title: [How to optimize the carrying out and the development of post-registration             studies].
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.
authors.affiliation: Laboratoire Sanofi, Paris, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Borel
authors.forename: Chrystel
authors.initials: C
authors.lastname: Jouan-Flahault
mesh_terms: D017277:Drug Approval; D004345:Drug Industry; D005060:Europe; D011358:Product Surveillance, Postmarketing / Q000191:economics / Q000379:methods*; D012107:Research Design