Red tape could suffocate European clinical trials
pharmafile | October 22, 2003 | News story | |Â Â Â
New measures intended to improve the competitiveness of clinical trials in Europe could have the opposite effect, a leading research head has warned.
Prof Franoise Meunier, the head of Europe's leading cancer research organisation EORTC, says the European Directive on Good Clinical Practice, intended to harmonise EU guidelines and improve patient access to new medicines could lead to a 30% increase in trial costs and seriously undermine competitiveness.
Uneven uptake and differing interpretation of the Directive guidelines could be catastrophic for the EU-based industry when they come into force in May 2004, she said
"It remains to be seen whether the Directive will actually decrease the high level of complexity faced by investigators and promoters of research".
"Countries need to have clear rules and regulations in common if research is not to be seriously hampered by bureaucracy and misinformation", she added
Several key topics including ethical approval, the reporting of serious adverse events, drug label requirements and costs of non-sponsored trials are among those identified as needing most clarification and co-ordinated work.
The Directive has also failed to harmonise the disparate insurance requirements for clinical trials in member states or reflect the large amounts of academic research conducted across Europe.
"To succeed, its implementation into national laws must take pan-European research into account and also independent academic trials not aiming at drug registration", said Prof Meunier.
Cancer research was especially vulnerable given its complexity and the multi-disciplinary approach required, she told delegates at a conference in Frankfurt. Meanwhile existing fragmented rules across the EU were jeopardising progress in establishing state of the art treatment strategies, denying patients the benefits of advances and hampering Europe's ability to compete with countries outside Europe.
