Brian S. Everitt & Simon Wessely 
Clinical Trials in Psychiatry 

At last – a new edition of the highly acclaimed book
Clinical Trials in Psychiatry

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

Mục lục

Preface to the first edition.

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.

1.3 Summary.

2. The randomized clinical trial.

2.1 Introduction.

2.2 The clinical trial.

2.3 Ethical issues in clinical trials.

2.4 Informed consent.

2.5 Compliance.

2.6 Summary.

3. Design issues in clinical trials.

3.1 Introduction.

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.

3.7 Summary.

4. Special problems of trials in psychiatry.

4.1 Introduction.

4.2 Explanatory versus pragmatic trials.

4.3 Complex interventions.

4.4 Outcome measures in psychiatry.

4.5 Summary.

5. Some statistical issues in the analysis of psychiatric
trials.

5.1 Introduction.

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.

5.7 Intention-to-treat.

5.8 Economic evaluation of trials.

5.9 Number needed to treat.

6. Analysing data from a psychiatric trial: an
example.

6.1 Introduction.

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 Bt B data.

6.6 The dropout problem in the Bt B data.

6.7 Summary.

7. Systematic reviews and meta-analysis.

7.1 Introduction.

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.

7.6 Summary.

8. RCTs in psychiatry: threats, challenges and the
future.

8.1 Introduction.

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.

8.8 Summary.

Appendix A. Issues in the management of clinical
trials- ‘how to do it’.

A.1 Introduction.

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.

B.1 Introduction.

Appendix C. Useful software for clinical trials.

C.1 Introduction.

C.2 Data management.

C.3Design.

C.4 Analysis.

Bibliography.

Index.

Giới thiệu về tác giả

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.