European Medicines Agency takes rapid action on missing clinical trial results
- Till Bruckner
- 20 hours ago
- 4 min read
The European Medicines Agency has taken rapid and decisive initial steps to ensure that clinical trial results are made public as required by law.
In a letter sent in response to a recent call by 20 health groups for EMA to address the problem, the agency disclosed that it has already:
Started sending out email notifications to companies and universities when trial results become due
Set up a monitoring system that shows national regulators which of their trials have failed to report results
By the end of the year, EMA will additionally publicly report on the number of published clinical trial results.
Unprecedented speed
Till Bruckner, founder of TranspariMED, said:
“We have never before seen a regulator respond so positively, decisively and rapidly to a campaign. I am delighted that EMA has implemented two of the key measures we proposed with exceptional speed. Hopefully, this will ensure that a far higher proportion of trial results are made public over the coming months.”
“This positive response indicates that the European Medicines Agency deeply cares about clinical trial transparency and is keen to get the new system to work as intended. This is excellent news for patients, doctors and scientists across Europe.”
This is not the first time EMA has responded constructively to transparency concerns related to CTIS. In 2023, after TranspariMED, Prescrire and other health groups challenged plans that could have allowed long delays in the publication of trial protocols, EMA revised its approach and adopted stronger CTIS transparency rules.
Two key gaps remain
EMA’s response left two key demands unaddressed. (Considering the speed of EMA's response, this is not neccessarily an indicator of unwillingness to take action.)
Gap 1: Making compliance data visible on CTIS
Patients should be able to see which trials have reported results as required, and which companies are following the law. Also, citizens should be able to compare how their national medicines agency compares to others in terms of ensuring that all trial results are made public.
EMA’s letter noted that these data are now available to national regulators. Going forward, the public should have access to this information too. Creating a public dashboard would not be technically challenging, but it might be politically challenging as some national regulators may prefer to keep their performance hidden from the public.
Gap 2: Create a quality assurance system for trial results
The academic study that originally sparked the letter identified multiple tragicomical ‘results’ documents that contained vague narratives, redactions, or no results whatsoever, suggesting that regulators were not actually checking what those documents contained.
EMA’s letter flagged a workplan that includes a “Campaign on high quality submission of CTIS data, including summary of results”. While explaining legal requirements to companies and universities is a positive move, it is not a substitute for effective regulatory oversight. (There are speed signs all along European roads - but there are speed cameras too.) Experience from the United States shows that multiple rounds of regulatory reviews are often required until submitted trial results meet basic quality standards.
Putting a system like this into place is clearly feasible – the United States already do it – but will take some time and require additional resources.
First, responsibility for such reviews will have to be allocated, either to EMA or to national agencies. Second, the CTIS system will need to be adjusted to support the review process. Finally, conducting these reviews will require additional staff. (The study noted that the United States invests up to $14.5 million per year into this. While the cost will be equivalent to just a few cents per European citizen, and the value-for-money argument is compelling, that money will still have to be found.)
Patient safety at stake
The call to action was sparked by a recent study finding that less than half of European drug trials had made their results public on CTIS as required by law. Thousands of additional trials on CTIS will become due to report results over the coming months and years.
On 15 June, Health Action International, Prescrire, TranspariMED and 17 other health, patient and transparency groups had written to EMA’s Management Board asking it to address these rapidly growing evidence gaps on the Clinical Trial Information System (CTIS), which contains data on all drug trials run in Europe.
The new European legal framework aims to ensure that patients, doctors, researchers, regulators and systematic reviewers can rapidly access comprehensive information on the safety and effectiveness of medicines. In the past, failures to make trial results public have led to tens of thousands of patient deaths.
What happens next?
TranspariMED and allied groups have written to all 30 national regulators in Europe to ask them about what they are doing to ensure that clinical trial results are rapidly made public as required by law. Most responses are already in.
In parallel, an investigative journalist collaborating with TranspariMED has written to all companies, universities and hospitals that did not make trial results public as required by law to ask them what went wrong, and whether they were contacted by their national regulator about this issue. We have already heard back from multiple sponsors.
After summer, TranspariMED will revisit the issue of a public CTIS dashboard that provides information on who is reporting clinical trial results, and who is not. (We are optimistic that EMA will deliver this, in some form.)
Finally, TranspariMED will track progress towards setting up a quality assurance system ensuring that submitted clinical trial results meet the quality standards set out by law.
The goal is simple: Every clinical trial result should be reported as required by law, and every European patient who volunteers to participate in medical research should be able to trust that the evidence generated by that trial will benefit others.
Copies of the original letter to EMA and EMA's response can be downloaded below.
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