What are clinical studies?

The aim of clinical studies is to increase knowledge about diseases, what types of treatments can be provided, and which treatment is the most efficient.

What being included in a clinical study means for you, how the study is carried out, and how long the study lasts will vary from study to study.

In a clinical study, researchers may ask for your permission to use information from your medical record, examine samples taken during your hospital stay, or take samples of blood, urine or other biological material from you.

In some cases, you may be asked to take part in testing new medicines or different types of treatment, such as a surgical method, special diets, or the use of medical devices. In some studies, a new treatment is compared with a “mock-treatment”, also known as placebo.

How to take part in a clinical study

Taking part in a clinical study is not a right. Strict requirements apply to who can be selected to participate.

To be considered as a participant in a clinical study, your doctor will normally need to send a referral or enquiry to the hospital responsible for the study. You must also meet the criteria set by the researchers for selecting participants. These criteria may include, for example, your:

• diagnosis
• age
• test results, such as blood test values
• previous illnesses
• current medication

Such criteria are important for your safety and to ensure that the data and results collected can be compared and provide reliable answers to the research questions.

Advantages and disadvantages of taking part

If you are requested to take part in a clinical study, it is important that you carefully consider what this will involve. Taking part in a clinical study may require a significant investment of time and effort, as studies often involve more check-ups, tests and samples than standard treatment.

The treatment you receive in the study may also cause side effects, both serious and less serious. New medicines may cause unexpected side effects. An important part of clinical studies is to identify such effects. Those responsible for the study are kept informed of side effects identified during the study and will, as far as possible, ensure that they are managed so that you are not exposed to unnecessary risk.

By taking part in a clinical study, you will receive a new treatment that is not yet available as standard treatment. The amount of information we have about the safety and effectiveness of the treatment depends on the phase of the study.

The patient’s health and safety are always the highest priority for healthcare professionals, also in clinical studies. Therefore, you can be confident that you will be well cared for when taking part in a clinical study.

In randomised studies, the type of treatment you receive is decided by chance. The purpose is usually to compare the experimental treatment with the best available standard treatment – that is, the treatment you would have received if you had not taken part in the study.

You will receive close follow‑up from the doctor and nurse responsible for the study. Even if the new treatment does not help you, the results of the study may help other patients with the same condition in the future.

When you are offered participation

Everyone who has been assessed and offered participation in a clinical study will be invited to a meeting with those responsible for the study. You will receive both verbal and written information about the purpose of the study, how long it will last, which tests and examinations you may undergo, possible benefits, potential side effects, and who is responsible for the study.

You will be asked to sign a declaration confirming that you have received information about the study, understand the content, and that you agree to take part. This is not a legal contract, and you may withdraw from the study at any time without giving a reason.

The study team may also carry out additional examinations to determine whether you meet the criteria for participation. If you have any questions, do not hesitate to ask those responsible for the study. It is important that you feel confident you are receiving clear and thorough answers.

Who conducts clinical studies

Clinical studies often involve collaboration between hospitals across Norway. Some studies are conducted in several countries at the same time. Clinical testing of medicines is often carried out in collaboration with the pharmaceutical company that has developed the medicine and healthcare professionals in hospitals. All studies are conducted in accordance with strict regulations.

All medical research projects involving people, biological material from people or health data, and that are regulated under the Norwegian Health Research Act, must be pre-approved by the Regional Committee for Medical and Health Research Ethics (REK). All clinical studies involving medicines must also be pre-approved by the Norwegian Medicines Agency. This also applies to clinical studies of medical devices.