Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization.

Abstract

AIMS: To investigate the availability of information about premarketing randomized active-control trials (RaCTs) involving medicines with a new active substance at the moment of market authorization in the European Union. METHODS: Information was obtained from the EMEA European Public Assessment Reports and the MEDLINE and EMBASE databases. RESULTS: Between 1999 and 2005, 48% of recently approved medicines (n = 122) had been studied in comparison with existing medicines at the moment of market authorization. About one-third of these trials were published and publicly available at that moment. CONCLUSIONS: For most new medicines evidence-based assessment of the (added) therapeutic value is not really possible at the moment of market authorization.