Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization.
OBJECTIVE
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.
van Luijn
Johan C F
JC
Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Utrecht, The Netherlands.
Gribnau
Frank W J
FW
Leufkens
Hubert G M
HG
D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D005069:Evaluation Studies as Topic; D006801:Humans; D007880:Legislation, Drug