Optimiser la réalisation et l’utilisation des études post-inscription

Abstract

Studies conducted in real clinical practice on drug prescription, drug use and consequences on patients and on the organizational scheme of treatments establish the basis of the evaluation of commercialized drugs when seeking renewal of their insurance coverage, anticipated reevaluation or safety issues. Time has come now for pharmaceutical companies to write a critical report on the operating procedures identifying the issues of the various operation phases (i.e.: conception, study conduct, use and interpretation of results). The report put forth various optimization axes through 17 concrete measures. Those measures concern several domains including the communication with Health Authorities, the necessity of specific methodological recommendations, a better involvement of partners, the improvement of the access to health databases, a better understanding of budget constraints, and more transparency in the evaluation process as well as in the interpretation of results.