Abstract
Effect' is associated with any primary trial endpoint, such as death, occurrence or recurrence of a disorder or measure of symptoms. Equivalence and non-inferiority trials are conducted when the new intervention is expected to have fewer side effects, be more cost-effective, have improved quality of life or be more convenient to administer or appealing. A randomised controlled phase III trial should provide enough evidence to warrant a change in practice. Key design features were outlined in Chapter 1 which are covered in more detail here. This chapter provides an overview of the main types of objectives, common designs, specific considerations of the main design components (population, intervention, control and outcome: PICO), non-inferiority and multiplicity. In addition to specific references for this chapter, several more are given on page 205 (further reading).
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