Health-related quality of life assessment and the pharmaceutical industry.

Concerns about cost containment in healthcare and interest in the impact of medical treatment on patient health status and well-being have increased the emphasis on health-related quality of life (HRQOL) research. HRQOL assessment as part of the development and evaluation of pharmaceuticals is a reality and is likely to increase over time. HRQOL studies may assist industry in the regulatory approval process, for marketing purposes, and to assist physicians and healthcare managers in making decisions about alternative drug therapies. HRQOL studies provide physicians with complete information about the benefits and risks of drug treatments in terms of patient physical, psychological, and social functioning and well-being. HRQOL measures, especially health utility assessments, can contribute to defining health outcomes in cost-effectiveness analyses. HRQOL studies need to be planned early in the drug development process and careful attention must be made to selecting comparative medical treatments, instrumentation, data collection protocols, length of follow-up, and sample size for these studies. It is important to address issues of investigator and other sources of bias. There is evidence that the pharmaceutical industry is increasing the use of HRQOL outcomes in clinical studies. Healthcare decision-makers, physicians and patients are demanding that industry demonstrate the impact of a new drug on patient HRQOL in addition to safety and efficacy. Clearly, HRQOL represents an important indicator of the benefit of pharmaceuticals.