Recommendations on health-related quality of life research to support labeling and promotional claims in the United States

Health-related quality of life (HRQL) outcomes evaluation is becoming an im portant component of clinical trials of new pharmaceuticals and medical dev ices. HRQL research provides patients, providers, and decision makers with important information on the impact of disease and treatment on physical, p sychological, and social functioning and well-being. These outcomes are als o useful to the pharmaceutical and device industries as they attempt to und erstand and communicate product value to physicians, patients, health insur ers and others. HRQL labeling and promotional claims in the US are likely t o increase over the next few years. The evidentiary requirements to make su ch a claim should be based on accepted scientific standards of HRQL evaluat ion and consistent with the regulatory requirements for clinical efficacy. This report outlines the scientific practices that should be considered in the evaluation of evidence for an HRQL claim, including the selection of ap propriate domains, evidence to support the reliability and validity of HRQL measurement, considerations in research design and statistical analyses, a nd the issue of clinical significance. Representatives from the pharmaceuti cal and device industries, regulatory agencies, and the HRQL scientific com munity should work together to make certain the use of HRQL in labeling and promotion are based on sound scientific evidence, and that these messages are clearly and accurately reported to the consumers.