Science charity: EMA U-turn on trial transparency is ‘backward step’
The editors of the BMJ (British Medical Journal) and the Cochrane Library, the head of UK charity Sense about Science, and science writer Ben Goldacre were among the committee members of the All Trials campaign group who complained about a perceived U-turn in EMA data policy.
They claimed researchers will have to view clinical study reports on-screen without saving or printing and that researchers are worried about the “severe” terms of access, which could put them at risk of legal action “if they find something a company doesn’t like.”
“If the EMA allows its new policy to be based on out of date attitudes it risks losing the trust of patients, policy makers and healthcare professionals,” said the open letter.
‘It’s a backward step’
Sense about Science’s Head of Campaigns told Outsourcing-Pharma.com that although the EMA had pledged last year to be proactively transparent and publish all clinical information it received from licensing applications, the agency had performed an about-turn.
Sile Lane told us Sense about Science has seen the EMA’s most recent data sharing policy, due to be ratified on June 12. The EMA has not shared the document with the media.
“It’s a backward step,” she said. “Firstly, as part of the terms of use researchers would have to sign up to, they would have on-screen only access.
“Basically they can’t print or share or edit or make notes on the clinical study reports the EMA will allow them access to. They’ll have to register for access and EMA will allow them into an IT infrastructure – just be able to view the data.
“Researchers tell us this will make their jobs almost impossible. They need to be able to compare studies, and share information across teams – researchers don’t work in isolation.
Scrutinising decisions made by regulators without notes is unviable because reports can reach 1000 pages, she said.
‘Legal chill’
Lane also told us she feared a “legal chill” if the new rules pass. “Part of these terms of use will be asking researchers to sign up to a clause saying third parties will be able to take a legal case directly against researchers if they believe researchers didn’t stick to terms of use.
“But the terms of use are so complex and unwieldy. It’s a risk with high legal costs.”
Researchers’ understanding is that these third parties will be trial sponsors, Lane told us.
‘Very strange’ change of mind
The proposed rules are a marked change from the EMA’s agreement with April’s EU Clinical Trial legislation. The ruling by the European Parliament is considered to enshrine in law that information in clinical trial reports should not generally be considered confidential.
“I assume when the EMA put out their consultation one year ago they heard from some quarters that it should be kept commercially confidential. [For instance] we heard from Abbvie’s lawyer that he thought that [even] adverse events are commercially confidential,” Lane told us.
“It’s very strange that the EMA has gone back on this – some companies and most academic institutes and professional bodies are changing the culture of secrecy and moving forward.”
The European Ombudsman Emily O’Reilly also expressed her concern at the “significant change of policy” and said it could violate EU law by limiting public access to documents.
A spokeswoman for the EMA directed Outsourcing-Pharma.com to a rebuttal from the Agency’s director to Sile Lane, in which Guido Rasi said the EMA “maintains its commitment to increasing transparency of clinical trial data,” and that it considers “the vast majority of data within clinical study reports are not commercially confidential information.”
When contacted Abbvie told us its "highest priority is to develop and provide patients with medicines that are safe and effective. A responsible process of data sharing, that protects both patients' health and our ability to compete, is possible and would benefit society as a whole.
"All information relevant to the safe use of our products, whether it is gathered pre-approval in clinical studies or after approval through post-market surveillance is gathered, analyzed, and shared with regulators world-wide. A massive amount of such information is made publicly available as well. And AbbVie is willing to release even more such information to researchers who want to access our raw data, including safety data, to do their own studies to advance science."
