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 the 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 afternoons. Participants will be able to discuss specific questions about their own research with a member of staff from the Medical 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 a combination of live lectures and practical sessions, which can either be attended in person at LSHTM in London or online via video conferencing using Zoom.

Each of the practical sessions is directly related to a lecture, and participants will be expected to attend the live lecture (in person or online) before the related practical. 

Live sessions will run each day of the course, and will take place between approximately 9.30 am and 5 pm British Summer Time (BST) with breaks for drinks and lunch. Participants who are taking part in the course online using Zoom will need to have a reliable internet service and a PC or laptop with microphones and speakers.

A Guest Lecture will be given by an invited speaker.

Course materials

The course materials include lecture videos which will be available to watch for 5 weeks as described above. 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.