Pharmaceutical News and Updates

Disclosure by drug companies of results of clinical trials not necessary when they don’t lead to product development or commercialisation, but maybe useful for all parties involved.

Drug companies sponsoring human trials of possible new medications have ethical responsibilities to study participants and to science to disclose the results of their clinical research – even when product development is no longer being pursued, says a commentary co-authored by a leading drug researcher published online in Science Translational…
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ENCePP publishes the ‘guide on methodological standards in pharmacoepidemiology’

The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have published the ENCePP guide on methodological standards in pharmacoepidemiology, an important tool that reviews and gives direct electronic access to the main existing methodological guidance for research in pharmacoepidemiology and pharmacovigilance. The aim of…
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The EU executive is planning a major overhaul of the rules governing medical research amid a growing acceptance that a directive in place since 2004 has hampered clinical trials

The European Commission says it accepts that the implementation of the directive has been deeply flawed and will legislate to fix the problems by October 2011. The Commission’s health directorate – which was handed control of EU pharmaceutical policy earlier this year describes the Clinical Trials Directive as “arguably the most criticised…
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