ABSTRACT
Development of a priori objectives and an analytic plan are essential to both good trial design and subsequent scientific review. This chapter will focus on design and protocol development, with the exception of the statistical considerations such as sample size and analysis plans (see Chapter 12). Table 2.1 is a checklist for protocol development. All principles of good clinical trial methodology are applicable [49, 53, 99, 113, 141], but there are additional requirements specific to HRQoL. These include selection of an appropriate measure of HRQoL and the conduct of the assessment to minimize any bias. Because of the multidimensional nature of HRQoL and repeated assessments over time, objectives need to be explicitly specified and a strategy developed for handling multiple endpoints.
