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The European Medicines Agency (EMA) has made a landmark policy decision that will see it publish the clinical trial reports underpinning a medicine’s licence.
The clinical reports will be available for new drug applications from 1 January 2015 for scrutiny by the public and researchers. From 1 July 2015, the agency will provide access to clinical reports relating to applications for line extensions of indications for existing medicines.
Under the policy, users who want general information can search and browse data on screen after a simple registration process. Those who want to use the information for academic and non-commercial research purposes will need to provide more detailed information to the agency, including their affiliations and positions within their organisations. Any information that is considered commercially confidential will be redacted from the documents.
Sense About Science (SAS), a charity behind a campaign for all trial results to be published, believes the EMA’s new policy does not go far enough.
The EMA will have the final say on what may and may not be redacted, according to its Q&A document on the policy. However, SAS believes the policy leaves primary responsibility for redacting information in the hands of drug companies, so they will be able to suggest which information submitted to the EMA should be kept hidden. It may not be clear to the public and researchers if information has been kept hidden, according to SAS.
“Companies and other bodies that have embraced an open approach to their trials have made it clear that the need for redaction is very limited,” said Tracey Brown, the charity’s managing director. “The EMA should ensure that its rules on redaction reflect this approach.”
Carl Heneghan, director of the centre for evidence-based medicine in Oxford and a co-founder of the all trials campaign, wants the agency’s policy on redaction to be independently audited “to ensure overzealous approaches do not hinder access to important information”.
SAS is also concerned about the terms of use that contract researchers must sign before accessing records.
According to the EMA, “the terms of use are not intended to impose liability on users who comply with the terms, nor are they intended to create any additional layer of liability for academics or researchers stemming from their professional activity”.
But SAS says the terms allow drug companies to take direct legal action against researchers should they violate them, which “will introduce a new and unpredictable risk of high legal costs into routine academic work, effectively chilling researchers’ ability to use information relevant to patient care”.
The European Federation of Pharmaceutical Industries and Associations welcomed EMA’s policy, saying its member companies have committed to sharing study results with the public and individual patient data with researchers.
“It will be critical to ensure that there are meaningful controls to prevent misuse of released data, which would harm the ability of companies to develop new medical treatments for patients,” it added.
The EMA plans to make individual patient data available in the future, after ensuring patient privacy is adequately protected. It says the policy will complement the new EU Clinical Trials Regulation adopted by the European Parliament on 2 April 2014, which comes into force in 2016.
