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- J P Boissel, L Perret, G Bouvenot, A Castaigne, M J Gérard-Coué, P Maillère, P Mismetti, and M Vray.
- Hôpital Neuro-Cardiologique, Université Claude Bernard, Service de Pharmacologie Clinique, Lyon, France.
- Therapie. 1997 Jul 1; 52 (4): 281-5.
AbstractThe development and evaluation of new drugs often rely on surrogacy. An intermediate outcome becomes a surrogate outcome if it fulfils certain criteria, it should be easier to measure compared with the clinical outcome, a statistical relationship should exist between the clinical outcome and the surrogate outcome, a relation should exist allowing prediction of the degree of clinical effect based on the measured effect on the surrogate outcome. Development and authorization of drugs today often rely on so-called surrogate outcomes. Is this use sound? The validity of such outcomes has been reviewed in different therapeutic areas: hypertension, venous thromboembolism, AIDS, osteoporosis, hepatitis C. Based on this review, a pragmatic strategy is proposed which allows for the validation and proper use of surrogate outcomes.
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