1^st IIT-Workshop

Authors: N. Gökbuget, K. Ihrig Universitätsklinikum Frankfurt, GermanyInformation Letter No.5, August 2008

Present regulative status

Intentionally the EU Clinical Trials-Directive 2001/20/EC planned to harmonize good clinical practices for clinical trials in any member state of the European Community. The directive assigned all member states to implement the regulatory requirements into national law until end of 2004. 7 years after its setting, it turns out, that:

• Member states needed about 6 years to amend their national law
• They did so in many different ways and harmonization is not achieved in a lot of aspects.
• Clinicians and study centers are still in process to adapt to the new regulatory requirements and finally
• This implementation made the situation of Investigator-initiated-trials (IITs) more difficult, not only on an European but also on a national level. Although IITs are recognized as a specific kind of a clinical trial with a specifically valuable impact for patients and research, the new time- and cost-consuming organisational demands escalated tremendously as elucidated by several publications ^1,2

Workshop on IIT s at the 5^th ELN Symposium

In order to address these specific difficulties for international IITs, a workshop was organized by EL IC, on the day before the 5th ELN symposium. The workshop bundled experience in initiation and conduct of IITs on a multinational level from both EL N internal working groups and other international European working groups as ECRIN (Dr. Kubiak, European Clinical Research Infrastructure Network), EORTC (Dr. Lambert, European Organisation on Research and Treatment of Cancer), EBMT (Prof. Dr. Apperly, European Group for Blood and Marrow Transplantation) and KPOH (Dr. Mauz-Körholz, Competence Network on Pediatric Oncology and Hematology). It attracted about 100 people from about 20 different countries and was evaluated afterwards.

Summary

All groups shared the same experience, as the initiation and conduct of international IITs is much harder than before EU directive 2001/20/EC. Furthermore, there is no harmonisation of approaches in the different European countries and nobody has a real overview. There is also a lack of information on available support (e.g. as offered by the ECRIN). Real alternatives to clinical trials e. g. registries are not available since they are subject to detailed regulations as well. On the other hand there are a lot of different approaches to deal with the situation and to find ways to initiate IITs. There are also few examples of international IITs (WP6, WP8) in the frame of the ELN which have started or are starting with great difficulties. Not surprisingly the costs have been exploded.

Next steps

Some WPs had started international IITs, and most of them plan to do so in the near future since this is a major goal of the network. The relevance of the topic was reflected by the large audience and the feedback from participants; the overall grading of the workshop in the evaluation was very good. Taking all that into account the suggestion of EL IC to set up an “ELN Expert Committee on International IITs” was highly welcomed. ELIC implemented as a first practical result another substructure HERE

ELIC wants to thank all speakers for their contribution: B. Simonsson, T. Büchner, P. Rousselot, N. Gökbuget, A. Westermann, E. Hellström-Lindberg, T. Barbui, Z. Doran, J. Hasford, K. Ihrig; C. Kubiak, F. Lambert, C. Mauz-Körholz. At the website you will find the presentations of the workshop and further information for investigators. All those who are interested in the ELN Expert Committee are invited to contact ELIC (ihrig@med.uni-frankfurt.de).

References

1. Hearn J, Sullivan R. The impact of the 'Clinical Trials' directive on the cost and conduct of noncommercial cancer trials in the UK. Eur.J Cancer 2007;43(1):8-13.
2. Rossion I. Consequences of the 12th AMG amendment on the conduct of non-commercial clinical trials. Urologe A 2005;44(12):1444-1448.