Clinical Trial Data: Will the EU go Open Kimono?

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  • 03/24/2014

The Wall Street Journal reports that, “Drug companies and researchers will no longer be able to withhold the results of unfavorable clinical trials, if changes to European law are passed as expected next month.”

The new law would require the results of all trials plus a full clinical-study report to be published within a year of the trial ending. The European Parliament is expected to vote on the new legislation April 3, and it would come into force in 2016.

What the Journal did not report was that in May 2013 the General Court of the European Union prohibited the Euro­pean Medicines Agency from releas­ing data from two AbbVie and Inter­mune trials in an interim ruling, part of a challenge by the two drugmakers to the agency’s decision to grant access to information the companies provid­ed as part of their market approval ap­plications. The challenge is the first to be made to the EMA’s three-year old access-to-documents policy.

The Journal, “Around half of all trial results go unpublished, according to current estimates, including a 2009 paper that looked at 677 studies conducted in different countries. A 2012 paper found just 45% of 635 U.S. National Institutes of Health-sponsored trials were published within 30 months of completion.”

Unreported is that in 2000, the National Institutes of Health (NIH) launched to provide public access to information on clinical studies.  Although it initially contained information primarily on NIH-funded research, it has been expanded to include both publicly and privately supported clinical research. 

Since the launch of the site, it has been enhanced to significantly increase data sharing. The database includes information on nearly 140,000 clinical trials in all 50 states and 182 countries. 

Is anyone accessing this wealth of information? Yes!  The NIH reported last year that “receives more than 95 million page views per month and 60,000 unique visitors daily.

At the July 2013 Clinical Trials Disclosure and Transparency Summit, Sir Alasdair Breckenridge, former Chairman of the MHRA and currently the Chair of United Kingdom’s Department of Health Emerging Science and Bioethics Advisory Committee, noted that transparency is “a process without a beginning or an end. It is a continuum.” And, “Transparency is like feeding a hungry dog – you more you give it, the more it wants.”

Sir A. suggested four key questions:

(1) Should the public have access to data on which regulatory decisions are taken?

(2) What are the advantages and disadvantages of increased transparency?

(3) What are the key distinctions between transparency and communication (specifically the issue of public health literacy and numeracy – and the “road testing” of released information)?

(4) Will increased transparency lead to increased trust in regulators and industry?

On that last point, Dr. Breckenridge points out that increased transparency does not lead to increased trust. Trust depends on perceptions of honesty and competence, and transparency may expose inherent inefficiencies in a system. And that’s a good thing – if we really mean to make the most of transparency.

Transparency cannot be “for thee but not for me.”

And he offers five keystones for moving forward:

(1) Agreement on timing of release of information

(2) Agreement on nature of information to be released

(3) Standards of protection of personalized data

(4) Standards for meta-analyses

(5) Rules of engagement for observational studies

Per the European Parliament vote, some policy issues to consider:

* Should transparency be a government dictate or a working collaboration between interested parties both private and public – and what role should patients play.

* Should there be formalized transparency consortia? Should it be global?

* What are the implications for intellectual property and the connected question of incentivizing (or dis-incentivizing) investment in innovation? Is transparency a Trojan horse to attack patents and intellectual property rights?

* Can transparency become a competitive advantage as well as a public health imperative?

After all, good things happen when everybody wins.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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