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Stricter rules on trials used in European marketing applications

EMA tightens up ethical standards to cope with globalisation of clinical trials

Clinical trials used to support European marketing applications will face stricter rules from May.

European regulators will no longer consider trials whose protocol was not first submitted to an independent ethics committee or those conducted without the informed consent of participants.

Trial data will also be disqualified if non-compliance with the rules “significantly affects the rights, safety or well-being of the subjects or the quality and integrity of the data reported”.

The European Medicines Agency (EMA) said the move is part of its strategy to deal with the increasing globalisation of clinical trials, but it also follows pressure from MEPs.

Last year Margrete Auken, Danish Green Party MEP, said Europe should treat unethical clinical trials with the same gravity as organ trafficking and called for companies to be "named and shamed".

The EMA's new final reflection paper on ethical and good clinical practice (GCP) aspects of clinical trials will come into force on May 1, 2012, and aims to ensure clinical trials submitted to it meet the required ethical and GCP standards.

“No matter where you stand today, most clinical trials are being conducted somewhere else in the world, under a different regulatory framework and in a different cultural setting,” the EMA said in a statement.

This means regulators across the world have to rely on the same trial data when deciding whether to approve a new medicine.

Last year around 120,000 clinical trials took place in 178 countries and this globalisation of research has seen China, Russia, India, Brazil, Poland and South Africa emerge as key hubs for pharma studies in recent years.

Trials conducted outside the EU but used in marketing authorisation applications to EU regulatory authorities are expected to meet the same ethical standards as those conducted within Europe.

But a number of high profile cases have called standards into question. Most notable was Pfizer's 1996 trial of its meningitis drug Trovan in Nigeria, in which 11 children died. The pharma company reached an out of court settlement to the case in 2009 and began paying compensation to the families involved last year.

More recently GlaxoSmithKline this year rebuffed claims it acted unethically by failing to secure proper consent from the parents of children enrolled in a study of its pneumococcal vaccine Synflorix in Argentina.

The EMA says it will work towards increasing international cooperation on trial regulation and set out ways regulators can gain assurance that ethical and GCP standards are applied to clinical trials for human medicines, both during the development and during the marketing-authorisation-application phase.

The EMA's reflection paper emphasises the role of independent local ethics committees in the oversight of clinical trials and stresses the importance of obtaining trial subjects' consent.

The paper is endorsed by the EMA's scientific advisory committee the CHMP, the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMD-h), the EMA's Management Board and the Heads of EU Medicines Agencies.

17th April 2012

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