[Clinical evaluation: from intermediate to surrogate criteria].
The 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.
Boissel
J P
JP
Hôpital Neuro-Cardiologique, Université Claude Bernard, Service de Pharmacologie Clinique, Lyon, France.
Perret
L
L
Bouvenot
G
G
Castaigne
A
A
Gérard-Coué
M J
MJ
Maillère
P
P
Mismetti
P
P
Vray
M
M
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy; D004341:Drug Evaluation; D006526:Hepatitis C / Q000188:drug therapy; D006973:Hypertension / Q000188:drug therapy; D010024:Osteoporosis / Q000188:drug therapy; D015203:Reproducibility of Results; D009626:Terminology as Topic; D013923:Thromboembolism / Q000188:drug therapy