Quality of life and regulatory issues.
Since Quality of Life is increasingly more often used as a therapeutic endpoint in clinical trials, it is essential that the same level of scientific rigour is applied to these assessments. The draft guidelines issued by the Food and Drug Administration as well as with the Common Market are therefore welcomed.
Wiklund
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I
Dept. of Behavioural Medicine, Astra Hässle AB, Sweden.
D002986:Clinical Trials as Topic; D004341:Drug Evaluation / Q000379:methods; D006302:Health Services Research / Q000379:methods*; D006801:Humans; D011788:Quality of Life; D014481:United States; D014486:United States Food and Drug Administration