International Investigator-initiated Trials

The clinical-trial-directive (2001/20/EC) which is now implemented into national law in all countries of the European Union, has a huge impact on the planning and conduction of the important optimal-use-trials (investigator-initiateted trials; IITs). The ELN has the chance to share experience and ideas to solve the different problems, due to European fragmentation and specific national requirements. Therefore the information center initiated several projects to support IITs.

Setup of new working group: European LeukemiaNet - Expert committee (ELN-EC)

Members of the ELN are synergizing their power and knowledge in a new working group, facing the problems and create solutions for multinational Investigator-initiated-Trials (IITs), crossing the frontiers of Europe.

Stucture of ELN-EC
During the 6th ELN symposium in 2009, ELIC suggested to build up a new working group in between the ELN. Afterwards all members were adressed to show up their interest, to suggest someone from the community and to give a short overview about their international clinical trial activities resp. experience. The responders were collected and this leads to an intitial set-up of a new working group in between the ELN. All the members of the Expert Committee (ELN-EC) on International IITs are having practical experience in initiating clinical trials in the home country and even with multinational IITs.
Workshops on International IITs
European legislation on clinical trials
Links
Database of regulatory affairs by the EU funded projekt TREAT-NMD: http://skl14e.ukl.uni-freiburg.de/eu.treatnmd.reaf.web/staticContent.jsf Work Packages: Physicians, International IITs Science connection Wilsede: http://science-connections.com/Wilse ...

International Investigator-initiated Trials

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