Clinical trials of medicinal products
When a new medicine is to be developed, clinical trials with human participants must be carried out to find out how the medicine works, what side effects it has and how it is metabolised in the body. In this short film, you can hear more about how a medicine passes the tests and reaches consumers.
Watch the Danish movie: How a medicine passes the test (click English subtitles in the expanded box)
A clinical trial of medicine takes place in different phases. Phase 1-3 precede the authorisation of the medicine, and phase IV includes trials with known medicines that are already on the Danish market.
Read more about the clinical trial phases.
The Danish Medicines Agency must authorise the conduct of clinical trials of medicines. The application must be submitted by the organisation or person with overall responsibility for the trial, but it must always be a doctor or a dentist who is in contact with the participants in the trial.
Clinical trials must also be notified to a research ethics committee. The research ethics committee primarily evaluates the ethical aspects of the trial as well as the information that is made available to the trial participants. The research ethics committee must authorise the trial as well.
The participants in a clinical trial of medicines must be healthy volunteers or patient volunteers.
Adverse reactions in clinical trials of medicines
The organisation or person with overall responsibility for the trial must collect adverse reactions occurring in the trial and must regularly report Suspected Unexpected Serious Adverse Reactions (SUSARs). Read more about how to report adverse reactions in clinical trials here (in Danish).
Questions and answers
We have compiled some common questions and answers about clinical trials of medicines. Find them here:
Questions and answers – clinical trials in humans
Questions and answers – about clinical trials in general
GCP inspections
The Danish Medicines Agency performs inspections of clinical trials to ensure compliance with the standards of good clinical practice (GCP). Read more about good clinical practice here.
The future
New rules are coming in the area of clinical trials of medicines. The new EU rules are expected to enter into force by the end of 2020.
More information is provided on this page where the European Medicines Agency goes through the new clinical trial regulation.