The EU Clinical Trials Directive in 2011: Tweaks or Transformation?




After six years of use and critique, the European Union Clinical Trials Directive is scheduled for overhaul in 2011. Commissions, Conferences and consortia have met, discussed, evaluated and conferred.

In this paper Pharma IQ begins by taking a brief look at the development of the Clinical Trial Directive, then distils the substance and flavour of the debate currently taking place in scientific circles throughout the European Union and beyond. Our review summarises the major issues and possible remedies, then looks to the future as industry experts share their thoughts about what should happen in terms of reform and what is most likely to happen in 2011.

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