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25 Mayıs 2010

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EC proposal on new clinical trial rules not expected until late 2011
22 April 2010
Ian Schofield
The European Commission says that the consultation exercise on the review of the EU clinical trials directive has yielded some useful information on the shortcomings of the legislation and that it is now looking at the various policy options for tackling them.

However, given the complexity of the issues involved and uncertainty over what kind of legislative instrument should be used, the process is likely to be a lengthy one. The commission's directorate general for health and consumers (DG Sanco) says it does not envisage adopting any new legislative proposals until October 2011.

Preparations for an overhaul of the EU clinical trials directive (No 2001/20/EC) have been under way for some time, after its shortcomings came under fire from both industry and academic sponsors. Problems included divergent application of the directive by the member states, an increased administrative burden, and the fact that the directive does not take account of the increasingly global scale of clinical trials.

In 2008, the commission said it planned to look at ways of improving the functioning of the directive and putting in place a modern regulatory framework that:

reflected the needs of the multinational research environment and the highly innovative research-based pharmaceutical sector;
was adapted to practical requirements and constraints without compromising patient safety; and
addressed the global dimension of clinical trials in terms of global alignment and meeting good clinical practice standards.
To get stakeholder input on these issues, the commission ran a public consultation from 9 October 2009 to 8 January 2010, which drew observations and suggestions from a wide range of parties including industry, regulators and member states (scripnews.com, 11 February 2010).

"roadmap" outlines ways forward

On the basis of these responses and other input, DG Sanco has produced a "roadmap" summarising the issues involved and looking at the best way of dealing with them. This gives a clearer view as to the policy options it has in mind.

In terms of addressing the needs of the pharmaceutical industry, DG Sanco is considering three options: introducing a streamlined clinical trial authorisation based on a joint assessment and follow-up by member states; clarifying certain aspects of the directive to reduce divergences among member states; and adopting the directive as a regulation to avoid divergent transpositions.

As for the practical requirements, it says it may revise the directive and/or review the implementing guidelines.

To take account of the global nature of clinical trials, DG Sanco will consider stronger international dialogue and co-operation, including capacity building in third countries; stronger alignment of existing EU implementing guidelines with international developments; and closer scrutiny of clinical trials performed in third countries where the results are used in EU regulatory procedures.

In general, says the commission, there are four main instruments that could be used to achieve these aims: amending the directive, replacing it (partly) by a regulation, revising the EU guidelines and infringement procedures, and relying on voluntary member state co-operation in order to address the problems.

The socio-economic benefits of the various options include improving the safety and well-being of clinical trial participants, reducing administrative costs and other burdens for sponsors and investigators, strengthening the reliability of global clinical trials, and facilitating clinical research, particularly multinational trials, according to DG Sanco. This last is particularly important because multinational trials often involve treatments for rare diseases where additional research is crucial.

DG Sanco says it will continue to gather additional data this year regarding the impact of clinical research on human health, through both in-house expertise and dedicated meetings with experts and other stakeholders, in order to help it decide on the best route forward. It does not plan to bring in any external contractors.

Other moves

Separately, the commission has just issued a revised version of its 2005 guidance for companies seeking clinical trial authorisation (scripnews.com, 7 April 2010).

In other recent clinical trial development news, the EU Heads of Medicines Agencies' Clinical Trials Facilitation Group has expanded a pilot programme offering co-ordinated and simultaneous review of multinational clinical trial applications (scripnews.com, 9 April 2010).

The commission is also seeking feedback on the future of an R&D programme that was set up to accelerate the development of new drugs against HIV/AIDS, malaria and tuberculosis. The programme's current focus is on conducting Phase II and III clinical trials in Sub-Saharan Africa (scripnews.com, 14 April 2010).

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