Regulatory aspects on quality of life measurements

Abstract

Quality of life measurements have become important in clinical drug trials together with the traditional outcomes efficacy and safety. Several problems arise when evaluating such data in the process of licensing a drug or in approving a clinical trial. Instruments for quality of life measurements must have sufficient reliability and validity. The sensitivity of the method – that is, the capacity to differentiate between therapies – should have been tested. The interpretation of reported results raises several problems. How should one consider the multitude of subjective experiences and expectations that are important to people's life and cultural relationships? This is particularly relevant when a study is international and when the results are submitted in a country different from where it was performed. The results of quality of life measurements seem to be closely related to the effectiveness or adverse reactions of the treatment. Further research and discussion are needed to evaluate the contribution of quality of life measurements in the process of approving drugs. These data may be especially important when instituting prophylactic or palliative treatments.