Who Has the Right to See Clinical Trial Data?

October 30, 2019
Peter O'Donnell
Applied Clinical Trials

After a court case rehashes the issue of excessive secrecy in trial data, drug firms maintain their objections over releasing data on their products.

That longstanding concern among European academics and health activists about what they see as excessive secrecy over clinical trial data is back. It has been prompted by a court case that looks as if it may reinforce rather than relax confidentiality of trial results. 

Among a number of current battles in the European Union’s senior court, where the European Medicines Agency is fighting off drug firms’ objections to release of data on their products, one of the court’s principal advisers has suggested that transparency is going too far in one case. If his opinion is adopted by the full court, it could mark the turning of a tide which has been rising for a decade and more.

The case in point is an appeal by PTC Therapeutics International against EMA’s planned release of a clinical study report on its Translarna, an orphan drug to treat Duchenne Muscular Dystrophy. The company maintains that release compromises its commercial interests-particularly since the request for the information came from another pharmaceutical company. In an initial opinion-which still has to be reviewed by the court- Gerard Hogan, the leading Irish judge at the court, considers that disclosure of the report is not without risk to the company’s commercial interests. He noted that the company requesting the data “is or might be a competitor”, and he questioned what has become something of a general presumption by the court that clinical study reports should be disclosed.

A final ruling is not expected until late 2019 or even 2020 (the EU’s court customarily grinds small and slow), but already alarms are being sounded across the continent by advocates of greater transparency. A meeting in the European Parliament in October saw a procession of prominent healthcare activists, academics and politicians highlight the case and spell out what they saw as the risks from a judgement in the company’s favor. Michèle Rivasi, a French Green MEP with no love of the drug industry, insisted, “Public health requires transparency,” and “we, politicians, citizens and patients, cannot accept that clinical studies remain confidential, unreported or subject to trade secrets.”

Karla Soares-Weiser, Editor in Chief at Cochrane Library, which compiles studies for researchers, healthcare professionals, patients and policy makers, said the availability of clinical trial data, “is essential” because without it, “we risk to base our reviews on partial data and to exaggerate benefits of a health intervention or underestimate its possible harms.”  Jaume Vidal of the activist organization Health Action International added: “It is a shared responsibility of all involved to ensure that commercial interests do not jeopardize patient safety-curtailing access to clinical trial data would do just that.” Till Bruckner, the founder of Transparimed, which follows closely (and often critically) the reporting record of clinical trials across Europe, said the court case is “threatening a return to greater opacity.” Ancel.la Santos, senior health policy officer at European consumers bureau BEUC, said “any move that would force EMA to take a step back from its current practice would be extremely regrettable.”

And a press release issued after the parliament meeting noted that “despite the European Commission’s Clinical Trial Regulation to improve transparency and accountability entering into force in June 2014, implementation is being dogged by a lack of commitment from various quarters.”

Even EMA itself is sufficiently concerned for its recent board meeting to note formally that if the court follows the Hogan line of thinking, “EMA’s existing transparency policies would be impaired and have to be revised.” It went on to record that EMA management board members “reiterate that making available to the public most data submitted to the agency for the purpose of marketing authorizations and variations, generates trust in the EU regulatory network, broadens the scientific knowledge base, fosters the development of medicines and ultimately benefits public health.”

The trend for so long has been towards greater release of data that it has become almost axiomatic in Europe that clinical trial reports can no longer be kept from public view. Successive bouts of regulation and legislation have confirmed the direction of travel. But now the court–and in line with the court, the whole of the EU-may have to become rather more precise about defining what is and is not ripe for release.