Display Settings:

Format

Send to:

Choose Destination
We are sorry, but NCBI web applications do not support your browser and may not function properly. More information
Br J Clin Pharmacol. 2007 Feb;63(2):159-62. Epub 2006 Dec 7.

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

Author information

  • 1Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Utrecht, The Netherlands.

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.

PMID:
17166187
[PubMed - indexed for MEDLINE]
PMCID:
PMC2000577
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Blackwell Publishing Icon for PubMed Central
    Loading ...
    Write to the Help Desk