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Although in this chapter we will focus on one particular design, there are many features of the clinical trials process which are common to the majority of situations. Thus, we use the example of a parallel two‐group individually randomised trial to overview some pertinent issues, ranging from defining carefully the research question posed, and thereby the type of subjects to recruit, the interventions used, the allocation of the trial participants to these interventions, endpoint assessment, analysis and reporting. However, in later chapters we will expand on detail and also on other design options.

This basic design will often compare a Test therapy or intervention with a Standard (or control) therapy. Frequently, the patients will be assigned at random to the options on a 1 : 1 basis. In reality, the actual choice of design will be a key issue at the planning stage and it should not be assumed that the common design used here for illustration best suites all purposes.