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Denmark to introduce sanctions for non-reporting of clinical trial results

In Denmark, sponsors that fail to report clinical trial results will soon face fines or even prison sentences, explains Lene Grejs Petersen of the Danish Medicines Agency in this guest blog.

The Danish medicines agency (DKMA) will further step up its efforts to improve the publication of results from clinical trials in Denmark.

In November 2019, DKMA published a statement highlighting that non-commercial sponsors such as universities in Denmark had published the results of only 23.6% of their clinical trials of medicinal products on the European database. The statement reminded these sponsors to “publish all relevant protocols and results of clinical trials”.

To support these efforts, public Good Clinical Practice units developed a manual for researchers on how to upload results onto EudraCT, the European trial registry, as well as supporting information.

DKMA also sent out warning reminders to sponsors (most of them non-commercial) that had failed to make clinical trial results public. This was successful. At year end 2019, a total of 90 due clinical trials in Denmark were missing results. By now, sponsors have already uploaded the results for 30 of these trials.

Under the current legal framework in Denmark, sponsors that fail to report results on time can be fined or given a prison sentence of up to four months.

However, DKMA cannot issue fines by itself. Instead, the regulator has to go through the public prosecutor.

Going forward, DKMA has decided to make use of this legal basis.

We are already planning the process. We have already sent out one reminder to sponsors and if they do not comply, we will look into their case and will act in accordance with our planned procedure.

To clarify responsibilities, DKMA has made clear that it is sponsors’ responsibility to upload their trial results. Sponsors can do this directly. There is no requirement to additionally submit results to the medicines agency, which avoid needless duplication of effort. The sole exception to this rule are Phase I trials; because their results are not made public, they still need to be submitted to DKMA.

We expect that the actions within the existing legal framework that we have taken so far, and will take in future, will lead to a significant improvement in trial reporting. However, we think they will not fully resolve the problem. Therefore, we have formed a taskforce to explore other possibilities. Once we have decided on how to proceed, we will publish details on our website.

Lene Grejs Petersen is a Senior Adviser at the Danish Medicines Agency (DKMA).

For more information on why clinical trial transparency is so important, and what trial sponsors can do to improve their performance, please visit the publications page on the TranspariMED website.

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