The EU medicines body has been discussing the final wording of its draft policy on sharing data from clinical trials. We and hundreds of you have been urging them not to take a backwards step on transparency. The Management Board of the European Medicines Agency (EMA) sets policies for the EMA and delayed agreeing the draft policy until October to allow more time for discussion. So we’ve written to all of the members of the Board urging them to return to the earlier proposals.
Read our letter:
We are writing to you as a member of the Management Board of the European Medicines Agency with our concerns about the Agency’s draft policy “Publication and access to clinical-trial data.” Last year, hundreds of supporters of the AllTrials campaign contributed to the Agency’s consultation on this policy. We welcomed the Agency’s proposals which would have seen Clinical Study Reports published proactively and openly in line with an Agency policy that the information in those reports should not generally be considered commercially confidential.
We wrote to Professor Guido Rasi in May 2014 about our concerns that the draft of the policy shared with some stakeholders at meetings that month introduced barriers that would make it all but useless to independent researchers. We welcomed the news that you have delayed formally adopting the policy for more discussion and we want to reiterate four areas of particular concern:
1. We are pleased to hear that Board members support “the more user-friendly amendments proposed by EMA Executive Director Guido Rasi that would allow data to be downloaded, saved or printed for academic and non-commercial research purposes.” We urge you to support these amendments and reject earlier versions of the policy that would mean that Clinical Study Reports would only be available for viewing on screen. This restriction would make it nearly impossible for researchers to usefully scrutinise the documents. CSRs often contain thousands of pages of complex information. Research teams need to be able to share information and researchers have to be able to print or copy information such as outcome definitions, to make valid comparisons across studies. Your policy on access to CSRs as initially proposed could have made a genuine contribution to medical research. By limiting access to on-screen viewing it risks becoming a superficial and practically useless gesture.
2. The wording of the draft “Redaction Principles” policy is ambiguous, and where there is ambiguity, there is likely to be excessive redaction. For example, “statements/descriptions relating to objectives that are not supportive of a label claim and do not contribute to the overall benefit/risk evaluation” may be redacted. This would appear to suggest that any information on off-label uses of drugs will not be made available. While the Agency’s own use of these documents may be limited to a decision on one specific use of a treatment, in everyday clinical practice these same treatments are routinely and legally used by clinicians outside their marketing authorisation. This prescribing is based on published evidence that may be particularly vulnerable to dissemination bias, since evidence on off-label uses is frequently excluded from even voluntary codes of practice.
3. The “Redaction Principles” policy asks sponsors to submit two versions of a CSR from each trial: a standard version (CSR(a)) and a redacted version (CSR(b)). While this might be driven by a desire to lower the costs of transparency for the Agency, it puts primary responsibility for redacting in the hands of sponsors. How close CSR(a) is to CSR(b), and which parts are missing, may never be known to researchers granted access to CSR(b). Will there be an audit to explore whether redactions are proportionate or risk patient safety, and penalties for excessive redactions?
You have probably heard from some quarters that information from clinical trials is commercially confidential. We have heard one pharmaceutical company lawyer from AbbVie even go as far as claiming that information on adverse events should be kept as trade secrets. However some companies and most academic institutes are throwing off the culture of secrecy and moving forward. The recently agreed European Clinical Trials Directive will enshrine the policy that information in CSRs is not generally commercially confidential in law.
There is no good reason to introduce barriers to CSR access as the Agency’s draft policy does. We know you agree that allowing independent researchers to be free to scrutinize CSRs will have huge benefits for patients, doctors, pharmacists, regulators and researchers and that these will inform treatment decisions now and decisions about future research.
AllTrials is a campaign for all clinical trials to be registered and results reported supported by more than 79,000 people and 500 organisations worldwide, including regulators; medical schools and universities; medical bodies and Royal Colleges; consumer group BEUC; the European Patient’s Forum and more than 150 other patient groups from across Europe. The numbers of European citizens and organisations supporting it is growing every day and will continue to grow and press for change. We are entering a new era of medicine; one where medical practice is based on evidence openly available and critically appraised rather than on edicts and eminence. 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. We urge you to revise your policy to reflect your earlier support for the public interest in better medicine.
The AllTrials campaign steering committee:
Dr Ben Goldacre, Research Fellow in Epidemiology, London School of Hygiene and Tropical Medicine
Dr Fiona Godlee, Editor-in-chief BMJ
Professor Carl Heneghan, Director, Centre for Evidence-based Medicine
Dr David Tovey, Editor in Chief, The Cochrane Library
Dr Richard Lehman, GP
Sir Iain Chalmers, Coordinator, James Lind Initiative
Dr Virginia Barbour, Medicine Editorial Director, PLOS
Tracey Brown, Managing Director, Sense about Science
Update: The vote will be on 2nd October 2014.