Have you ever heard of clinical trials? You may not be sufficiently informed. We hear more often about organ donation than about clinical trials, which are also very important. Let’s see what it’s all about!
What is a clinical trial or study?
A clinical trial is a research study (sometimes called a clinical study or protocol) to which people give their informed consent to participate. These are studies that have been carefully designed to try to find better ways to prevent, diagnose or treat diseases or disorders, or to better understand certain diseases, disorders or processes.
One of the most common types of clinical trials is the clinical trial. In clinical trials, researchers work with volunteers to find out how a substance or action affects a person. These substances or actions are also known as interventions and can be drugs, treatments or procedures, medical devices or lifestyle changes (behaviors) such as changes in diet or level of physical activity.
Clinical trials are often designed to see if the intervention helps prevent, detect or improve a disease or disorder. They can compare experimental interventions with existing products or processes. They may also compare experimental interventions with a product or process that looks the same as the intervention being studied, but has no known effect, such as a pill without medication (called a placebo). Clinical trials can also compare two or more existing approaches to determine which is safer or more effective.
You are probably wondering how to find a research center or be selected for a clinical study? For more details, we invite you to turn to BIOTRIAL (biotrial-community-volunteers), a research center that has been carrying out clinical studies in Rennes for more than 30 years.
Do you have to be sick to participate in a clinical trial?
Clinical trials recruit volunteers who share certain characteristics, depending on the objective of the trial. The study protocol indicates who can participate in the study and explains the characteristics that the volunteers must have. These characteristics are known as inclusion criteria (sometimes referred to as eligibility criteria) and may include age, gender, general health, and other risk factors. Many studies include healthy volunteers (with no known significant health problems) in addition to volunteers with a specific disease or disorder or with risk factors for that disease.
Inclusion criteria are a key part of medical research. They help produce reliable results. After reviewing the results and checking whether the approach they are investigating has proven to be effective, researchers can use this information to see who may benefit from this approach.
For example, a new medicine may not work for people with certain risk factors, or it may work better for men than for women. The inclusion criteria also help to protect study participants, as they help ensure that if a volunteer is likely to be injured by any element of the study, they will not be exposed to that risk.
What is informed consent?
Researchers only study people who volunteer to participate in the study. The person interested in volunteering is informed of the risks and benefits of participating in the study, including details of the study approach and the tests that may be performed.
When a person decides to participate, they sign a consent form. This is called informed consent, and this consent lasts as long as the person is participating in the study. In other words, a volunteer can change their mind and leave the study at any time.