OECD advises countries to 'harmonise' clinical trial regulations

The OECD has urged governments to harmonise their clinical trial processes in a bid to encourage international collaboration in clinical research.

It believes that increasingly complicated and inconsistent clinical trial regulations are leading to delays, raising costs and reducing the number of trials carried out for non-commercial purposes.

Exclusively in the European Union, the number of applications for clinical trials dropped by 25 per cent between 2007 and 2011.

By encouraging international collaboration in quantitative analysis, it is hoped that more knowledge will be gained and procedures will be streamlined for conducting such work.

Such an approach will help to open up research in treatments driven by pressing health needs that offer few financial rewards for private companies, which is the case for diseases such as cystic fibrosis, paediatric diseases and pathologies in developing countries.

Professor Jacques Demotes, director of the European Clinical Research Infrastructure Network, who led the expert group that drafted the OECD Recommendation, said: " This policy guidance is optimised for reducing the burden of trial oversight as far as possible; it should greatly facilitate the current discussion on the new European regulations, and will make it much easier to run independent clinical trials in Europe."

Professor Susan Shurin, deputy-director of the US National Heart, Lung and Blood Institute, explained that the OECD's recommendation is a major achievement that shows a considerable amount of effort from high numbers of scientists, physicians and regulators.

This news comes after the European Society of Cardiology welcomed the European Commission's planned revision of the European Clinical Trials Directive (EUCTD).

The ESC has described the ruling as an important way of "simplifying, clarifying and streamlining" rules for carrying out trials in Europe.

The ESC European Affairs Committee coordinated the paper, which calls for the role of reporting member states to be extended to cover "aspects of an intrinsic ethical or national/local nature".