Norwegian
What are clinical trials?
Clinical studies can be divided into clinical treatment studies and observational studies.
Clinical treatment studies are clinical treatment and rehabilitation studies that can affect the research participants' patient trajectories. The studies are registered in two subgroups:
- Drug studies.
- Studies with treatment measures other than drug treatment (e.g., physical interventions, ionizing radiation, physiotherapy or other type of intervention).
Observational studies are studies where the research participants' treatment pathways are not affected by the study, and the research participants can receive treatment as usual. Data from registers and population studies can be used to include participants in the study. Such data can include biological samples (tissue, blood), images (PET, MRI) etc.
Registration of clinical trials
EU Clinical Trials Register: All drug studies subject to application within the EEA area must be registered in the EU Clinical Trials Register. This is done by the Norwegian Medicines Agency (SLV), which uploads information from the EudraCT form when the study has been approved by both REK and SLV. The European Clinical Trials Database (EudraCT) is a common European database for clinical trials. This registration must be done before commencement and can be done in parallel with an application to REK (Regional Committee for Medical and Health Research Ethics). EudraCT is approved by the ICMJ so that studies registered in EudraCT do not need to be registered elsewhere prior to publication (such as in ClinicalTrials.gov).
ClinicalTrials.gov: Other clinical interventional and observational studies are registered in ClinicalTrials.gov which is a database of privately and publicly funded clinical trials conducted worldwide. In September 2004, the International Committee of Medical Journal Editors published; " The Vancouver Group" for registration of clinical trials. Clinical intervention studies must be registered in ClinicalTrials.gov or in similar databases before commencement (i.e.. before the first participant is even included).