Clinical Trials in Psychiatry, 2nd Edition

by Brian S. Everitt (Institute of Psychiatry, King?s College, London, UK); Simon Wessely (Institute of Psychiatry, King?s College, London, UK)

• ISBN13: 9780470723845
• ISBN10: 047072384X
• Format: eBook
• Copyright: 2008-06-01
• 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

Table of Contents

Preface to the first edition.

Preface to the second edition.

Treatments, good, bad or worthless - and how do we tell?

Treatments worthless - and worse

A brief history of treating the mentally ill

Summary

The randomized clinical trial.

Introduction

The clinical trial

Ethical issues in clinical trials

Informed consent

Compliance

Summary

Design issues in clinical trials.

Introduction

Clinical trial designs

Methods of randomization

Methods of masking treatments

The size of a clinical trial

Interim analysis

Summary

Special problems of trials in psychiatry.

Introduction

Explanatory versus pragmatic trials

Complex interventions

Outcome measures in psychiatry

Summary

Some statistical issues in the analysis of psychiatric trials.

Introduction

P-values and confidence intervals

Using baseline data

Longitudinal data

Missing values and dropouts in longitudinal data

Multiple outcome measures

Intention-to-treat

Economic evaluation of trials

Number needed to treat

Analysing data from a psychiatric trial: an example.

Introduction

Beating the Blues

Analysis of the post-treatment BDI scores

Graphical displays and summary measure analysis of longitudinal data

Random effects models for the BtB data

The dropout problem in the BtB data

Summary

Systematic reviews and meta-analysis.

Introduction

Study selection

Publication bias

The statistics of meta-analysis

Some examples of meta-analysis of psychiatric trials

Summary

RCTs in psychiatry: threats, challenges and the future.

Introduction

Can randomized clinical trials in psychiatry be justified?

Are randomized clinical trials really necessary?

Conflicts of interest

Scandals, trials and tribulations

The future of psychiatric trials

Defending the clinical trial

Summary

Issues in the management of clinical trials- 'how to do it'.

Introduction

Clinical trial protocols

Getting the costs right

Collecting and managing the data

Writing the patient information sheet

Getting informed consent

Maintaining recruitment

Useful web sites

Writing a trial report.

Introduction

Useful software for clinical trials.

Introduction

Data management

Design

Analysis

Bibliography.

Index.

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