Use of the Foreign Studies: Transposition of the Results, Prediction of the Therapeutic Effects in the French Population, Modelling of the Public Health Interest

¹ Centre Hospitalo Universitaire de Besançon, Hôpital Saint Jacques, Besançon, France
² Lilly France, Suresnes, France
³ Merck Sharpe and Dohme, Paris, France

Corresponding author: zylberman_myriam@lilly.com

Abstract

More and more frequently, the health authorities and the French assessment agencies are led to issue Marketing Authorizations (MAs), give opinions on the eligibility for reimbursement of drugs or to draft recommendations for clinical practice based on the results of foreign studies. The results of these studies are more or less difficult to transpose to French practice. These difficulties generate varying degrees of uncertainty concerning the effect to be expected of a drug. A more or less extensive loss of effect is sometimes even predictable. Some of the difficulties in transposition are discussed in this article and proposals for action are made in order to allow one, in the long term, to predict in the most precise manner possible the effects to be expected from a drug in the French population and be able to verify this prediction at an interval from its eligibility for reimbursement.