Clinical Trials of Human Medicines

What is a Clinical Trial of a Medicinal Product?

A clinical trial is conducted to determine how a medicine works, what side effect it may have, and how it is metabolised in the body. The medicines being studied can include both new medicines that are under development, as well as already approved medicines with marketing authorisation in Norway.

Conducting of high-quality clinical trials contributes to knowledge about existing medicines, and forms the basis for the approval of new, effective, and safe medicines.

Definition: Clinical Study and Clinical Trial

Regulation (EU) No. 536/2014 outlines what constitutes a clinical trial. To meet the criteria for a clinical trial, the trial must first fulfil the requirements of a clinical study.

The regulation defines a clinical study as follows:

• To discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products; and/or
• To identify any adverse reactions to one or more medicinal products; or
• To 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 fulfills the criteria for a clinical study (as above), in addition to the following:

• The decision regarding which treatment the patient receives is predetermined and does not fall within standard clinical practice.
• The decision to prescribe the investigational product is made together with the decision to include the subject in the clinical study; or
• Diagnostic or monitoring procedures beyond standard clinical practice are applied to the subjects.

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

• The investigational product(s) have marketing authorisation.
• According to the protocol for the clinical trial:
  • The investigational medicinal product(s) will be used in accordance with the terms of the marketing authorisation, or
  • The use of the investigational medicinal product(s) will be evidence-based and supported by published scientific data on the safety and efficacy of the relevant medicinal products.

and

• Any additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in other Member States.

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

Application Requirements

All clinical trials to be conducted in Norway must first be reviewed and approved by both the Norwegian Medical Products Agency (NOMA) and the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU).

The European Commission has developed a tool to assess whether a clinical trial is subject to application requirements, see Decision Tree (Annex I) in the Q&A document for the regulation. If you are unsure whether your clinical trial requires an application, you can send an inquiry to klut@dmp.no. 

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

Who Can Participate in Clinical Trials?

Clinical trials can include either healthy volunteer participants or volunteer patients, depending on the purpose of the study. All participants must receive both written and oral information about the clinical trial and provide written consent before joining the clinical trial. In certain special cases, specific forms of consent may be given. You can read more about information for participants on the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU) website.

Information regarding ongoing studies in Norway is available on Helse Norge’s webpage.

Approval of Clinical Trials

Clinical trials of medicines must be approved by NOMA and the ethics committee REK KULMU. The sponsor responsible for the study must submit the application using the common European application portal, Clinical Trials Information System (CTIS). NOMA and REK KULMU will evaluate the scientific quality, ethical soundness, and safety of the trial participants.

Monitoring of Adverse Reactions in Clinical Trials

Investigators (physicians or dentists) responsible for conducting a clinical trial at a hospital or clinic must record all adverse reactions in accordance with the study protocol.  If an unexpected adverse reaction occurs, it must be reported to the European Medicines Agency (EMA), which monitors these events. 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.

Clinical trials as Part of the Development of New Medicines

The testing of medicinal products occurs in different phases. Phases I, II, and III typically involve medicines that do not yet have marketing authorisation, while Phase IV trials are conducted after the medicine has been approved. Learn more about the different phases here.