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

• Published in: British journal of clinical pharmacology Vol. 63; no. 2; pp. 159 - 162
• Main Authors: Van Luijn, Johan C. F., Gribnau, Frank W. J., Leufkens, Hubert G. M.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.02.2007; Blackwell Science; Blackwell Science Inc
• Subjects: added therapeutic value; Biological and medical sciences; Clinical Trials; Clinical Trials as Topic - statistics & numerical data; comparative information; Drug Approval - legislation & jurisprudence; EMEA; EPAR; European Union; Evaluation Studies as Topic; Humans; Legislation, Drug; Medical sciences; new active substance; Pharmacology. Drug treatments; randomized active‐control trial; Evaluation; EMEA; Information; added therapeutic value; Medicine; Randomization; Treatment; European Union; randomized active-control trial; Clinical trial; comparative information; new active substance; EPAR; Comparative study
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1111/j.1365-2125.2006.02812.x

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.