Facts about clinical research
Clinical studies with research/test subjects are important for progress in medical research and helping people to have better health. At the same time, risks for participants must be minimised. The researcher is responsible for those people involved, both for their well-being and for the information that is collected, which is regulated by laws and ethical guidelines.
A research subject is a person who participates in a clinical research study. A research subject may also be known as a test subject, but the definition of a research subject has a wider meaning since clinical research is not always organised in clinical trials or experiments but may also be observational studies or surveys.
Research subjects are usually divided into two groups:
- A patient is a person who has a diagnosis and is suffering from a disease
- A healthy research subject is a person who is not suffering from any disease
Healthy research subjects may be included in studies where we want to examine whether there are differences between healthy people and people diagnosed with a certain disease. Research subjects are also used to try out new pharmaceuticals, and may in addition undergo minor surgery or psychological trials. In some studies, research subjects answer questions about their living habits.
Being a research subject is a voluntary choice, and you can choose to stop participating in a research study at any time without giving any reasons. There is a strong legislation in Sweden to protect research subjects.
Clinical research is carried out to obtain new treatments that are as effective and safe as possible within the healthcare sector. It has enabled us to develop new drugs, different methods of treatment and medical-technical products that we now take for granted.
Researchers use clinical trials in clinical studies to examine the effects of a drug or evaluate a surgical method, psychological treatment, radiation therapy, physiotherapy, nutrition or medical-technical equipment. Research may also be about how the body works, human behaviour and habits, and so on.
There are clinical trials directed solely at healthy people or studies for people with specific diagnoses, and sometimes people are needed from both groups.
Path to approved drug
Under normal circumstances, it takes about twelve years and costs hundreds of millions SEK to test, develop and approve a new drug. The most promising substances are selected first and tested in a research laboratory. All drugs must undergo animal studies before they can be given to research subjects. Clinical trials are subsequently carried out on voluntary research subjects in four phases.
- Phase 1 studies are made on a few healthy volunteer research subjects to see if the drug is tolerated by people and to get an idea of the appropriate dose. Fertile women are not usually included in this group.
- Phase 2 studies are conducted on a small, homogeneous group of patients to find out whether the drug has a positive effect in the treatment of a disease or any adverse effects or other risks. The research subjects often have a very similar disease and may not take other drugs. This group includes both men and women.
- Phase 3 studies are carried out on larger and slightly more varied patient populations. During this phase the trialled drug is compared with the current standard treatment for a longer period of time. If there is no other standard treatment, the drug is tested against a placebo. This group includes men, women, and sometimes special groups such as elderly people and children.
- After Phase 3 the pharmaceutical company may apply for their drug to be approved. When the product is on the market, Phase 4 studies continue to ensure that no serious, unexpected adverse reactions appear.
Thinking about becoming a test subject?
All clinical trials are carried out in accordance with strict rules and are carried out in compliance with a trials plan, reviewed and approved by the relevant authorities. Before you decide if you want to participate in a clinical study, you will be given both oral and written information on the trial, and you will have the opportunity to ask questions.
When you participate in clinical research, you have the same protection of privacy as all other patients in Swedish healthcare. The company, university, hospital, and MD in charge of a clinical research study have extensive obligations under the legislation in force.
By participating in a clinical trial, you will be contributing to the development of new drugs and treatments which can help yourself and others, now and in the future. However, you are entitled to cancel your participation at any time – and you do not need to explain why you do not want to continue.
The website kliniskastudier.se has accurate information in English about clinical trials in Sweden.
For those who read Swedish, the website also has specific information for participants in clinical studies.
The Helsinki Declaration
The method of carrying out clinical research today is based on the Helsinki Declaration. The Declaration, adopted by the World Medical Association in 1964 and updated over the years, provides ethical guidelines for research on humans in the biomedical area.
It prescribes that it is the duty of doctors to constantly improve treatment and broaden our knowledge of diseases, but this must not take place at the expense of individuals' integrity or safety. Trials must be designed in such a way that the risk to participants is no greater than the benefits, and they must be so well-planned that it is possible to answer the scientific question being asked.
Information for KI researchers
Clinical trial registration and reporting at Karolinska Institutet
KI has centralised the process for registering and reporting results for clinical trials and clinical studies. The Compliance and Data Office (CDO) is responsible for this task and offers information and support to researchers.