What is a clinical study?
All drugs must be tested in clinical studies (also called clinical trials) before they can be approved and prescribed to patients.
During a clinical study, researchers may want to find out if a study drug:
- Has acceptable side effects
- Works the way it is expected to
- Works less well, the same, or better than other drugs
Phases of clinical studies
There are 4 steps in the clinical research process, called “phases”. Each phase has a different purpose to help researchers answer different questions. Early phase studies may look at whether a study drug is safe or causes side effects. Later phase studies may compare the study drug with other treatments already approved for the same purpose.
We test the study drug in a small group of people, usually healthy volunteers. We are looking at its safety, and how the body handles it. This helps us investigate different doses of the study drug and learn more about what side effects may occur when different doses are given.
We give the study drug to people who have the condition we are trying to treat. We check if it is effective and continue to monitor its safety. This phase helps us understand how well it works and refine the dosage.
We test the study drug in a much larger group of patients. We might compare it with existing treatments. This phase confirms if the study drug is well tolerated and effective. If the study drug successfully finishes Phase 3, it can be submitted to health authorities to get approval for more widespread use.
This happens after the study drug is approved and available to patients. We keep track of its long-term safety and effectiveness in real-world use. We might also study it for new uses or in different patient groups.
The SCALA Study is in Phase 2. It will enroll people who have COPD with chronic bronchitis.
Where do clinical studies take place?
Clinical studies take place in clinics, hospitals, healthcare facilities, or even in your own home. During a clinical study, you will be supported by a dedicated team of researchers, doctors, and nurses, each of whom is committed to your health and well-being.
By joining a clinical study like the SCALA Study, you could possibly help others with COPD in the future.
Interested?
See if you may qualifyUseful links
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