Clinical Trials of Human Medicines

A clinical trial is conducted to determine how a medicinal product works, what side effects it may cause, and how it is metabolised in the body. The medicinal products being investigated may be new drugs that are under development or drugs that are already approved and in use.

Clinical Study vs. Clinical Trial

Regulation (EU) No. 536/2014 defines a clinical study as any investigation involving humans that aims to:

• discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products
• Identify any adverse reactions to one or more medicinal products
• Study the absorption, distribution, metabolism and excretion of one or more medicinal products with the objective of determining the safety and/or efficacy of those medicinal products.

A clinical trial meets the above criteria for a clinical study, in addition to the following:

• the decision on which treatment the patient receives is determined in advance and does not fall within normal clinical practice
• the decision to prescribe the investigational medicinal product is taken together with the decision to include the subject in the clinical study, or
• the diagnostic or monitoring procedures for the subjects go beyond normal clinical practice

A clinical trial is defined as a low-intervention clinical trial if it meets all of the following criteria:

• The medicinal product(s) have marketing authorisation.
• according to the protocol of the clinical trial, the investigational product(s) are used in accordance with the marketing authorisation, or their use is evidence-based and supported by published scientific data on safety and efficacy
• the diagnostic or monitoring procedures pose no more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice.

Non-interventional studies assess health outcomes in a group of patients receiving standard treatment.

Approval of Clinical Trials

Clinical trials of medicinal products must be approved by NOMA and the ethics committee REK KULMU. The sponsor (the person or organisation responsible for the study) must submit the application via the Clinical Trials Information System (CTIS). NOMA and REK-KULMU will assess the scientific quality, ethical justification, and the safety of the participants.

How to determine if your study is a Clinical Trial

The European Commission has developed a tool to help determine whether a clinical study is subject to mandatory application; see the decision tree (Decision Tree) in Annex I of the Q&A document to the Regulation.

If you are unsure whether the study requires an application, you can send an inquiry to klut@dmp.no.

For the assessment of application requirements of non-interventional studies, please contact the Regional Committees for Medical and Health Research Ethics (REK).

Who Can Participate in Clinical Trials?

Clinical trials may include patients or healthy volunteers, depending on what is being investigated. All participants must receive written and oral information and must give written informed consent before joining the clinical trial.

Information on ongoing clinical trials can be found on Helse Norge’s website and the EMA Trial Map.

Monitoring of Adverse Reactions in Clinical Trials

Investigators (physicians or dentists) responsible for conducting a clinical trial must record all adverse reactions in accordance with the study protocol.  If an unexpected serious adverse reaction occurs, it must be reported to the European Medicines Agency (EMA) via the Eudravigilance portal. You can read more about adverse reaction management in clinical trials on our website.

Inspection of Clinical Trials

NOMA conducts inspections of clinical trials to ensure that they are carried out in accordance with the approval granted and the guidelines for Good Clinical Practice (GCP). NOMA performs inspections of clinical trials involving medicinal products both in Norway and abroad, including through the European Medicines Agency.

You can read more about GCP inspections on our website (only in Norwegian).     .