Guidance on the implementation of decentralised elements in clinical trials with medicinal products is now available

Decentralised clinical trials with medicinal products meet the patients, wherever they are, in a faster and more efficient process benefitting both patient, healthcare professionals and industry.

It is therefore gratifying to be able to announce that another important milestone has been reached in the Danish Medicines Agency's project to ensure an up-to-date and robust regulatory framework for decentralisation of clinical trials.

This is the publication of the written guidance, which provides regulatory insights into opportunities and challenges of decentralisation. It is important to emphasize that this is the first edition of the guidance and it is expected to be continuously updated once new knowledge is gained and solutions found for the challenges in question.

Late last year the Danish Medicines Agency, in collaboration with Trial Nation, established a Danish dialogue forum focusing on decentralisation of clinical trials. This initiative facilitate knowledge sharing between authorities, patients, researchers and industry. The Danish guidance on decentralised clinical trials reflect knowledge accumulated in the forum and is in addition the focal point for the Danish Medicines Agency's efforts in the European initiatives within the area. We therefore encourage all stakeholders to send comments, input or questions to the inbox for clinical trials, which will help to further develop the framework of conducting decentralised clinical trials.