About clinical trials

Clinical trials are studies that can help in the development of new treatments for medical conditions and therefore support us in improving people’s health. This site has been developed to support patients, caregivers and healthcare professionals, and provide tailored information on the clinical trial process, including what is involved and how to take part.

What are clinical trials?

Clinical trials are medical research studies that help to find out whether a treatment works and is safe for use before it can be distributed to the whole population. Regulatory agencies review the results from these studies and make an independent decision on whether a treatment can be approved for use. All Galapagos clinical studies are performed according to government regulations that are in place to help protect the rights of anyone taking part in a trial.

There are four main phases of clinical studies:

These studies occur in only a small number of people (often 20 to 80) and the main focus is to ensure the safety of a treatment. The researchers will test for side effects, determine how much of the treatment is safe to give, and learn how the body copes with the treatment. Often, these studies will take place in healthy volunteers and in one site in the world. Galapagos Phase 1 clinical trials are therefore not included on this site; however, they are published in government public registries.

Phase 2 studies are tested in a larger group of people (often 100 to 300) and include those who have the disease or condition the treatment is looking to treat. During these studies, it is possible to begin to get an idea as to whether the drug is likely to work, and researchers will look to see what dose may work best.

If the results from the studies in Phase 1 and 2 are positive (they have passed safety checks and have shown evidence the treatment may work), then Phase 3 studies will take place. Here, the treatment is tested in a much larger group of people with the disease or condition (often 1000 to 3000) and the treatment is compared with an existing treatment or placebo to see how well it works. This is the trial that is usually used to register with medical authorities that approve the treatment for use.

Phase 4 studies occur after the treatment has been shown to be effective and is available to patients. During these studies, the long-term safety of the treatment will be reviewed. How well the treatment continues to work in patients will also be monitored. 

Read our glossary to see a definition of other commonly used clinical trial terms 


Clinical trials stories

Each individual’s clinical trials experience is personal to them. Hear what it’s like to take part in a trial from different perspectives, including people’s thoughts and feelings throughout the process, and any advice they have for those considering whether it might be an option for them.