What are clinical trials?
Clinical trials, or experimental treatments, are studies conducted on humans to investigate the effects of drugs or other treatment methods, but also to investigate how drugs will interact with the body and whether the side effects are acceptable.
The goal of clinical trials is to gain increased knowledge of diseases that can affect us, the types of treatment that can be administered, and which treatment is best.
What the study entails for you, what the researchers are investigating, how surveys and follow-up is conducted, and how long they last – all these factors vary from study to study.
In a clinical trial, researchers may request the right to use information from your patient records, investigate samples taken in connection with your stay in a hospital, or take samples of blood, urine and other biological material from you.
In other cases, you may be asked to take part in trying out new drugs or various forms of treatment, such as a surgical method, special diets or the use of medical technical equipment. In some trials, new drugs are compared with drugs with no effect, also known as placebo.
How to participate in a clinical trial
Participation in a clinical trial is not a right. There are strict requirements for the selection of participants.
In order for you to be considered as a participant in a clinical trial, your attending physician usually needs to submit a request to the hospital responsible for the trial. You also need to fit the criteria that researchers have stipulated for patient selection for their trials. These criteria may, for example, be your:
- test results, such as blood test values
- previous diseases
- current medication
Such criteria are important for your safety and to ensure that the data and results collected are comparable and can provide answers to the questions asked in the trial.
Advantages and disadvantages of participating
If you are considered for participation in a clinical trial, it is important to think carefully about what this will entail. Participating in a clinical trial may require a lot of your time and effort, as trials often involve more controls, tests and samples than normal treatment.
The treatments that you receive during the trial may also have side effects, both severe and less severe. New drugs can cause unexpected side effects. An important part of clinical trials is specifically to chart these. Those responsible for the trial are kept informed of what side effects are detected throughout the process and will, as far as possible, ensure that the side effects are dealt with so that you are not exposed to unnecessary risk.
If you participate in a clinical trial, you may have access to the latest and most advanced treatment before it is publicly available. In the case of so-called randomised trials, you will be assigned a treatment type by drawing lots. The purpose is normally to compare the experimental treatment with the best available routine treatment, i.e. the treatment you would normally receive if not a participating in the trial.
You will be closely monitored by the doctor and nurses who are responsible for the trial. If the new treatment method does not help you, the results of the trial may still help other patients with the same illness – sometime in the future.
Once you have been offered a place on a trial
All those who have been assessed and offered a place on a clinical trial are invited to a meeting with those responsible for the trial. During the meeting, you will receive oral and written information about the purpose of the trial, how long it will last, what samples and tests you may have to take, what positive effect the trial may have, what side effects can occur, and who is responsible for the trial.
You will be asked to sign a statement confirming that you have received information about the trial and would like to participate. This is not a legal contract and you can withdraw from the trial at any time without providing a reason.
Those responsible for the trial may have to perform additional investigations to clarify whether you fill the criteria for joining the trial. If you have any questions, just ask the persons responsible for the trial. It is important that you feel confident that you receive detailed answers to your questions.
Who conducts clinical trials?
A clinical trial often involves several doctors across the country who collaborate. Some of the trials take place in several countries at the same time. A clinical trial of a drug is often carried out in a collaboration between the pharmaceutical company that has developed the drug, and health personnel in hospitals. Trials are governed by strict regulations.
All medical research projects involving humans, biological material from humans or health information require the approval of the Regional Committee for Medical and Health Research Ethics (REK). In addition, all clinical trials involving drugs require approval by the Norwegian Medicines Agency. Clinical trials of medical devices require approval by the Norwegian Directorate of Health.
Clinical trials – Terms and participant rights
If you participate in a clinical trial in Norway, you have the right to withdraw at any time, be informed of any changes in the trial, and more.
Illustration: Viktor Cap / Mostphotos