EU preps simplified clinical trial rules for drug developers

Clinical research organizations operating in Europe may soon get some help from EU officials. New rules tightening up on the monitoring and reporting of clinical studies complicated matters for anyone hosting a trial on the continent, often requiring companies to file separate applications in each country they recruit patients in. But with the number of clinical studies down 15%, Reuters reports that EU officials are looking for ways to streamline the process, eliminating some of the red tape associated with the work.

A new EU submission system envisions a one-stop shop for CROs and others developing new drugs. And that could have a big impact on the rare disease field, where a paucity of patients often forces developers to host trial sites in various countries. By simplifying the process, Europe hopes to compete better with low-cost countries like India and China. German health spokesman Peter Liese says that conducting more studies in Europe will also safeguard patients from the results of substandard studies in Third World countries.

"It's a delicate balance, but we think we have a responsibility there for the poor people that risk their life in India, but also for the patient in Europe that might not be treated in the optimal way when the data are not generated under reliable conditions," Liese tells Reuters.

There's also a move on to strip down the regulatory process for academics, charities and others looking to mount a quick trial of approved drugs when there's a limited commercial opportunity to explore. Speeding up the studies should also reduce costs.

- here's the story from Reuters

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