Clinical Trials

We are still accepting applications for this course

Course outline

Clinicians, policy makers and patients are increasingly demanding high quality evidence to help with making decisions about health care. There is a hierarchy of such evidence ranging from anecdote and observational studies up to randomised controlled trials (RCTs). In these trials, the effects of different treatments or other interventions are compared to each other by giving the treatments to patients 'at random', thus providing a 'fair' and unbiased comparison. RCTs provide much of the evidence needed to register new drugs for use, but trials are also used for comparing a wide range of non-drug treatments, such as medical versus surgical managements for cancer. This course will provide an introduction to the area of clinical trials, particularly phase III trials, with more detailed coverage of some of the key issues to be considered in their design, analysis and interpretation.

Teaching

The course will be led by Professor Diana Elbourne, Professor Stuart Pocock, Tim Clayton and other members of the Medical Statistics Unit who have extensive experience in the design, conduct and analysis of trials in a variety of clinical specialities.

Course Content

The topics to be covered will include:

o Essentials of RCTs and ethical issues
o Introductory statistics for design, analysis and reporting
o Design - randomisation, trial size, data monitoring, and 'alternative' designs
o Analysis and reporting
o Systematic reviews and meta-analyses of trials.
o Development of a protocol. (Participants will work in small groups to develop and present trial protocols.)

Sessions run from 9.30am to 5.00pm each day.

There will be no formal examination. A Certificate of Attendance will be awarded to all completing the course.

Course Materials

The course will include some lectures, but the main focus will be on participatory practical sessions. A course manual will be given to the participants at the beginning of the week. The following books are recommended, and will be available at reduced rates during the course:

o Wang D, Bakhai A. Clinical Trials: A Practical Guide to Design, Analysis, and Reporting. ReMEDICA, London, 2007.

o Evans I, Thornton H, Chalmers I. Testing Treatments: Better Research for Better Healthcare. The British Library 2006.

o Flather M, Aston H and Stables R (eds). Handbook of Clinical Trials. ReMEDICA 2001.

o Matthews JNS. An Introduction to Randomized Controlled Clinical Trials. Arnold, London. 2000

o Pocock SJ. Clinical Trials: A Practical Approach. Wiley, Chichester, 1983

Methods of assessment

There is no formal assessment but at the conclusion of the course, a certificate of attendance will be provided.

Who should apply for this course?

The course is relevant to all those with an interest in the rigorous evaluation of interventions in health care, particularly clinicians and others working or intending to work in the health services or related areas such as the pharmaceutical industry.

Accommodation

The School cannot provide accommodation for participants. A list of hotels and other accommodation located in the vicinity of the School can be supplied on request to the Registry.

The London School of Hygiene & Tropical Medicine is committed to improve global health through its programme of short and full-time postgraduate study.

Please return a completed application form along with an equal opportunities form to:

Registry, LSHTM, 50 Bedford Square, London WC1B 3DP, UK, Tel: +44 (0)20 7299 4648

Alternatively, by fax:

Fax: +44 (0)20 7323 0638

Or email: shortcourses@lshtm.ac.uk