Clinical trials with medicinal products

Conducting well-designed and safe clinical trials is essential for building knowledge about medicines and is a key part of approving new, effective and safe medicines. In addition, clinical trials play a vital role in creating an attractive and competent environment for pharmaceutical development and research in Denmark. Clinical trials provide early insight into new medical treatments in the healthcare system, which builds competence and most importantly benefits patients by giving them quick access to new innovative treatments. Our Clinical Trials Unit is dedicated to improving the clinical trial framework in Denmark and the EU in collaboration with stakeholders from across the ecosystem, always with the best interests of patients in mind. Our focus is to deliver timely and high-quality reviews while developing guidance to support the conduct of clinical trials of the future. You can read more about what a clinical trial is here.

Denmark must be in the lead in early phase research

We have an eye for the entire pharmaceutical development process, but believe that Denmark has the potential to excel in the development of new trial designs, trials with more complex medicines related to rare diseases or personaliced medicines, and early phase research, including 'First in Human' (FIH) trials. This is partly due to Denmark's skilled and specialised researchers and Denmark's many technological opportunities. Early phase trials give Danish patients access to the latest therapies and builds a crucial knowledge capacity among both authorities and researchers. This is expected to have a knock-on effect in the later phases of pharmaceutical development. We are continuously working on initiatives to support early research. We have strong capabilities to support the transition from toxicology studies to clinical trials and offer scientific advice on toxicological, clinical and regulatory issues. In addition, work is underway to re-establish the expedited review of phase I trials under the Clinical Trials Regulation.

The Danish experience makes a difference in Europe

We have a high level of representation and activity in working groups under the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). In 2024, we have special focus on implementation/optimization of processes under the new EU regulation and the interface between the development of medical devices and medicines.

Increased focus on non-reporting, including trial completion and publication of results

In 2023, we highlighted non-reporting in clinical trials with a stringent process for reminders that can ultimately lead to a police report. Fortunately, there was no need to do so, as we managed to rectify the cases through dialog with the sponsors who failed to make the legally required reports. There has been a significant improvement and we will continue this focus in 2024 to ensure patient safety and transparency of trial results, which is critical for both the research community and patients.