Clinical trials of the future place the patient at the centre
In many cases, participating in a clinical trial is a considerable burden for the trial subjects. Clinical trials often involve many hospital appointments with a lot of travel and waiting time. The people who are affected the most live far away from the hospital departments concerned, with resulting unequal access to clinical research in Denmark.
Clinical trials of medicines have made rapid advances when it comes to digitalisation and decentralisation. By this is meant the use of digital tools (digital consent, electronic consultations, electronic data collection systems, wearables and other medical devices, etc.), which means that the same degree of physical attendance at a hospital department, as we know it from a traditional clinical trial, is not required in a decentralised clinical trial.
This development helps ensure equality in the health service because it allows people to participate in clinical trials, regardless of their mobility and the physical distance to the hospitals. This will also ensure a wider representation of trial subjects as well as facilitate the recruitment and retention of patients in clinical trials.
How we work with the decentralisation of clinical trials
The Danish Medicines Agency wishes to support this development and has therefore started a project with the aim of ensuring a contemporary and robust regulatory framework for digitalisation and decentralisation of clinical trials so that Denmark can maintain its strong position in clinical research for the benefit of patients. To ensure strong interactions between authorities, patients, researchers and the industry, we and Trial Nation have set up a forum for dialogue, which puts focus on various decentralisation elements.
Right now, we are investigating how to make the many possible decentralisation elements available in safe settings in a manner to safeguard safety, data quality and the interests of the general public. While our efforts have a national scope with plans for issuing Danish guidelines, we will prioritise using our international collaboration agreements and participating in European initiatives.You can read more about the project on our website. If you have input or questions of any kind, please do not hesitate to contact project manager Frederik Grell Nørgaard. Please also note that we encourage applicants to seek regulatory scientific advice before submitting an application for a decentralised clinical trial.