Clinical trials - a new dialogue forum

Together with Trial Nation, the Danish Medicines Agency has set up a new dialogue forum focusing on digital developments and the decentralisation of clinical trials regarding medical products.

Digitisation and decentralisation being the new keywords for clinical trials. It means using digital tools, like for instance digital consents and electronic consultations, which entail that trial participants do not have to depend on going to an actual hospital ward (decentralisation) to the same degree as in traditional clinical trials.

The aim of the forum is to share views, problems and experiences with the digitisation and decentralisation of clinical drug trials in Denmark. One of the topics to be discussed is the regulatory requirements, and it will be clarified which procedures that perhaps cannot be carried out within the current framework regarding clinical research in Danish and European law.

The aim being for the forum to secure that authorities, patients, researches and the industry interact in the best possible way.

Industry, CRO, research community, the Danish National Committee on Health Research Ethics, GCP units and patient association representatives have been invited to participate. 

The Danish Medicines Agency intends to publish the knowledge gained through the forum from time to time. 

Additionally, the Danish Medicines Agency plans to run pilot projects regarding the digitisation and decentralisation of clinical trials, and all sponsors are welcome to contact the Agency in this respect.  

In 2021, the Danish Medicines Agency also plans to have open meetings for all interested parties about this. 

Read more about the forum and the pilot projects (in Danish)

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