EFPIA’s Dr Neil Weir and Bad Pharma author Dr Ben Goldacre at the meeting (pic: EMA/Nada Photography)
The European Medicines Agency (EMA) has published a report on transparency in clinical trials in the wake of its stakeholder meeting on the topic in November.
The report reiterates the EMA’s position – voiced strongly at the November 22 meeting – that clinical data will have to be published, although it reveals there is still considerable disagreement about how this should be done.
In broad terms, the workshop divided along ‘traditional’ lines, with those calling for complete transparency to avoid potential for interpretation bias in one camp and others – mainly from industry – calling for data access on a case-by-case basis to protect intellectual property rights.
One of the industry voices at the meeting was Dr Neil Weir, who sits within EFPIA’s research director group and is senior vice president of global research at UCB.
He told the meeting that “we may need an independent judge to decide what data should be accessible”, adding: “In terms of the greater good, we must find a balance between fostering great science and an acceptable commercial environment.”
Meanwhile, Hans-Georg Eichler, the EMA’s senior medical officer, said at the meeting that the move towards transparency “is irreversible” and – despite the opposing viewpoints – the agency intends to bring a new policy into force as early as January 2014.
One of the main conclusions of the workshop was that the topic needed to be split into more manageable chunks, “each to be tackled by experts in that arena”, said Eichler. These advisory groups have been drawn up as follows:
• Protecting patient confidentiality
• Clinical-trial-data formats
• Rules of engagement
• Good analysis practice
• Legal aspects
The next stages for the project are receipt of nominations for membership of the advisory groups, which will take place this month, followed by initial meetings in January/February 2013, said the EMA.
Final advice from the groups – which the EMA may “adopt or politely refuse”, according to Eichler – should be made available by April 30, 2013, with a public consultation phase extending through the end of September.
The move comes amid a major overhaul of the EU’s rules governing clinical testing. Earlier this year the EC published proposals to simplify procedures relating to clinical trials in the first major revamp of the system since the introduction of the Clinical Trials Directive (CTD) 11 years ago.
Greater transparency on the results and recruitment status of studies was one of the hallmarks of that proposal document.