End of trials with medicinal products and reporting of results

To ensure patient safety and transparency in trial results, the Danish Medicines Agency maintains a continuous focus on ensuring compliance with the legal reporting requirements for the end of clinical trials with medicinal products and the reporting of results. This includes a thorough reminder process to ensure dialogue with sponsors, while also highlighting the legal consequences of non-compliance. This means that serious breaches of reporting obligations may lead to police involvement.

Trials approved under the Clinical Trials Regulation

For trials approved under the regulation, sponsors must notify the respective member states of the trial's end no later than 15 days after its completion. Notification is made through CTIS.

When the trial ends globally, all member states must be notified no later than 15 days after the trial's end.

Further details can be found in Question 10.12 in Volume 10 Q&A.

In the GCP unit's guidance, more information can be found on how to make notifications in CTIS.

Within one year of global end of trial, a summary of the trial results must be published in CTIS in accordance with Annex IV of the regulation. A lay summary in accordance with Annex V of the regulation must also be published.

If necessary, the Danish Medicines Agency may request the full report.

In the GCP unit's guidance, more information can be found on how to upload results in CTIS.

Trials approved under the Clinical Trials Directive

For trials approved and ended under the directive, sponsors must notify the Danish Medicines Agency of the end of trial no later than 90 days after its completion. This is done by completing this form and submitting it to our Clinical Trials Unit.

If it is a multinational trial, the Danish Medicines Agency must be notified when the trial ends in Denmark. When the trial has global end of trial, the aforementioned trial end form should be used.

For trials approved under the directive, a summary of the trial results must be entered into EudraCT no later than 1 year after the end of trial. The data will then be automatically published on clinicaltrialsregister.eu within 14 days. This replaces the requirement to submit trial results to the Danish Medicines Agency unless it concerns phase I trials. If necessary, the Danish Medicines Agency may request the full report.

Phase I trials are not published on clinicaltrialsregister.eu unless they involve children. Therefore, publications for phase I trials must still be submitted to us.

Further information can be found in the EMA's Frequently Asked Questions on trial conclusion and results in EudraCT and EU CTR, as well as 'Result related documentation' showing the functionalities of the EudraCT database.

More details can be found in the European Commission's letter to stakeholders on trial conclusion. The GCP unit has also produced user-friendly guidance.

Approved trials concluded without including trial participants

If a trial is approved and ended before including trial participants, a PDF document describing the reason for the end must be uploaded. This process is described in Section 70 of the aforementioned EMA Frequently Asked Questions.

Specifically, for pediatric trials

For pediatric trials where a Pediatric Investigational Plan (PIP) has been prepared, the trial results must be entered into EudraCT within six months.

A PIP must be prepared when planning a marketing authorisation for a new medicinal product, a new indication (including a pediatric one), a new pharmaceutical form, or a new route of administration for an existing medicinal product.

This is in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for pediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83, and Regulation (EC) No 726/2004, which entered into force on 26 January 2007.

Change log: Updated in accordance with CTR