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Published online 10 July 2009 | Nature | doi:10.1038/news.2009.662
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Approvals on trial
Researchers demand more harmonization of European rules for approving clinical studies.
Europe must streamline its system for approving clinical trials that take place in different countries, researchers and pharmaceutical-industry representatives told a meeting in Brussels on 7 July.
Despite efforts to harmonize the way European countries approve clinical trials, a researcher may see their proposed study rejected in one nation but approved in another.
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Hi, Researchers demand more harmonization of European rules for approving clinical studies. One central aspect is the rights of the participants or patients in such studies. Experience has shown that very often participants have no Knowledge of being part of a clinical studie. Regards Dr.Terence Hale
For multi-national trials that only involve EU countries, approval from the country of the host institution should be enough since all of them are supposed to follow the same rules.
Harmonisation of rules is fine, but such harmonisation must be in the interests of patients, rather than in those of the pharmaceutical industry. Alas, given the way the EU, with its tribes of lobbyists, works, one has reason to suspect that it will be the latter rather than the former which those who decide have in mind.... Henri PhD, MD