Second edition
by Brian S. Everitt
Clinical Trials in Psychiatry 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.
Clinical Trials in Psychiatry includes:
- 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
Contents
1. Treatments, good, bad or worthless – and how do we tell
- Treatments worthless – and worse
- A brief history of treating the mentally ill
2. The randomized clinical trial
- The clinical trial
- Ethical issues in clinical trials
- Informed consent
- Compliance
3. Design issues in clinical trials
- Clinical trial designs
- Methods of randomization
- Methods of masking treatments
- The size of a clinical trial
- Interim analysis
4. Special problems of trials in psychiatry
- Explanatory versus pragmatic trials
- Complex interventions
- Outcome measures in psychiatry
5. Some statistical issues in the analysis of psychiatric trials
- 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
6. Analysing data from a psychiatric trial: an example
- 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
7. Systematic reviews and meta-analysis
- Study selection
- Publication bias
- The statistics of meta-analysis
- Some examples of meta-analysis of psychiatric trials
8. RCTs in psychiatry: threats, challenges and the future
- 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
Index
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