Biotech firms call for reform of European clinical trials
pharmafile | October 25, 2007 | News story | Sales and Marketing |
Biotech and specialist pharma companies have called for changes to European clinical trials regulations, which they say have imposed a bureaucratic burden on smaller companies.
The UK's Bioindustry Association has joined counterparts from the continent in pushing for reform of the European Clinical Trials Directive.
Aisling Burnand, chief executive of the BioIndustry Association and chair of EuropaBios National Associations Council, said: "Differences in the implementation of the Directive by Member States have adversely impacted on the ability of companies to carry out multinational trials across Europe. The impact on small and medium sized companies is particularly significant because they do not have sufficient financial and manpower resources to deal with the additional administrative burden and consequent delays."
The association wants the Clinical Trials Directive uniformly implemented across the EU in order to support innovative research and improve patient care in Europe.
Introduced in May 2004, the Directive was intended to encourage research by standardising procedures across the EU and establish compliance with Good Clinical Practice, but UK academics have struggled with the extra cost and regulatory authorisation the Directive brought with it.
The additional bureaucracy has been blamed for delaying trials rather than accelerating the process, and there have been problems in the varying interpretations of the Directive across EU members.
To improve harmonisation and transparency in the operation of clinical trials, while ensuring public health protection, the BIA put forward five suggestions for the Directive (see below).
The BIA presented their recommendations at a joint European Commission – EMEA conference on the operation of the Directive, a meeting that offered stakeholders a chance to provide feedback on how the rules were being interpreted in different countries and offer advice for the future.
Aisling Burnand added: "We look forward to continuing to work with the European Commission, National Competent Authorities and EMEA to address the issues highlighted today, which would have a direct benefit of improving patient access to innovative medicines."
The BIA made clear they are not looking to scrap the Directive and start again, but merely modify some elements and how they are applied.
How to improve the Clinical Trials Directive
* Modify its language to reduce room for interpretation
* Streamline the current ethics review process to
accelerate the start of trials to allow patients faster access to innovative treatments
* Define the roles and scope of responsibilities of National Competent Authorities (NCAs) and Ethics Committees
* Strengthen the mandate of the Clinical Trial Facilitation Group to facilitate arbitration between Member States.
