A clinical study is a research study conducted with human volunteers to answer specific health questions. Clinical studies are carefully conducted and monitored to find better ways to prevent, diagnose or treat medical conditions.
Millions of people participate in clinical studies every year. By choosing to participate in a clinical study, you can make a difference to your life and the lives of others.
Who can participate?
Some studies involve people with a particular medical condition, others involve healthy volunteers. Each study has a set of rules about who can participate, based on things like current medical conditions, current treatment or age.
What is an informed consent form?
If you decide to take part in a clinical study, you will be given a document called an informed consent form which explains the study to you. Your study doctor or study staff will go through this document with you and answer any questions you may have. You must sign the informed consent form to confirm that you have decided to take part in the study.
The informed consent form is not a contract, and you may withdraw from the study at any time.
How is my safety protected?
The health and safety of all participants is the highest priority in a clinical study. Research teams follow strict ethical and scientific rules, all of which must be approved by your country’s authorities and an independent ethics committee. You should contact the study staff immediately if you have any safety concerns.
What happens during a clinical study?
The clinical study process depends on the type of study being conducted. The doctor or study staff will explain the process to you fully before you start.
Participation in a clinical study often means more clinical visits or medical tests than you would normally have. The study staff may also call you between visits.
What is a placebo or ‘dummy drug’?
A placebo looks the same and is given the same way as the active treatment, but does not have any effect on the body. In clinical studies, treatments are often compared with placebos to understand the benefit of the new medicine compared with no medicine. Placebos are not harmful in any way.