Introduction to Clinical Trials: the book
An Introduction to Clinical Trials is intended to provide an accessible way to learn about clinical trials for those new to the field and those who work in clinical trials and would like to broaden their understanding.
The book has 10 chapters that cover the history of clinical trials, types of clinical trial types through the set-up, conduct, analysis and sharing findings.
It is published by Oxford University Press (OUP) and is available to purchase online or from all good bookshops. Both paperback and ebook formats (epub and updf) are available.
Table of contentS
- Abbreviations
- Chapter 1 - What is a clinical trial?
- Chapter 2 - Designing a clinical
- Chapter 3 - Randomised controlled trials
- Chapter 4 - Alternative randomised controlled trial designs
- Chapter 5 - Choosing the sample size for a clinical trial
- Chapter 6 - Setting up a clinical trial
- Chapter 7 - Data collection and monitoring in a clinical trial
- Chapter 8 - Conducting a clinical trial
- Chapter 9 - Analysing a clinical trial
- Chapter 10 - Reporting and disseminating the findings of a clinical trial
- Glossary of key terms
Analysis files for download
Download Stata do files to replicate analyses from Chapter 9:
- TOPKAT study (Table 9.1 continuous outcome)
- LEAP study (Table 9.2 binary outcome)
- IST study (Table 9.3 binary/time to event outcome)
ERRATUM
Below is a list of typographical/formatting errors in the book. If you spot one please do let me and I will add to this list.
- Chapter 9, p217: The first sentence should read "The risk is 0.4% higher in the no aspirin group and using Newcombe's method (no. 10) to calculate the 95% confidence interval we see that it goes from -1.2% to 0.4% (i.e. the percentage of death could be 1.2% lower in the aspirin group to 0.4% higher in the no aspirin group)".
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Chapter 9, table 9.3, p217: “Effect measure (95% CI)” results for risk difference analysis should be "-0.4% (-1.2%, 0.4%)".