This topic has come up in Question 8(p.2) from the first paper of 2008 and the identical Question 6 from the first paper of 2014. These SAQs are duplicates of question b(5) from the 2004 ANZCA primary. In 2014 the examiner's comments were basically just a series of complaints about the poor quality of candidate ("just can't get good candidates these days"). Fortunately, in 2008 the college offered some guidance as to what was expected.
The candidates would have scored highly by discussing the following issues:
- Treatment allocation
- Randomisation to eliminate selection bias
- Adequate sample size to achieve power
- Logistics of conducting multi-centre trials
- Prospective design
- Trials of efficacy versus effectiveness
- Ethical considerations
- The need for “equipoise” as pre-requisite for randomisation
- effects of trial design on avoiding Type I and Type II errors
The LITFL page on randomised controlled trials is an excellent breakdown of what would be relevant to a good detailed answer. Their lists of "strengths" and "weaknesses" could be reproduced by the candidate within the timeframe of a single SAQ, and would offer a good chance of a very high mark. This chapter is in essence a series of footnotes to that LITFL article.
So, in brief exam-oriented summary:
Advantages of randomised control trial study design:
|Disadvantages of randomised control trial study design
The best non-LITFL resources for this sort of thing mainly come from LITFL anyway, and consist of the references offered by Chris Nickson at the end of his article.