The European Medicines Agency has adopted what it calls a landmark policy in expanding access to clinical data but transparency campaigners, while welcoming certain elements, are concerned vital information will be redacted from its reports.
One striking point is that the EMA has abandoned a much-criticised proposal would have just allowed ‘on-screen only’ access in restricted areas. Now, “the public can either browse or search the data on screen, or download, print and save the information”, the agency notes, stressing that the reports cannot be used for commercial purposes.
All well and good but then comes the problem. The EMA notes that in general clinical study reports (CSRs) are not commercially sensitive but “information that, in limited instances, may be considered commercially confidential will be redacted”, though “the decision on such redactions lies with the agency”, not drugmakers.
The redaction issue has irked the AllTrials campaign, the initiative founded by Bad Science, the BMJ, the Centre for Evidence-based Medicine at Oxford University, Cochrane Collaboration, James Lind Initiative, PLOS and Sense About Science. The latter group’s managing director, Tracey Brown, was fine about the EMA reversing “the ridiculous proposal that researchers would only be able to see information from clinical trials on-screen in a sealed room”.
Redaction rules row
However, she argued that “it is still the case that trial sponsors might be able to cut out any information they don’t want others to see. 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. The EMA should ensure that its rules on redaction reflect this approach”.
Carl Heneghan, director of the Centre for Evidence Based Medicine was more positive, saying the EMA’s announcement on the publication of CSRs “is a major step forward and represents a real shift in favour of ensuring research data is shared routinely and re-used effectively in the public interest”. The EMA’s plan is to start making CSRs available from January 2015, “and by recognising the importance of this data, it sets a standard for data transparency now and in the future”.
However, Prof Heneghan added that what “it also clearly demonstrates is the need to ensure CSRs are made available for all of those drugs that are in use today and predate this ruling”. He said the EMA’s consultation “should ensure the substantial benefits and impact on global health of individual data are communicated clearly to patients, healthcare professionals, academia and industry”, while its attitude to redactions “should be independently audited to ensure overzealous approaches do not hinder access”.
Ben Goldacre, author of best-seller Bad Pharma, was less impressed by the news, saying that the EMA records “are woefully incomplete for informed decision-making” as the agency “only holds CSRs for a small proportion of all the trials done on all the medicines we use today”. He believes that “we need a radical overhaul giving retrospective transparency on all CSRs from industry, and clear transparency on methods and results for all trials done by academics”.
Dr Goldacre went on to say that the policy “does nothing to move forward on the safe sharing of individual patient data – whilst respecting patient privacy – which was promised by EMA in 2012” and “there are serious concerns around the redactions process”. He noted that the EMA reached an agreement this year with AbbVie “to censor information on protocol changes from the public release of a CSR [which] are precisely the kind of information that researchers need, to make an informed decision about whether that trial was a ‘fair test’ of the treatment”.
These criticisms did not dampen the enthusiasm of EMA executive director Guido Rasi who said “the adoption of this policy sets a new standard for transparency in public health and pharmaceutical R&D”. He added that this “unprecedented level of access to clinical reports will benefit patients, healthcare professionals, academia and industry”.
The EMA believes the new policy will “increase trust in its regulatory work as it will allow the general public to better understand the agency’s decision-making”. In addition, academics and researchers “will be able to re-assess data sets”, while “the publication of clinical reports will also help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines”.