Discuss the stages in designing a clinical trial.
An outline of the background literature review, defining the hypothesis, study design, ethics, funding, consent, conduct and follow-up was expected. Common omissions related to details on study design e.g. minimising bias and error. Some candidates misinterpreted the question as phases of clinical research (0-IV).
From the inclusion of this topic in the primary curriculum, one might think that the college expects their fellows to be competent in running and designing a clinical trial.
In brief summary, the stages of clinical trial design are as follows:
This is all as seen in LITFL. Much more detail can be seen in Myles and Gin (pp.135-145), in the section titled "How to design a clinical trial". Locally, an extensive rant-form "summary" is also available.
Statistical methods for anaesthesia and intensive care (P S Myles, T Gin - 1st ed - Oxford : Butterworth-Heinemann, 2001)
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