ABSTRACT
Randomised controlled trials (RCTs) are carried out to compare the effectiveness of a specific treatment against one or more others.
This Chapter explains the design of these studies, along with issues such as random allocation, placebos, blinding and double blinding plus cross-over and multi-centre designs.
Recruitment of subjects, data collection, data analysis (including intention to treat analysis) and reporting are also specifically discussed.
The importance of good ethical practice is also highlighted and discussed.
Some advantages and disadvantages of randomised controlled trials are presented and compared.
