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Clinical Trials Directive still hampering academic medical research
Date:9/27/2007

picture at EU level of the outcome of the Directive three years after its coming into force, he said.

Because the follow-up time is quite short, it is still difficult to report final outcome figures, particularly given that some countries, such as France and The Netherlands, did not fully implement the Directive until 2006. But the data for non-commercial clinical research in general confirms that academic research, which represented around a quarter of all clinical trials of drugs before implementation, lost ground and represents now less than one fifth of newly started trials.

Although the size of the effect is below initially reported estimates from different sponsor organisations, the current trend remains negative. However, latest figures reported by national authorities indicate that the pre-implementation level for new clinical trial authorisations may be achieved again in the coming 12 months, at least for commercial trials.

Because the Directive changed the standards for trial reporting, many countries had to revise their way of compiling data and, as a result, the pre- and post-implementation statistics are not fully comparable. During the pre-implementation period, most authorities did not report many details. With the Directives coming-into-force, the new EudraCT database, currently only accessible by the authorities, now permits detailed analysis of the status of clinical drug research in Europe. But so far only some authorities have started to release detailed figures like research per different therapeutic indication, or per different sponsorship. In order to make this valuable data more easily available to sponsors and the research community, the European Commission, national authorities and the European Medicines Agency should improve reporting and widen public access to database statistics as part of their efforts to improve transparency, said Dr. Hartmann.

For both patients and doctors, non-commercial clinic
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Contact: Mary Rice
mary@mrcommunication.org
34-932-308-832
ECCO-the European CanCer Conference
Source:Eurekalert

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