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OECD: EU should harmonize trial regulations

26 February 2013 | News | By BioSpectrum Bureau

OECD recommends member EU governments to harmonize their clinical trial approval processes

OECD recommends member EU governments to harmonize their clinical trial approval processes

Singapore: Increasingly complex and inconsistent clinical trial regulations are causing delays, raising costs and leading to a decline in the number of international trials that are conducted by academics for non-commerical purposes.

This has led the OECD to recommend its member governments that they harmonize their clinical trial approval processes, in order to boost medical research and help regulators overcome this problem.

The aim is to encourage international collaboration in clinical research and streamline procedures for conducting clinical trials. Moreover, a memorandum has been developed to explain the context and to facilitate the implementation of the principles contained in the recommendation.

Professor Jacques Demotes, director, European Clinical Research Infrastructure Network, who led the expert group that drafted the OECD recommendations, said that, "This policy guidance is optimized 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, US National Heart, Lung and Blood Institute, said that, "We have been struggling to conduct international trials addressing important health problems. This recommendation is a major achievement representing considerable effort by many scientists, physicians and regulators."

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