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Guidance for early clinical trials changed following death

The European Medicines Agency has revised its guidance on first-in-human clinical trials, in an effort to reduce the risks for participants following a fatal trial last year.

The revised guideline puts more emphasis on the need for the organisations running first-in-human trials to define the uncertainties associated with the drug being tested and to describe the potential risks and how these will be dealt with, the EMA said on 25 July.

The revision was necessary because trial designs have become more complex over the past 10 years, the agency said. Last year, one person died and five more were hospitalised during a first-in-human trial carried out in Rennes, France. Investigations into that trial identified shortcomings with how it was conducted, but found that it complied with existing regulations.

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