The EU medicines body is about to take a backwards step on transparency. We’ve been urging them not to. We need your help – the EMA should delay finalising its draft clinical trials data sharing policy until concerns we and others have raised with them are addressed.
- The EU Ombudsman is concerned that the EMA’s new draft policy could violate EU law by limiting public access to documents.
- Glenis Willmott, the MEP who led the work on the EU’s new clinical trials law, is concerned that the policy would conflict with the law.
- Researchers who work with clinical trial data are worried about restrictions to access to clinical study reports and that the policy would only allow reports to be viewed on-screen but not saved, printed or shared. Researchers are also worried about redaction policies which would give trial sponsors control over what information is hidden.
- The European Consumers Organisation (BEUC), the European Association of Hospital Pharmacists and GIMBE (Italian) have also expressed their concerns.
We wrote to Professor Guido Rasi, Director of the EMA, on Monday 2nd June 2014. His reply did not satisfactorily address our concerns and contained discrepancies about the consultation. So we wrote back today and asked him to delay finalising the policy until these concerns are addressed.
2nd June 2014
Dear Professor Rasi
Re: Draft Publication and access to clinical-trial data policy (EMA/240810/2013)
Hundreds of supporters of the AllTrials campaign contributed last year to the Agency’s consultation on its draft policy “Publication and access to clinical-trial data.” We welcomed the EMA’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 are now concerned that the most recent draft of the policy as shared with some stakeholders at meetings this month introduces barriers that will make it all but useless to independent researchers.
We understand that there are four areas of particular concern:
1. Clinical Study Reports will only be available for viewing on screen and cannot be saved, downloaded, printed, copied, annotated or shared in any way. This will 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. It now 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 78,000 people and 470 organisations worldwide. The numbers of European citizens and organisations supporting it is growing every day and will continue to grow and press for change. We ask you to revise the policy to reflect your earlier support for the public interest in better medicine. 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
5 June 2014
Subject: EMA draft policy on proactive publication of and access to clinical trial data
Thank you for your letter of 2 June 2014 concerning the draft policy on proactive publication of and access to clinical trial data.
I very much welcome the constructive contributions we received from AllTrials supporters and I can assure you that the support we received has had an important impact on the draft policy that will be presented to the Agency’s Management Board next week.
You raise a number of concerns in your letter and I will try to address each in turn, but first let me be clear that the Agency maintains its commitment to increasing transparency of clinical trial data and that the vast majority of data within clinical study reports are not commercially confidential information, and this forms the starting point for our draft policy.
1. On-screen access to clinical study reports
It is important to understand that the Agency does not have law-making powers, and that the draft policy has been shaped in the absence of any specific legal provision mandating the EMA to publish documents submitted to the Agency by third parties, as is the case for some other EU agencies. Consequently a balanced approach was needed taking into account different stakeholders’ competing interests, within the limitations of the current legal framework.
While we have overcome many of the objections raised by stakeholders, there remain some that we have had to accept as real issues. It is as a consequence of these issues that we have found it necessary, in the context of this draft policy, to propose a managed publication process that includes that clinical data will be available in an on-screen only mode. This compromise allows access to clinical trial data, but at the same time aims to discourage unfair commercial use of the data.
The issue of the usefulness of on-screen access to data was discussed with academics during the whole consultation process and we do not accept that this is a superficial or useless gesture. The policy provides access to clinical trial data to all stakeholders, not just to academics, and the fact that it will be available as soon as a medicinal product has been through the decision-taking process, searchable and continuously available to whosoever wants to view them is a significant step forward in terms of transparency.
2. Redaction principles
I do not agree that the principles are either ambiguous or will permit excessive redaction. There will be no difference in the understanding of commercially confidential information and how it is applied to documents held by us that are requested through ‘access to documents’ or that will be proactively published by the Agency.
The starting point of the redaction principles is that clinical study reports do not in general contain commercially confidential information. The draft principles therefore contain just a small number of exceptions where the Agency will consider duly-justified requests from pharmaceutical companies. In all instances, the decision on what is and is not redacted is controlled by the Agency.
3. Redacting clinical study reports
One of the reasons for producing redaction principles is to ensure a clear and transparent understanding on the part of applicants, and indeed all stakeholders, of what we are prepared to consider. Under the draft policy, applicants will be asked to submit clinical study reports in view of their publication. If they believe that some elements should be redacted, then they may propose this.
As mentioned above, each and every proposed redaction will need to be justified by the applicant and the final decision on what is and is not redacted lies with the Agency. The extent of redaction will be clearly visible as always. As a public body, it is of course open to any stakeholder to challenge any instance in which redaction inconsistent with the redaction principles is suspected.
I believe that the actions of the Agency, backed up with the support of organisations like yours, have changed the debate over access to clinical trial data. There has been a clear change of direction, which will be reinforced with the clear legal framework that the clinical trials regulation brings. The proposed EMA policy will provide a ‘bridge’ until the regulation comes into force sometime after May 2016.
We have moved stakeholders closer together to a position that would not otherwise have been reached. Many stakeholders have shifted their position out of their comfort zone, in particular the pharmaceutical industry. I very much welcome this shift.
9th June 2014
Dear Professor Rasi
Re: Draft Publication and access to clinical-trial data policy (EMA/240810/2013)
Many thanks for your detailed and thoughtful reply to our letter on the draft data sharing policy. We appreciate you taking the time to respond so fully. However we continue to have concerns about the potential backward steps for transparency in the draft policy. In particular the supposed risks of transparency, and indeed the proposed policy itself, are dangerously vague and poorly specified.
1. Your letter says that usefulness of on-screen access to data was discussed with academics during the whole consultation process. Researchers who attended stakeholder meetings have told us that there was no discussion of on screen only access to clinical study reports. During the consultation process CSRs were always discussed as open access documents that would be proactively published. When did the discussion with stakeholders of on-screen-only access to CSRs occur and who were the stakeholders if not academics who use CSRs everyday in their work?
The policy to allow on screen only access to CSRs is more restrictive than the policies of some companies, many of whom allow CSRs to be downloaded and printed. What unfair commercial uses of CSRs does the Agency foresee if CSRs are available for download rather than cumbersomely presented for on-screen viewing only? Is there another problem on screen only access is intended to fix?
2. The EMA released millions of pages of CSRs between 2010 and 2013, on request, under the revised rules after the EU Ombudsman’s finding of maladministration against the Agency. If unfair commercial uses are a risk, what examples of this can the Agency show from this four year period of millions of pages of CSRs being released?
3. The influence of arguments against transparency on the Agency, especially given the recent backward steps, is undermining trust in the EMA among patients and professionals. What independent external scrutiny, audit, and transparency measures have they put in place around their redactions for commercially confidential material?
4. If the Agency believes that the liabilities and restrictions they are imposing on those viewing CSRs are proportionate and reasonable, it must specify these restrictions more tightly, to avoid researchers being exposed to potentially unlimited liability for costs in lengthy legal disputes with third parties.
We note that Glenis Willmot, MEP, the lead rapporteur on the new EU Clinical Trials Regulation, has also written to you to set out her concerns that the draft policy may be in conflict with the Regulation. The EU Ombudsman Emily O’Reilly has expressed concerns about the limits that would be placed on access to data and how it could be used. The Agency is due to finalise the policy at the Management Board Meeting on this week. In light of the concerns being expressed by researchers, regulators, Mrs Willmott and Ms O’Reilly, will you delay agreeing the policy until these concerns have been addressed?
The AllTrials campaign steering committee:
Dr Ben Goldacre, Bad Science
Dr Fiona Godlee, editor-in-chief BMJ
Professor Carl Heneghan, Centre for Evidence-based Medicine
Dr David Tovey, Cochrane Collaboration
Dr Richard Lehman
Sir Iain Chalmers, James Lind Initiative
Dr Virginia Barbour, PLOS
Tracey Brown, Sense About Science
The Agency is due to agree the policy on Thursday 12th June. Before then we need you to write to Paola Testori Coggi, the head of the directorate of the European Commission which oversees the EMA, asking her to tell the EMA not to finalise the policy until the concerns are satisfactorily addressed.
Here is an email that one of our supporters sent:
Dear Ms Paola Testori Coggi,
I am concerned to read the news that the EMA’s new draft of its data sharing policy for clinical trials appears to go wholly against the principles enshrined in the new Clinical Trials Regulation adopted overwhelmingly by the European Parliament in April this year.
The key element of the Regulation is transparency. The EMA’s new draft conflicts with this through the following elements:
- Data may be viewed on screen only, which will prevent any meaningful analysis;
- Companies performing trials will be allowed to redact information in the public version of the Clinical Study Reports;
I suggest that the finalisation of the EMA’s policy be delayed until these problems can be resolved, and that the finalised version be in harmony with the Regulation which will come into force in 2016.
I look forward to receiving your response.
Thanks and regards,