Module 1 will discuss why clinical trials are necessary, how different kinds of trials are designed and how bias can be minimised, and how trials are analysed, interpreted and reported. Module 2 will consider the conduct and management of both drug and complex intervention trials.
The course will not consider non-randomised trials or other observational designs, or trials evaluating diagnostic tests. We will primarily focus on large multi-centre clinical trials, particularly during Module 2.
You can choose to attend just one module or both. If you wish to attend Module 2 only, you will need to have an understanding of trial design to the level that is covered during Module 1.
By the end of Module 1 - trial design, participants should:
· understand when and why randomised controlled trials are necessary
· understand and evaluate methods to minimise bias in the design and conduct of randomised controlled trials
· be aware what information is required in order to estimate the size of a trial and of appropriate statistical methods to analyse the data
· be able to participate in the design of a randomised clinical trial
· know how to report a clinical trial
By the end of Module 2 - trial management, participants should:
· understand when and which approvals and regulations are needed in clinical trials
· have an understanding of a clinical trial protocol and other trial documentation
· have an understanding of factors to consider when undertaking a multi-centre clinical trial
· be aware of trial safety and requirements for clinical trials involving medicinal products
· have an understanding of risk assessment, data collection and monitoring of trial data
The course is intended for anyone seeking an introductory course on randomised controlled trials, and who is likely to be involved in the design, conduct and management, analysis, reporting or review of clinical trials. The course will comprise of lectures, workshops and discussion.
£800 for all 5 days (Module 1 and 2)
£480 for Module 1
£320 for Module 2
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