ABSTRACT
Traditionally, clinical trials have focused on endpoints that are physical or laboratory measures of response. Therapies for cancer are typically evaluated on the basis of disease progression and survival. Although traditional biomedical measures are often the primary endpoints in clinical trials, they do not reflect how the patient feels and functions in daily activities. Yet these perceptions reflect whether or not the patient believes he or she has benefited from the treatment. The patient’s perception of his or her well-being may be the most important health outcome [41]. More recently, clinical trials have included endpoints that reflect the patient’s perception of his or her well-being and satisfaction with therapy. The term Quality of Life (QOL) is used in a variety of ways. In this chapter, I will use it as a surrogate for measures of healthrelated quality-of-life (HRQoL) as well as other patient reported outcomes such as health status and symptoms.
