Report on EPPOSI workshop on clinical trials (22/04/09)

When the Clinical Trials Directive came into force in 2004, it arrived with dire warnings. Many said it would bring about the end of clinical research, especially for academia. Five years on, the Directive is still here, and clinical trials are still here. True, there are also problems, and in a meeting in Brussels on 22 April, stakeholders from patients’ organisations, academia, industry, regulators and policy makers came together under the auspices of EPPOSI to look at some hard data about the clinical research landscape in Europe, and to consider what changes might need to be made to the Directive.

It was a day of two halves. In the first part, delegates heard presentations from the European Commission, from the Clinical Trials Facilitation Group, from industry and from patients. The centrepiece was the much-awaited first public – albeit preliminary – report of results from the ICREL project, which is attempting to measure the impact of European legislation on clinical research. In the second half, delegates split up into a range of workshops to come up with specific proposals. They then came back together to agree on a small number of key suggestions for policy action. This report outlines the discussion and the points made in the first half of the day, and concentrates then on the recommendations to emerge from the plenary and break-out discussions. The results are put forward as a tool for the Commission and stakeholders to use in the continuing discussion of how to advance Europe’s conduct of clinical trials.

Read the report :