Pan European Clinical Trials under current EU regulations: A training course for data managers, study nurses and junior clinical investigators.
The 3rd training course run by the EURAMOS group & funded by the European Science Foundation (ESF) under the EUROCORES Programme European Clinical Trials (ECT) was held in Surrey, UK on 24-25 January 2008.
Investigator-initiated Clinical Trials face a multitude of challenges, particularly if they are to be performed according to the guidelines of Good Clinical Practice (GCP) because the translation of GCP into national laws and regulations differs between countries. This is even more true if these trials are performed on an international, Pan-European scale, as is EURAMOS-1. In order to assure patient safety in a way that complies with European and national rules and regulations, personnel involved in clinical trials must be trained intensively.
123 delegates from 12 countries attended the event which was held over two half-days and consisted of a combination of lectures and concurrent interactive group workshops. Delegates learnt about why clinical trials on very rare diseases such as the EURAMOS 1 trial are important, the challenges and difficulties of international collaboration and why it is worth the effort. They learnt more about the role of the European Science Foundation (ESF) in funding pan-European trials and the activities of the ECT-EUROCORES programme. They were also introduced to the European Clinical Research Infrastructures Network (ECRIN) programme. This is an EU-funded initiative, which through the connection of national networks of clinical research centres and clinical trials units, aims to develop an integrated European Infrastructure of clinical research able to provide support to clinical research in any medical field, and for any type of clinical research.
Highlights of the event included a video demonstration of the informed consent process with which Prof. Lesley Fallowfield illustrated the importance of the involvement of the clinician and how best to present clinical trial to patients and the choices that patients have to make. Dr Lizzie Burns presented an inspiring collection of paintings and photographs taken from a unique art project called "Bringing science to life".
This article can be read in full on the EURAMOS website