Controversial new rules that could radically change the way clinical trials are run and reported in Europe have headed into the final stretch of negotiations before becoming law, after members of a key committee endorsed the draft regulations at the end of May. The proposals, which could replace the European Clinical Trials Directive (ECTD) in 2014 if they are made law, will now be put to EU member states prior to coming before the European Parliament for a final vote. But with that vote not due until October at the earliest, the stage is set for a war of words over the coming months as drug companies, nongovernmental organizations and science advocates all compete to influence how the final legislation regulates how much information about trials should be made public.

Bench press: Advocacy groups in Europe continue to push for access to drug trial data. Credit: Alamy

In the recent vote on 29 May, members of the European Parliament's Environment, Public Health and Food Safety Committee approved an amendment that would require researchers to register all clinical trials and publish summary results within a year of a study's completion. The proposal carries as-yet-undefined financial penalties for noncompliance. That was a “good move forward,” says Sile Lane, director of campaigns for the UK nonprofit Sense About Science. The group, along with the Cochrane Collaboration, is part of the 'AllTrials' alliance of organizations campaigning for more complete registration and reporting of clinical trials.

But the biggest gain, according to Lane, was the decision by parliament members to accept an amendment that, if made law, would mean that no data generated in a clinical trial can be considered commercially confidential once a marketing authorization has been granted for the intervention in question. “Commercial confidentiality was the biggest argument used by the pharmaceutical industry against transparency,” says Lane, “but that is now part of the clinical trials directive.” (The decision stands in contrast to a 30 April temporary injunction by the General Court of the EU ordering the London-based European Medicines Agency to keep data from two companies confidential, a setback to that agency's attempts to promote the release of information about therapies it has either approved or rejected.)

The European Federation of Pharmaceutical Industries and Associations (EFPIA), a Brussels-based trade group, moved swiftly to voice its concerns that the committee had taken an “unbalanced approach.” In a statement released shortly after the vote it argued that adopting the amendments could “jeopardize patient privacy, the integrity of regulatory systems, and incentives for investment in biomedical research in Europe.” Director General Richard Bergström of the EFPIA stresses that his members are committed to “working to enhance data sharing with researchers and to enhance access to clinical study results after approval in the interests of advancing science and patient health.”

Directive action

The ECTD came into force over a decade ago with the aim of bolstering the protection of trial participants and increasing the quality of research done in the EU. But from the outset, critics pilloried the directive for stymieing research by mandating excessive trial monitoring and endless paperwork; additionally, its legal status as a directive rather than a regulation meant that it was implemented slightly differently in each EU member state, causing a headache in trials conducted at multiple sites across Europe.

“Like many good intentions, the ECDT succumbed to the law of unintended consequences by making clinical trials held in Europe more difficult to do, so naturally led to fewer being done,” says Peter White, a psychiatrist at the Wolfson Institute of Preventive Medicine at Queen Mary University of London. The number of clinical trials started in Europe fell by 25% between 2007 and 2011, and the new regulations are designed to reverse that trend by doing away with some of the ECDT's bureaucratic hurdles. These include the requirement that trials of interventions that are already routinely used in clinical practice be subject to the same burden of regulatory scrutiny and safety data reporting as a first-in-man study of an experimental new drug. In contrast, the new regulations contain provisions for so-called low-risk trials, which would require less regulatory oversight.

The new regulations were taken up by the European Commission amid much fanfare that they would make Europe a more attractive place to do research by slashing red tape and reducing costs. But, in addition, Glenis Willmott, a British member of the Progressive Alliance of Socialists and Democrats political group in the European Parliament and the rapporteur responsible for guiding the proposals through the committee stage, also saw them as an opportunity to address long-held concerns over how trial data are shared.

However, the EFPIA is not alone in voicing concerns about the push toward greater transparency. The current emphasis on transparency is in danger of “derailing the discussion from what we should be focused on,” says Martin Landray, an epidemiologist and trial design specialist with the Clinical Trials Service Unit at the University of Oxford, UK, and one of the organizers of the Sensible Guidelines for the Conduct of Clinical Trials collaboration between trials groups from Oxford, McMaster and Duke Universities, which campaigns for reforms of regulations governing clinical trials. “We need to get back to discussing how to get more studies started and facilitate their conduct,” Landry argues. “Transparency on studies that don't happen isn't very helpful.”