Decentralised Clinical Trials
Activities required to participate in clinical trials can be a significant burden for trial participants. These can include frequent hospital visits, which may include transportation and waiting time. This will be particularly inconvenient for citizens who live far from the relevant research-active hospital departments, creating an inequality of access to clinical research in Denmark.
Decentralisation of clinical trials with medicinal products offers new opportunities to put the citizen (the trial participant) at the center. For example, trial participants can have their medicine sent to them rather than having to pick it up at the hospital or have trial-related procedures, such as blood sampling, performed at or close to home. This means that citizens across the country can access leading research departments much more easily, regardless of mobility and physical distance.
- Today, traditional clinical trials are conducted by taking participants to a hospital for examinations.
- In a decentralised trial, it is no longer as necessary for trial participants to visit the hospital. A decentralised trial can involve, among other things, consultations with the responsible doctor (investigator) taking place via a video connection and blood samples being taken at the participant's home.
Clinical trials with medicinal products are accelerating in terms of digitalisation and decentralisation. This means the use of digital tools (digital consent, electronic consultations, electronic data collection systems, weareables and other medical devices, etc.), which secondarily supports the fact that trial participants are not as dependent on physical access to a hospital as in traditional clinical trials (decentralisation).
This development helps ensure equality in healthcare, as patients can participate in clinical trials regardless of mobility and physical distance to hospitals. This will also ensure a broader representation of trial participants and facilitate the inclusion and retention. Medicine development is also extraordinarily capital-intensive and digital development has the potential to drive down the cost of medicine development for the benefit of both patients and society.
National and EU guidance
In 2020, the Danish Medicines Agency launched a project to ensure an up-to-date and robust regulatory framework for digitisation and decentralisation of clinical trials so that Denmark can maintain a strong position in clinical research for the benefit of patients.
To ensure strong interaction between authorities, patients, researchers and industry, we established a dialog forum in collaboration with Trial Nation. The outcome of the work of the dialogue forum was the national guidance on the subject, which you can find on the right side of this page. The guidance describes how decentralised elements in clinical trials can be used under conditions that ensure safety, data quality and the interests of the trial participants.
The Danish Medicines Agency was the project manager for the EU project on decentralised clinical trials, which published an EU guideline in 2022, which also contains an overview of specific requirements in the individual member states. The Danish Medicines Agency has fully implemented the EU guideline, but in the national guideline you can find further specifications and options for the use of DCT in Denmark.
We refer to the National Center for Ethics for guidance in this area.