Subjective Outcome Measures of Drug Efficacy

¹ Roche Pharma, Neuilly-sur-Seine, France
² INSERM U472, Hôpital Paul Brousse, Villejuif, France
³ CNAMTS, Paris, France

Received: 6 May 2003
Accepted: 26 May 2003

Abstract

The use of subjective outcome measures for assessing drug efficacy varies according to the disease in question. Subjective outcome measures used to complement an objective outcome measure can clearly claim the status of a main outcome measure. The validation of an instrument follows an appropriate methodology that focuses on two points: the methods used for its construction are set out and its performance is evaluated in a study. In drug evaluation, the importance of the subjective outcome measure should be discussed, depending on the aim and the disease. The methodology of the study obeys the same rules as when an objective outcome measure is used. The issue of the clinical significance of the results should be broached and discussed. Subjective outcome measures deserve to be considered in the evaluation of the drug because they provide a different and complementary perspective on the disease and the patient, both at the time of obtaining the marketing authorisation or when reassessing a drug.