2.03 Use of non-intervention studies
A non-intervention study is a scientific study where one or more doctors monitor one or more patients being treated with the same drug. During this monitoring process, no »medical intervention« takes place. Thus, the doctor does not change the treatment or his/her treatment behaviour, makes no surgical intervention or takes any blood samples apart from samples normally taken in connection with the treatment concerned, etc.
Non-intervention studies are not subject to any reporting obligation (except for the general obligation to notify the Danish Data Protection Agency), nor to any supervision by the Danish Medicines Agency, the scientific ethical committees or any other authority.
Besides, the GCP directive (see ”Position 2.03”) entails that it is not possible to introduce a mandatory obligation to report non-intervention studies to the Danish Medicines Agency.
Lif has therefore urged the Danish Medicines Agency to establish a voluntary system for reporting of non-intervention studies. If an enterprise chooses to report a non-intervention study, the Danish Medicines Agency shall assess whether the specific study is to be considered a non-intervention study and whether it complies with the existing advertising rules, including in particular the fees paid to the doctors conducting the non-intervention study.
Lif believes:
- that non-intervention studies contribute valuable knowledge about the clinical practice in patient treatment,
- that a voluntary system for reporting of non-intervention studies should be established,
- that in the absence of a voluntary system for reporting, the enterprises should submit a description of specific non-intervention studies to the Danish Medicines Agency to have confirmed that the Agency agrees that they are indeed non-intervention studies,
- that the enterprise at the same time asks the Agency to assess whether the study complies with the existing advertising rules.
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