After more than a year of haggling, European regulators have finalized guidelines for drug makers that want to redact trade secrets from published clinical trial data. And the rules are receiving a cautious reaction.
The move follows protracted debate over trial data transparency, which has been a controversial issue following several scandals over safety or effectiveness data that was not publicly shared.
For years, drug makers have argued that releasing certain data would not only compromise patient privacy, but also harm their competitive standing. Conversely, researchers have responded that without access to specific data, trial results cannot be easily duplicated, which inhibits greater understanding of how medicines might work.
And so, the European Medicines Agency guidance, which was released earlier this month, details how drug makers should submit clinical studies reports, which are documents spelling out study methods and results. In particular, the guidance requires companies to justify when they want to withhold “confidential commercial information,” by explaining how their economic interests would be harmed. But some say the EMA doesn’t go far enough.
Some companies have used “fearmongering about confidentiality to create a stalemate with the European regulator. EMA’s new guidance might now put an end to that stalemate,” said Tracey Brown, who heads Sense About Science, in a statement. The United Kingdom-based organization spearheaded a campaign called AllTrials to pressure drug makers to widen access to trial data.
“But the definition of what is commercially confidential has been hard to pin down, not least because some in the sector want it kept broad,” she continued. “So we urge the EMA to look very closely at how companies start applying these exemptions.”
European Ombudsman Emily O’Reilly, who has sparred with the EMA over its policy, similarly had mixed views. “Increased transparency, according to this document, will be realized through the release of information on secondary endpoints, protocol amendments, statistical methods, and safety-related information, such as adverse reactions,” a spokeswoman wrote us.
However, O’Reilly also expressed reservations about the extent to which confidential commercial data may be released. This is because the EMA effort to improve transparency was mired in controversy, as well, after the regulator released a draft version of its guidance two years ago.
At the time, O’Reilly questioned whether the EMA backtracked on some previously expressed commitments to greater transparency after settling a lawsuit brought by AbbVie. The drug maker had gone to court to prevent the EMA from releasing trial data about its best-selling Humira rheumatoid arthritis medication. And certain data was subsequently redacted.
O’Reilly is finalizing her inquiry into the episode and hopes to release an analysis before the end of April. “We are still examining if all of the concerns were fully dealt with,” her spokeswoman wrote us.
Meanwhile, another advocate of wider access to trial data predicted the guidance will set a bar for other regulators, but also cautioned that questions remains about how the agency will handle redactions for individual patient data. Drug makers have regularly cited privacy concerns as another reason for withholding information.
A future phase of EMA policy is expected to address standards for anonymous patient-level data, and an industry trade group is pushing a stringent approach to redaction, according to Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy. He is also an associate editor at BMJ, which also worked on the AllTrials campaign.
“So it remains unclear whether EMA is going to take a strong stance against approaches that would render individual patient-level data useless,” he said.