Clinical trials
A clinical trial is an investigation of the effect of a medicinal product, the adverse reactions it causes and how it is converted in the body. The investigation can comprise both new medicinal products and known medicinal products, which are already on the market in Denmark.
Investigations are carried out on healthy, voluntary trial subjects or on voluntary patients. All persons participating in a clinical trial must be given both written and oral information about the trial, and they must consent to participating before they become part of the clinical trial.
In Denmark, clinical trials must be notified to the Danish Medicines Agency by the person or organisation with the overall responsibility for the trial (the sponsor). In addition to the sponsor, the trial must also have a responsible doctor or dentist. The Danish Medicines Agency evaluates both the quality of the investigation and the patient safety of the clinical trial. Clinical trials must also be notified to a research ethics committee, which primarily evaluates the ethical aspects of the trial. Before a clinical trial may be initiated, both the research ethics committee and the Danish Medicines Agency must approve the trial.
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