Essentials of Clinical Trials

The topics to be covered will include:

• Design of RCT: randomisation, blinding, trial size
• Ethical conduct: participant consent, data monitoring and when to stop early
• Certified Good Clinical Practice (GCP) training
• Introduction to statistical methods for both design and analysis
• Alternative designs for clinical trials
• Reporting: how to write, and critique, a clinical trial report
• Clinical trials in practice
• Practical experience in development of a clinical trial protocol. (Participants will work in small groups to develop and present trial protocols.)

Sessions run from 9.30am to 5.00pm each day, finishing early on Friday.

The course will include some lectures, but the main focus will be on participatory practical sessions. All materials required for the course are provided. The following books are recommended as additional background reading:

• Wang D, Bakhai A. Clinical Trials: A Practical Guide to Design, Analysis, and Reporting. ReMEDICA, London, 2007.
• Evans I, Thornton H, Chalmers I. Testing Treatments: Better Research for Better Healthcare. The British Library 2006.
• Flather M, Aston H and Stables R (eds). Handbook of Clinical Trials. ReMEDICA 2001.
• Pocock SJ. Clinical Trials: A Practical Approach. Wiley, Chichester, 1983

There is no formal assessment. At the conclusion of the course, a certificate of attendance will be provided including confirmation of Good Clinical Practice (GCP) training.