* This course has been cancelled - please register your interest for 2021*
This course gives attendees a clear understanding of the fundamental principles of Randomised Clinical Trials (RCTs).
Lectures and practical sessions cover the key issues in design, conduct, analysis and reporting, with a focus on major clinical trials that directly influence clinical practice. Topics are addressed with perspectives from both public sector research and the pharmaceutical industry.
Who should attend?
The course is relevant to anyone who'd like to get an understanding of the rigorous evaluation of interventions in health care, including clinical research professionals, research managers, and other scientists with an interest in clinical trials.
The course fee for 2020 is £1,873.50. Fees cover participation in the course, course materials, plus lunch and tea/coffee each day. Fees do not cover travel costs or accommodation.
The course has been approved by the Federation of the Royal Colleges of Physicians of the United Kingdom for 30 category 1 (external) CPD credit(s).
The course will be coordinated by Jennifer Nicholas, Tim Collier and members of the Department of Medical Statistics who have extensive experience in the design, conduct and analysis of trials in a variety of clinical specialities.
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.
For further information about the general structure of the week, please view the Clinical Trials programme.
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.
Comments by course participants
'In my opinion it was very well structured and nicely tailored to its wide range of professionals attending the course'.
'The knowledge of the speakers was very good. You could see that most of them had real experience in the areas of these topics, which is good from a learning perspective'.
'There were opportunities to discuss ideas with peers'.
'GCP was enjoyable and useful and good to get certificate'.
‘The organisation was perfect and the interaction with the lecturers was fantastic.’
‘ Practical sessions were very helpful and allowed the theory to become more understandable.’
‘ Broad range of topics were covered – case studies are brilliant tools to consolidate knowledge.'
‘ I enjoyed study design, data monitoring and the designing protocol and practical sessions. I do like data monitoring a lot and also liked the randomisation session’.
The student is responsible for obtaining any visa or other permissions to attend the course, and is encouraged to start the application process as early as possible as obtaining a visa for the UK can sometimes take a long time. The Short Courses team can provide supporting documentation if requested.
Accommodation and meals
A list of hotels located in the vicinity of LSHTM, along with further resources for short term accommodation, can be found on our accommodation pages. Tea and coffee will be provided during breaks. Lunch vouchers for the LSHTM canteen will also be available.
Evening meals are not catered for at LSHTM, however there is a large choice of restaurants, cafés and shops nearby.
- If you have been offered a place on the course you will not be able to register without bringing formal ID (Passport) and without having obtained the correct visa if required.
- It is essential that you read the current visa requirements for short course students.
- LSHTM may cancel courses two weeks before the first day of the course if numbers prove insufficient. In those circumstances, course fees will be refunded.
- LSHTM cannot accept responsibility for accommodation, travel and other losses incurred as a result of the course being cancelled.