Scientific INformAtion for Policy Support in Europe
Sinapse home page

Library of scientific opinion & advice > Document description

Should you like to save, print or communicate the information related to this document, you can download this description page in a word processor compatible format.

DOCUMENT GENERAL INFORMATION

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

DOCUMENT TEXT

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 ...

[View the complete abstract]
Full Text

PAGE LOADING
Please wait...
Sinapse is currently processing your request.

This might take a few moments before the page can be displayed.
loading