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What is already known about this subject • The assessment of the added therapeutic value of new medicines with a new active substance is hampered by the lack of appropriate comparative information. • Though the extent of this information gap is generally perceived as substantial, it has not been quantified. What this study adds • Information from active controlled trials was available in less than half of the new medicines studied, constituting a significant hurdle for evidence‐based decisionmaking on the use of new medicines in initial years following market introduction. 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.
Luijn et al. (Thu,) studied this question.