EMA to revise clinical trial guidelines
The European Medicines Agency (EMA) has announced that it will conduct a review in an attempt to revise its guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation.
The review will identify areas that need to be looked at in the light of the Rennes clinical trial tragedy, which led to the death of one participant and the hospitalisation of five others. The EMA will take into account the findings of two separate reports from French authorities which criticised the pharmaceutical company and the clinical research organisation which conducted the trial, Bial and Biotrial.
Both reports include a set of recommendations on the requirements for authorisation and the undertaking of first-in-human clinical trials which the EMA will examine and consider.
With a focus on best practice and guidance, the EMA aims to agree a concept paper by July identifying areas that could be changed in order to minimise the risk of similar accidents. This concept paper will form the basis for an EU-wide review of the guidelines.
The review will involve two groups of experts. One will look at the pre-clinical aspects and the data needed from laboratory tests or animal studies to safely initiate first tests in humans. The other group will look at the clinical aspects of the design of first-in-human trials and how these could be improved to better ensure the safety of human volunteers taking part in trials.
The EMA does point out that since 2005, 14,700 phase I clinical trials involving 305,000 subjects have been conducted in the EU. In that time, only one other severe incident, which occurred in London in 2006, has been reported in the EU.
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