Questions and answers about clinical trials
What is a clinical trial?
A clinical trial is a study of the effects of a drug or treatment method on humans. The study is conducted as a collaboration between healthcare professionals and the pharmaceutical company that developed the drug.
How is a clinical trial conducted?
This varies from study to study. All studies are conducted according to strict requirements that are the same all over the world. Sometimes the effect is compared between a well-known treatment method and a new preparation, other times between a placebo (a pill with no effect) and a new preparation. Some studies are conducted by many different investigators around the world, while others are only done in a single country. Some studies last for a few weeks, while others last for several years.
Are the studies guaranteed by the authorities?
The studies we participate in are carefully planned and conducted according to a protocol that has been approved and recommended in advance by the Norwegian Medicines Agency and a research ethics committee.
Why are clinical trials conducted?
In order to obtain the safest and most effective medicines and treatment methods possible, it is important that they are tested under controlled conditions. That is why clinical trials are conducted. It is also a requirement from the authorities that a clinical trial must be completed before a medicine can be approved.
What information am I entitled to when participating in a clinical trial?
Those working on the study should thoroughly explain what the study is about and what it means for you to participate, both the advantages and disadvantages. You should have the opportunity to read through written information about the study in advance, and have the opportunity to ask questions. If any new information about the drug or treatment method becomes available during the study, you should be informed about this.
Are there any major risks involved in participating in a clinical trial?
There should be as little risk as possible when participating in clinical trials. The drugs and treatment methods that are tested in a clinical trial have previously been tested in other contexts. Before trying something on humans, it is tested on animals to test its effectiveness and safety. However, there are some differences between humans and animals, so the reaction will not always be the same.
Clinical trials are divided into different phases. In the early phases of a study, studies are conducted on a small number of healthy subjects for a short period of time. Then, the effect is studied on a larger group of patients. Whether it is an early or late phase of the trial is well informed in advance of the study.
What rights/obligations do I have?
Participation is voluntary, and you have the right to withdraw from the study at any time without having to give a reason. However, it is advisable to discuss discontinuation of the study with the trial personnel in advance. You have the right to correct information, and to contact the trial personnel at any time during the study.
It is important that you attend all visits and that you carefully follow the instructions from the trial staff. Therefore, it is important that you let us know if you cannot attend, if you are undergoing other treatment, or if it has not been possible to follow any of the instructions.
What benefits does this have for me and do I get paid to participate?
Usually, you are not paid to participate in a clinical trial. What the project participants in our studies see as advantages of participating is that you usually receive free study medication and follow-up of your health condition. Many see their participation as an important contribution to the development of new and better drugs.
Are the trial personnel bound by confidentiality?
You are protected by the same confidentiality obligation as other patients in the Norwegian healthcare system. This means that only trial personnel have access to information about you that can be linked to your identity.
What protections do I have if something were to happen?
The responsible physician, importer or pharmaceutical company is obliged to ensure that the project participants are financially protected if something should occur in connection with the study. The insurance is taken out by the pharmaceutical company, importer or responsible physician through membership in the Norwegian Drug Liability Association. The injured party shall be compensated regardless of whether fault has been shown.