Résumé
For several decades, the research for new innovative active molecules has increasingly involved the use of surrogates in order to accelerate research. This is why health systems are harder evaluating cases that contain only evidence based on surrogates. Unfortunately, the use of these surrogates usually ignores the confirmation of the substitutive character of the clinical criteria normally expected by health authorities as proof of efficacy for the drug.In this thesis, it is shown, how French and American health care systems evaluate these types of drugs, showing also the differences in market access generated by a different file methodology assessment. A benchmark is made on 29 cases of oncology drugs that had access to the US market in 2017 with validated or unvalidated surrogate endpoints.In this, there is a clear difference in terms of market access between the two countries, but with a responsibility not so much on use of surrogates than non-comparative clinical studies used as evidence of the efficacy of the drug.