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The course introduces the key considerations when designing and conducting a randomised clinical trial.

Throughout the five-day course, delegates will learn why clinical trials are necessary, how different kinds of trials are designed and how bias can be minimised, how trials are managed and then analysed, interpreted and reported.

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 trials, considering both drug and complex intervention trials.

 By the end of the course, 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 of different designs for randomised trials and their use
• be aware what information is required to estimate the size of a trial
• be able to participate in the design of a randomised clinical trial
• understand how an economic evaluation can be embedded into a clinical trial

• understand how using qualitative methodologies can complement a clinical trial
• understand the importance of Patient and Public Involvement (PPI) throughout the lifecycle of a trial
• 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
• know how to report and interpret results from a randomised clinical trial

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.

Exact timings and further details will be provided nearer the time, though days will usually start around 09.00 and end at 16.30.

All sessions on the course will be led by experienced trialists and staff from Nottingham Clinical Trials Unit.