What are clinical studies and why are they important?
Researchers and doctors are always looking for better ways to treat health conditions. Clinical studies test if a new treatment is safe, and how well it works.
Before health authorities can approve a new treatment, they need to know how well it will work, and if it is safe, based on the results from clinical studies.
Clinical studies are an important step in finding new and better treatments for people around the world!
All clinical studies need to pass three clinical study phases before they can be approved: Phase 1, Phase 2 and Phase 3.
Phase 1 studies are usually the first time a potential treatment is studied in people. These studies often include a small number of participants and are mainly designed to learn more about safety, how the treatment moves through the body, and what dose may be appropriate for future research.
Phase 2 studies include more participants than Phase 1 studies. These studies help researchers learn more about the treatment’s safety and begin to understand whether it may work for people with a specific disease or condition.
Phase 3 studies usually include the largest number of participants, often hundreds or thousands of people with a specific disease or condition. These studies collect more information about how well the treatment works and its safety in a larger group of people.
Clinical studies are carefully designed and follow a detailed study plan. Some studies are randomized, which means participants are assigned to a treatment group by chance, similar to flipping a coin.
Some participants may receive a placebo. A placebo looks like the study treatment but does not contain any active medicine.
Many studies are also blinded. This means that you and your study doctor may not know which treatment group you have been assigned to during the study. Blinding helps researchers compare results as fairly as possible.
If you decide to join a clinical study, you may be asked to:
- Take or receive the treatment assigned to you
- Attend regular study visits
- Have medical tests and assessments to monitor your health
- Answer questions about your symptoms, daily life, or how you are feeling
- Tell the study team about any changes in your health or medications
The study team will explain what is involved before you decide whether to take part.
If you are interested in joining a clinical study, the study doctor or study team will talk you through the details. They will explain what the study is testing, how long it may last, what visits and assessments may be required, and the possible risks and benefits of taking part.
You will have time to ask questions and decide whether participation feels right for you.
Before joining, you will be asked to read and sign an Informed Consent Form (ICF). This form explains important information about the study, including:
- What participation involves
- The possible risks and benefits
- Your rights as a study participant
- How your information will be used and protected
- Who to contact if you have questions
Signing the Informed Consent Form means you agree to take part. However, participation is always voluntary, and you can choose to leave the study at any time.
Possible benefits
- Regular health check-ups and close medical monitoring
- Study treatments and related tests at no cost
- Possible improvements in your health or condition
- You will be helping in the search for new and better treatments for your condition
Possible risks
- You may not receive the new treatment and could be given a placebo (for part or all of the study)
- You may have side effects from study treatment
- You need to make time for health check-ups and study assessments
- Your health may not improve or could even get worse while you are in the study