Increasingly, researchers are faced with situations where patients may not gain benefits in terms of traditional end points, such as survival or disease-free survival. However, it is possible to see significant changes in health-related quality of life (HRQOL).
HRQOL, a multidimensional construct and an important concept, has, for many years, proven difficult to define. A number of definitions proposed by various authors as to the exact nature of HRQOL and the formulation of a defining consensus are shown in the bottom of the website’s home page.
Generally, HRQOL covers the subjective perceptions of the positive and negative aspects of cancer patients’ symptoms, including physical, emotional, social, and cognitive functions and, importantly, disease symptoms and side effects of treatment.
The U.S. Food and Drug Administration and European Medicines Agency (EMEA) now recognizes the benefits of HRQOL as a basis for approval of new anticancer drugs, and many international research groups include HRQOL in their studies. Nowadays its very common to see overall that most clinical trials include HROQOL as a standard secondary endpoint.