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Overview Overview
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Study design for health-related quality of life assessment Study design for health-related quality of life assessment
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Further reading Further reading
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Cite
Extract
Overview
In the context of drug approval, health-related quality of life (HRQL) is considered to represent a specific type/subset of PROs, distinguished by its multi-dimensionality. Indeed, HRQL is a broad concept which can be defined as the patient's subjective perception of the impact of his disease and its treatment(s) on his daily life, physical, psychological, and social functioning and well-being.
The definition of HRQL has as a common basis the definition of health given by the WHO in 1948 as a state of total physical, mental, and social well-being and not simply the absence of disease.
The basis for the approval of a new medicinal product is its efficacy and safety. Therefore, in the drug evaluation process, the first step is to assess efficacy and safety. However, there is an increasing need to measure the effect of the medicinal product on HRQL. A claim about improvement in HRQL needs to be supported by data collected by instruments validated for use in the corresponding condition. In order to approve a global claim that a product ‘improves HRQL,’ it would be necessary to demonstrate robust improvements in all or most of these domains.
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