The Danish Medicines Agency has updated its guidance on digital and decentralised clinical trials (DCTs). The update, announced on 9 June 2026, aligns with the common EU guidance while providing supplementary information relevant to the Danish context, including a section on cross-border participation.

According to the Agency, the Danish guidance does not introduce any additional requirements beyond the EU framework.

Decentralised Clinical Trials: Putting Participants at the Centre

The Danish Medicines Agency highlights that activities required to participate in clinical trials can represent a significant burden for trial participants. Frequent hospital visits may involve transportation and waiting times, which can be particularly challenging for individuals living far from research-active hospital departments. This may contribute to inequalities in access to clinical research in Denmark.

Decentralisation of clinical trials involving medicinal products offers opportunities to place citizens and trial participants at the centre of the research process.

Examples described by the Agency include:

• Trial participants having medicinal products sent directly to them rather than collecting them from the hospital.
• Trial-related procedures, such as blood sampling, being performed at or close to the participant's home.
• Consultations with the responsible investigator taking place through video connections.

According to the Agency, these approaches enable citizens across the country to access leading research departments more easily, regardless of mobility limitations or geographical distance.

Traditional Versus Decentralised Trials

The Danish Medicines Agency contrasts traditional and decentralised trial approaches:

• In traditional clinical trials, participants attend hospitals for examinations and study-related activities.
• In decentralised clinical trials, hospital visits may become less necessary, with certain activities being conducted remotely or closer to the participant's home.

Digitalisation Supporting Decentralisation

The Agency notes that clinical trials involving medicinal products are accelerating in terms of both digitalisation and decentralisation.

Examples of digital tools include:

• Digital consent
• Electronic consultations
• Electronic data collection systems
• Wearables
• Other medical devices

These technologies support decentralisation by reducing participants' dependence on physical access to hospitals.

Potential Benefits of Decentralised Clinical Trials

According to the Danish Medicines Agency, this development may contribute to:

• Promoting equality in healthcare by enabling participation regardless of mobility and distance from hospitals;
• Ensuring broader representation of trial participants;
• Facilitating participant inclusion and retention; and
• Supporting medicine development, where digital approaches may have the potential to reduce development costs for the benefit of both patients and society.

National and EU Guidance

In 2020, the Danish Medicines Agency launched a project aimed at ensuring an up-to-date and robust regulatory framework for the digitalisation and decentralisation of clinical trials, supporting Denmark's position in clinical research for the benefit of patients.

To strengthen collaboration among authorities, patients, researchers, and industry, a dialogue forum was established in partnership with Trial Nation. The outcomes of this dialogue contributed to the development of national guidance describing how decentralised elements can be used in clinical trials while ensuring:

• Participant safety;
• Data quality; and
• Protection of trial participants' interests.

The Danish Medicines Agency also served as project manager for the EU project on decentralised clinical trials, which resulted in the publication of an EU guideline in 2022. The EU guideline includes an overview of country-specific requirements across Member States.

The Agency states that it has fully implemented the EU guideline. However, the Danish national guidance provides additional specifications and options regarding the use of decentralised clinical trial elements in Denmark.

The updated Danish guidance additionally includes supplementary information relevant to Denmark, including a section addressing cross-border participation.

Ethics Guidance

For guidance related to ethical considerations in decentralised clinical trials, the Danish Medicines Agency refers stakeholders to the National Center for Ethics.

Change Log

The Danish Medicines Agency notes the following update:

• 9 June 2026: Updated Danish DCT Guideline Version 3.0.

For more information: The guidance on digital and decentralised clinical trials (DCT) has been updated

Supporting Modern Clinical Research

As decentralised and digitally enabled clinical trial models continue to evolve, organisations involved in clinical development may need to adapt operational approaches while maintaining participant safety, data quality, and regulatory compliance. Baupharma's Clinical Research services support sponsors throughout clinical trial activities, helping teams navigate changing research environments and evolving study models.