Universities across Finland, Norway and Sweden have failed to upload the results of hundreds of clinical trials onto the EU Clinical Trial Register, in violation of EU transparency rules.
This is not a victimless crime.
Research whose results remain hidden benefits nobody, and makes no contribution to the discovery of new treatments and cures. Taxpayers’ money is wasted, trial participants’ trust is abused, and public health resources can be misallocated on a huge scale.
HELP NEEDED: TranspariMED has repeatedly contacted journalists in Scandinavia about this problem, without success. If you know any journalists looking for a good story, please send them a link to this blog. TranspariMED can assist them with further research.
Universities sometimes argue that they report all trial outcomes in academic journals, but this is not the case. For example, a recent study by the BiH QUEST Center identified 433 trials run by German universities that aimed to recruit 56,730 patients and whose results remain completely invisible (see also page 6 onwards here).
In addition, publication in journals alone falls significantly short of scientific excellence.
Using the EU Trials Tracker, TranspariMED took a quick look at some universities in Scandinavia. The data is accurate as of end January 2020. What we found calls into question the narrative of Nordic excellence in scientific research and transparency. Click on the images below for more detail.
University of Oslo – 98 trials, zero results posted
University of Helsinki – 111 trials, five* results posted
* Note: This includes the result for one trial that is listed as 'ongoing'.
Karolinska Institute – 212 trials, two results posted
Other universities in Scandinavia also perform badly – type your university’s name into the EU Trials Tracker search window to discover its performance.
Many academic institutions in other countries perform far better. For example, University College London and King’s College London have both already reported 100% of due trial results, as has University College Dublin in Ireland. Mario Negri Institute in Italy has already reported over 87% of its results and is continuing to add more.
Scandinavian universities’ record is even worse than it looks
Sadly, even the disappointing percentages of due results available shown in the charts are gross over-estimates because the EU Trials Tracker bases its figures on registry records. A closer look at registry data shows that dozens of trials still listed as ‘ongoing’ were probably completed many years ago.
For example, if you click on the Tracker entry for University of Oslo, and then click on the tab “not due”, you can see 14 trials that began in 2009 or earlier and are still listed as ‘ongoing’, which is not plausible. A further nine trials have “inconsistent data”.
When a trial has ended, universities have to notify their national regulator, which then updates the trial status on the registry. Therefore, in the case of false “ongoing” trials, it is not possible for outsiders to determine whether the university or the regulator failed to perform its duty.
In an email, a representative of Norway’s regulator conceded that “In some of the cases it might be that the Norwegian Medicines Agency has not updated all need information… in order to answer you properly, we need to check what is needed is each clinical trial.” (sic)
Reactions from Norway
Norway’s regulator explained in an email that:
“Concerning publication of results from clinical trials, we are frequently in contact with researchers and Sponsors. In particular we teach at GCP-courses at different universities in Norway. In these presentations we talk about publications of results and how this is regulated in EU and in Norway.
As you are aware of, publication of results is described in EU-guidelines, but it is important to be aware that publication of results in the Clinical Trials Register (CTR) is not an obligation in the Norwegian Regulation for Clinical Trials. Having that in mind, we are not in a position to force Sponsors to publish results in the CTR, but we give speeches, and encourage to do so.”
University of Oslo press office stated that:
"UiO has uploaded to EudraCT in cases where we are the sponsor.
"Reporting of final reports to the EU Trials Register has not been implemented as a requirement in the Norwegian Regulation for Clinical Trials of Medicinal Products, nor has The Norwegian Medicine Agency informed about this requirement on their webpage for Clinical Trials. [cites link and link]
"In the Quality Assurance system for Health and Medical Research at University of Oslo, there is a separate procedure for Clinical Trials which requires submitting a final report to the Norwegian Medicine Agency and Regional Committee for Medical and Health Research Ethics. [cites link and link]
"We have informed the Principal Investigators for Clinical Trials at University of Oslo of the requirement to submit final reports in Eudract/EU Trial Register as well to the appropriate Norwegian Authorities."
Following publication of this blog, the press office added that:
"We would like to emphasize that Norway is not a member of the EU, and that Norwegian law at the moment does not require the uploading of clinical trial results onto EudraCT. However, the University of Oslo and the Norwegian Medical Agency both encourage submitting final reports to the Eudract/EU Trial Register."
Silence from Finland and Sweden
UPDATE: Ole Petter Ottersen, President of Karolinska Institutet, has responded to TranspariMED's blog on Twitter:
"Yes, this is something we are discussing at KI now, there are clearly improvements to be made."
TranspariMED has repeatedly contacted the University of Helsinki and Karolinska Institute, as well as the national regulators in Finland and Sweden. So far, none of these actors have provided a formal response.
If and when they do resapond, their responses will be added to this blog post. Please visit this page again to discover what they say.
Universities can find more information about EU transparency rules and WHO best practices, plus useful slides, tools and case studies to assist them in improving their performance, on the TranspariMED website.