Europe's New Clinical Trials Rules: Questions Remain about Data Transparency

Although a broad compromise was reached in late December on the future shape of the European Union’s clinical trials rules, there are still many details to be resolved – including on that perennial issue of data transparency.

In mid-December, Glenis Willmott, the UK socialist who is piloting discussions on the proposal in the European Parliament, claimed that she had brokered “a historic deal on clinical trial transparency.” The deal would require pharmaceutical companies and academic researchers to upload the results of all their clinical trials to a publicly accessible database, she said.

The apparently all-embracing nature of that requirement immediately struck alarm among many clinical trial executives. Nor was the anxiety assuaged by the emphasis in her statement that resistance would not be accepted. Noting the current legal challenge by two pharmaceutical companies against the European Medicines Agency policy of publishing clinical trial data, Willmott added: “This new regulation will make it crystal clear that companies and non-commercial organizations must make this information available.”

Just days later, EU ambassadors signed up to an agreement endorsing the overall approach – although the details still remain clouded by imprecision, and have now to be formalized in discussions between the EU ministers and the European Parliament. EU health commissioner Tonio Borg welcomed the agreement, which, he said, provides for “more transparency on the conduct and results of clinical trials”.

However, the interpretation of the deal from the European drug industry’s principal association, the European Federation of Pharmaceutical Industries and Associations, was that “the legislators’ approach on transparency respects the need to protect personal patient data and commercially-sensitive information.” The EFPIA statement said the result reflects European and US “commitments towards responsible data sharing with researchers, patients and the general public.” ??The rifts exposed by these conflicting interpretations and ambitions reflect the continuing debate among drug producers, health professionals and patient groups over data access – a debate that has raged across Europe for years now, and which was still producing divergent views as recently as a major workshop in Brussels at the end of November.

That redoubtable organization, the European Forum for Good Clinical Practice, acting as honest broker among differing views, held a meeting dedicated to sharing clinical trial data “in the interest of patients and research.” According to EFGCP’s own account, “no one said that everybody needs to have access to all data.” Patients have a fundamental right to information, but the way the information is structured needs to be handled in a useful way, the summary of the exchanges records.

Ensuring that any process is not only transparent, but scientifically sound and ethically acceptable, is one challenge. Another is making sure that information is provided to bona fide competent researchers in a structured way. “Such detailed technical issues are probably best dealt with by including high-level principles in the Regulation, with the operational details left to guidelines, rather than written in stone,” concluded Ingrid Klingmann, the EFGCP secretary general.

Among the advocates of wide access, Laurène Souchet, Policy Officer of the European Patients’ Forum,  argued that sharing data on clinical trials is a “moral imperative” and that criteria for data sharing should be set independently of companies. Robert Rubens, too, a professor of endocrinology at the University Hospital Ghent, Belgium, dismissed industry arguments for confidentiality. He urged providing ethics committees with fuller information, including raw data from earlier trials when evaluating a protocol, and he insisted that ethics committees should be given the results – whether positive or negative – of the trials that they approve.

Anastassia Negrouk, head of international affairs at the European Organization for Research and Treatment of Cancer, warned against trying to define too closely in legislation how the principle of data sharing should operate, since the format or volume of data will vary according to the nature of the research and the stakeholder making the request. Brendan Barnes, a director of EFPIA, added: “It’s a bit more than format. We have to think about how this is communicated to people.”  Birka Lehmann of the German Federal Institute for Drugs and Medical Devices also cautioned that publication of raw data might not be helpful, and an “unbiased synthesis” might be preferable. It is not feasible for everyone to review raw data, she said.

The divergences stretch beyond what data should be accessible, to include questions over who should be allowed to request access, and for what purpose, and when. Proponents of allowing everyone access at any time are confronted by those who believe some form of qualification for researchers is necessary. Defining what form of qualification, and what might constitute a legitimate study purpose, and at what point data should be released, are continuing to prove difficult. It promises to be an entertaining return to work in January as the European Parliament and EU ministers battle over the fine print of their agreement.