After setting out principles under which the industry is prepared to open up clinical study reports, the European Federation of Pharmaceutical Industries and Associations (EFPIA) is trying to reach a consensus with campaigners and regulators on how they should be applied in practice.
By Nuala Moran
Advances in the ability to interrogate the mountains of data generated by healthcare systems and biomedical research – including the huge volumes of data generated in clinical trials – are beginning to deliver important improvements in public health and individual care.
However, making this class of data available must be handled in a sensitive and measured way that both protects patient privacy and respects commercial confidentiality. The issues involved in achieving such a balance have been thrown into sharp relief in the case of clinical trials data, with the debate polarising between academic researchers who want all information to be made available and companies that have invested large amounts of time and resources in clinical development, seeking to protect their commercial rights.
Now, under new commitments made in July, the industry has said it will “dramatically increase” the amount of information it makes available. But EFPIA insists this cannot be a free-for-all, saying it is necessary to ensure data is shared in a way that protects individual patient privacy whilst maximising public health. This means that rather than the broad brush approach being advocated by the European Union, a system needs to be put in place where the issues of patient and commercial confidentiality can be considered on a case-by-case basis.
The industry is moving to find a consensus in advance of European Medicines Agency (EMA) plans to bring in a new data transparency regime in January 2014, under which it is proposing to systematically release clinical study reports on all drugs it approves. The EMA is currently running a consultation process to formulate the new transparency rules, and is due to publish its final policy on 30 November. However, it has already made it clear that in its view clinical trials data cannot be considered to be commercially confidential.
The question of the legal definition of commercial confidentiality lies behind the interim injunctions the General Court of the European Union granted in April to AbbVie and InterMune, preventing disclosure of documents relating to Humira (adalimumab) and Estriet (perfidenone), respectively. On the face of it, the injunctions support the industry’s stance on commercial confidentiality. But the Court’s rulings also put the industry under pressure to find a formula for advancing transparency that campaigners, regulators and companies could all sign up to.
This led on to the publication by EFPIA of a set of principles it is recommending to its members, to “commit to sharing upon request from qualified scientific and medical researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and the EU as necessary for conducting legitimate research.”
Richard Bergström, Director General of EFPIA, said, “Member companies are committed to the responsible sharing of clinical trial data in a manner that safeguards the privacy of patients, respects the integrity of national regulatory systems and maintains incentives for investment in clinical research in Europe. Implementation of these principles will begin on 1 January 2014, and we are now helping to bring together all stakeholders to reach a consensus and prepare a roadmap as we enter this new era of responsible clinical trial data transparency.”
These principles for responsible data sharing have been welcomed as an important first step by some campaigners for greater transparency. However, it is now necessary to reach a consensus on how the principles are put into effect in a way that will both satisfy the requirements of the researchers and protect the commercial interests of companies. And – bearing in mind that regulatory submissions can run to millions of pages – the system needs to be both workable and not generate a massive administrative overhead.
Having set out the principles, EFPIA is now staging a workshop at which key public health stakeholders will meet to consider the practical implications and set out guidelines for sharing clinical trials data with qualified researchers and with patients.
The event, A roadmap for sharing clinical trial data to be held in Brussels on 27 August will examine how data transparency should work in practice. Delegates will also look for best practice in implementation and make initial assessments of the kind of physical infrastructure that will be needed to allow this data sharing to take place in a managed and consistent fashion.
EFPIA says its objective is that any researcher who asks a legitimate question should be able to get the data on request, but that appropriate and agreed controls must be in place to maintain incentives to invest in clinical research.
To achieve this, companies will implement a system for receiving and reviewing requests. Each company will set up an independent review board to assess requests for data, and will publish details and outcomes of all requests. Researchers granted access must agree not to hand information to third parties and will be expected to publish their findings.
Amongst those giving their views at the workshop will be Ben Goldacre, Wellcome Research Fellow at the London School of Hygiene and Tropical Medicine, one of the leading campaigners for greater transparency. A comment made by Goldacre when EFPIA published its data sharing principles highlights the gulf that needs to be bridged. “Overall the proposals here are no meaningful alternative to simple, clear transparency on all trials,” Goldacre told AllTrials, the campaign set up to push for open publication of all clinical trials results. “All results from all trials for all uses of currently prescribed treatments must be made available, if doctors and patients are to make informed decisions about which treatment is best. Where we have anything short of this, patients are exposed to unnecessary harm,” Goldacre said.
In the lead up to the workshop the key issues will be discussed and laid out in interviews with opinion leaders who are taking part in the event. Immediately after, the highlights will be reported here, followed by a fuller report and checklist of actions to guide implementation of the data transparency principles.
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A roadmap for sharing clinical trial data
August 27th, 13:00 -17:00
Vlerick Business School, Manhattan Centre, Place Rogier, 21 Avenue du Boulevard, Brussels
