The FDA guidance for industry on PROs: the point of view of a pharmaceutical company

被引：0
作者：
Fabio Arpinelli
Francesco Bamfi
机构：
[1] GSK S.p.A.,Health Technology Assessment, Medical Department
来源：
Health and Quality of Life Outcomes | / 4卷
关键词：
Minimal Important Difference; Labelling Claim; Minimal Important Change; Reimbursement List; Domain Questionnaire;
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摘要：
The importance of the patients point of view on their health status is widely recognised. Patient-reported outcomes is a broad term encompassing a large variety of different health data reported by patients, as symptoms, functional status, Quality of Life and Health-Related Quality of Life. Measurements of Health-Related Quality of Life have been developed during many years of researches, and a lot of validated questionnaires exist. However, few attempts have been made to standardise the evaluation of instruments characteristics, no recommendations are made about interpretation on Health-Related Quality of Life results, especially regarding the clinical significance of a change leading a therapeutic approach. Moreover, the true value of Health-Related Quality of Life evaluations in clinical trials has not yet been completely defined. An important step towards a more structured and frequent use of Patient-Reported Outcomes in drug development is represented by the FDA Guidance, issued on February 2006.
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