treatments, good, bad or worthless and how do we tell?
1.1 Treatments worthless and worse.
1.2 A brief history of treating the mentally ill.
2. The randomized clinical trial.
2.2 The clinical trial.
2.3 Ethical issues in clinical trials.
2.4 Informed consent.
3. Design issues in clinical trials.
3.2 Clinical trial designs.
3.3 Methods of randomization.
3.4 Methods of masking treatments.
3.5 The size of a clinical trial.
3.6 Interim analysis.
4. Special problems of trials in psychiatry.
4.2 Explanatory versus pragmatic trials.
4.3 Complex interventions.
4.4 Outcome measures in psychiatry.
5. Some statistical issues in the analysis of psychiatric trials.
5.2 P–values and confidence intervals.
5.3 Using baseline data.
5.4 Longitudinal data.
5.5 Missing values and dropouts in longitudinal data.
5.6 Multiple outcome measures.
5.8 Economic evaluation of trials.
5.9 Number needed to treat.
6. Analysing data from a psychiatric trial: an example.
6.2 Beating the Blues.
6.3 Analysis of the post–treatment BDI scores.
6.4 Graphical displays and summary measure analysis of longitudinal data.
6.5 Random effects models for the BtB data.
6.6 The dropout problem in the BtB data.
7. Systematic reviews and meta–analysis.
7.2 Study selection.
7.3 Publication bias.
7.4 The statistics of meta–analysis.
7.5 Some examples of meta–analysis of psychiatric trials.
8. RCTs in psychiatry: threats, challenges and the future.
8.2 Can randomized clinical trials in psychiatry be justified?
8.3 Are randomized clinical trials really necessary?
8.4 Conflicts of interest.
8.5 Scandals, trials and tribulations.
8.6 The future of psychiatric trials.
8.7 Defending the clinical trial.
Appendix A. Issues in the management of clinical trials– ′how to do it′.
A.2 Clinical trial protocols.
A.3 Getting the costs right.
A.4 Collecting and managing the data.
A.5 Writing the patient information sheet.
A.6 Getting informed consent.
A.7 Maintaining recruitment.
A.8 Useful web sites.
Appendix B. Writing a trial report.
Appendix C. Useful software for clinical trials.
C.2 Data management.