clinical trials

At Galapagos, we see each clinical trial as a milestone on our journey to bring life-changing treatments to the people who really need them.

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 website has been developed to support patients, caregivers and healthcare professionals, and to 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 clinical trials and make an independent decision on whether a treatment can be approved for use. All Galapagos clinical trials are performed according to government regulations that are in place to help protect the rights of anyone taking part in a clinical trial.

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

Phase 1
Phase 2
Safety and dosing
Phase 3
Safety and efficacy
Phase 4
Post-approval monitoring

Phase 1

Phase 1 clinical trials:

  • Occur in a small number of people (often 20 to 80 people)
  • Focus on ensuring the safety of a treatment
  • Test for side effects. Researchers want to determine how much of the treatment is safe to give, and learn how the body copes with the treatment
  • May take place in healthy volunteers or in patients living with the medical condition that is being studied. Healthy volunteer clinical trials are typically organized in 1 or a few clinical trial sites, whereas clinical trials with patients, for instance oncology trials, can take place in a larger number of clinical trial sites and countries

Phase 2

Phase 2 clinical trials:

  • Are tested in a larger group of people (often 100 to 300 patients)
  • Only include patients who have the condition the treatment is looking to treat
  • Test for results. During these clinical trials, 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

Phase 3

If the results from the Phase 1 and 2 clinical trials are positive (they have passed safety checks and have shown evidence the treatment may work), then Phase 3 clinical trials will take place. Here, the treatment:

  • Is tested in a much larger group of patients (often 1000 to 3000 people)
  • Is compared with an existing treatment (standard of care) or placebo to see how well it works

These are the clinical trials that are typically used to register a treatment with medical authorities who might approve the treatment for use.

Phase 4

Phase 4 clinical trials:

  • Occur after the treatment has been shown to be effective and is available to patients
  • Review the long-term safety of the treatment. How well the treatment continues to work in patients will also be monitored

Clinical trial stories

Each individual’s clinical trial experience is personal to them. Hear what it’s like to take part in a clinical 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.

Thank you to Garry, Lisa, Ron and Maxine for sharing their stories.

The experience of participating in a clinical trial might be different from one person to another.