This course will take place at the MRC Unit in The Gambia at LSHTM.
This course gives attendees a clear understanding of the fundamental principles of Randomised Clinical Trials (RCTs).
Live lectures and practical sessions will 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, statisticians and other scientists with an interest in clinical trials.
Teaching
The course in The Gambia is coordinated by Nuredin Mohammed, Armel Zemsi and Tim Collier in London. The course will include lectures from experienced teachers from both London and The Gambia, with long term practice in the design, conduct and analysis of trials in a variety of clinical specialities in high, middle- and low-income countries. Lecture will be accompanied by a practical sessions in which the concepts taught in the lecture will be applied to practical exercises.
Course fee
The course fee for 2023 is £1,750.
The fee includes all teaching and practical materials (in electronic and paper format if needed), temporary Stata license, use of computer equipment, vouchers for daily lunch and refreshments, welcome and farewell social outings to explore a bit of The Gambia (aka “The Smiling Coast”). Childcare is available upon request. Fee excludes accommodation, breakfast and dinner, flights, visa, and local transport.
Scholarship
A limited number of scholarships will be available for candidates from Sub-Saharan African (SSA) countries based on need for support and potential to apply the skills learned from the course. This should be clearly explained in the personal statement on the application form and must be supported by a letter from the candidate’s line manager/supervisor. The support letter from the line manager/supervisor must be uploaded at the end of the application form under ‘evidence of sponsorship’.
Studying at the MRC Unit in Fajara
The Unit offers a wide range of services including comfortable accommodation, inexpensive food options (including vegetarian), on-site clinical services on site, 24/7 WIFI and 24/7 electricity, on-site daily sports activities on site, nearby pool/gym, tennis options etc.
Last but not least, the beach is situated just 200m away from the campus. Previously, the course organised several evening sessions such as “Meet the Professors” where students could discuss their research projects individually with selected lecturers while enjoying the sunset.
Course content
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 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.) - Guest lecture
In addition to the formal teaching sessions, we will run two optional drop-in sessions on Wednesday and Thursday afternoon. Participants will be able to discuss specific questions about their own research with a member of staff from the Statistics Department or the Clinical Trials Unit. We will provide forms for you to submit your questions ahead of the drop-in sessions.
Teaching format
Teaching will take place through live lectures and practical sessions, which should be attended in person at MRCG at LSHTM in The Gambia.
Each of the practical sessions is directly related to a lecture, and participants will be expected to attend the live lecture before the related practical.
A Guest Lecture will be given by an invited speaker either in person or online.
Course materials
Lecture notes and slides and practical handouts will be available to download and keep. All materials required for the course will be provided in advance. Practical solutions will be provided at the end of each practical.
The following are recommended as optional additional background materials:
- Evans I, Thornton H, Chalmers I and Glasziou P. Testing Treatments: Better Research for Better Healthcare. Pinter and Martin, 2011.
- Friedman LM, Furberg CD, DeMets D, Reboussin DM, and Granger CB. Fundamentals of Clinical Trials. Springer, 2015
- Pocock SJ. Clinical Trials: A Practical Approach. Wiley, 1983
Assessment
There is no formal assessment.
Comments by course participants (from the London course)
'Having the lectures online so you can watch (and re-watch) is really helpful and keeping the content available for a couple of weeks is great.'
'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’.
How to apply
Applications are now closed. You can register your interest and we will let you know when applications reopen.
Please read LSHTM's Admissions policies prior to submitting your application.
Accommodation and meals
Registered students will be offered safe arrangements for accommodation and meals for the duration of their stay in The Gambia. The course fee only includes the provision of lunch and snacks. Further details on accommodation options will be made available at a later stage to registered participants.
Important information
Please note:
- 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.
- 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.