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TITLE Recommendations to the European Commission on the clinical trials directive.   clinicaltrialsdirective2004.pdf (24.1 KB)
Document ID LIB496
Document type Scientific advisory body opinion/advice
Issue date 01/09/2004
Original language of the document English
Document produced by Federation of the European Academies of Medicine organisation visiting card
Scientific domains
Policy domains
  • Health


Short description  The Federation of European Academies of Medicine welcomes the potential benefits for multinational collaboration in clinical research that could result from the Clinical Trials Directive (2001/20/EC). However the Federation continues to have some reservations on the application of this directive to academic, non-commercial, clinical trials which it would like to bring to the attention of the European Commission.
Abstract (focusing on the key recommendations)  High quality clinical research which aims at developing state of the art treatment - and
not at registering new compounds - is vital for improving the quality of patient care and
these "academic trials" need to be conducted on a multi-disciplinary basis and at the
European level.
"Academic trials" should be defined as studies not aiming at the registration or
commercialisation of a new agent ...

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