EMA urged to release full clinical trial data upon authorizing Covid-19 treatments

Amid worldwide clamor for Covid-19 medicines and vaccines, the European Medicines Agency is being urged by several international clinical evidence experts – including a key German government agency – to publish all trial data on the same day any product is authorized for use against the novel coronavirus.

In a letter to the European regulator, four country directors from the independent watchdog Cochrane and leaders from Germany’s Institute for Quality and Efficiency in Health Care argued that it is critical to promptly release clinical study reports to support further research and proper medical care. The reports are go-to documents that contain myriad details about the methods and results of a clinical trial.

“The international research community is undertaking coordinated efforts to compile all emerging information on Covid-19 medicines and vaccines to ensure the optimal planning and conduct of research and to inform treatment decisions,” they wrote in their May 14 letter. In addition to the German agency, the letter was signed by directors in France, Ireland, Australia, and Germany for the Cochrane program, which periodically evaluates clinical trial data and presses for greater data disclosure.

“To assess these products further and to accelerate the development of additional products, the fast and full public availability of the information submitted to regulators is of utmost importance. Transparency is also vital to maintain public trust during the crisis. With its established processes, EMA is in a unique position to make a difference in the worldwide fight against the pandemic.”

The missive was sent as the EMA is on the verge of issuing a “conditional” marketing authorization for remdesivir, an experimental treatment from Gilead Sciences (GILD). Last month, U.S. officials issued a press release indicating the intravenous medicine helped seriously ill patients recover faster, although complete results of the study, which was sponsored by the U.S. government, are not yet available.

Meanwhile, the U.S. Food and Drug Administration acted on the information by issuing an emergency use authorization for hospitals. Although the authorization is not equivalent to a standard regulatory approval, the move was seen as an endorsement. But some physicians criticized the lack of available study data, arguing for complete data to make fully informed decisions about patient care.

A National Institutes of Health official has said full study results will be published shortly in a peer-reviewed medical journal. But the controversy has tapped into a larger and long-running debate over clinical trial data transparency, a topic that erupted over hidden side effect information and has now come into sharp relief as the pandemic prompts partial or incomplete release of study data.

The pandemic has fueled a surge of study postings on what are known as pre-print servers, although the papers are not vetted. As a result, experts have cautioned the reports may contain selective outcomes, underreport side effects, or reach inappropriate conclusions. One popular site, MedRxiv, warns that posted papers should not be relied on to guide clinical practice.

The IQWIG, as the Germany agency is known, and the Cochrane researchers argue that only clinical study reports — which are provided by drug makers to regulators as part of the usual approval process — can provide sufficient confidence in the safety and effectiveness of a medicine or vaccine. And they noted the EMA has such a policy in place, although the agency has not yet put it fully into effect.

[UPDATE: Later, an EMA spokeswoman explained the agency had to suspend “proactive publication” of clinical data last year due to Brexit, which forced EMA to move headquarters to Amsterdam from London. Restarting the initiative was delayed again by Covid-19, but she added that “we are exploring a possible phased introduction giving priority to the publication of clinical data underpinning regulatory decisions for medicines and vaccines against Covid-19. Further information will be communicated shortly.”]

The policy was tested earlier this year, though, when the European Court of Justice sided with the EMA in a battle against two drugs makers that claimed greater transparency would come at the expense of their commercial secrets. The EMA maintained certain trial data contained in marketing applications should be made available in the public interest and disclosure would not violate trade secrets, unless a company could justify withholding data.