About clinical research

What is clinical research?

Clinical research takes place in clinical studies (also called clinical trials). It is essential for advancing the management or treatment of medical conditions and diseases. All potential medications must be examined in clinical studies before they can be approved and prescribed for people to use. While these medications are still being examined, they are known as “investigational”.

During a clinical study, researchers may want to find out various things about an investigational drug, such as:

Its safety, as determined by how a participant reacts to and tolerates the investigational drug
What side effects are reported

If it can make people feel better or improve their condition
What dose might be most suitable

Phases of clinical research

There are 4 stages in the clinical research process, called “phases”. Each phase has a specific purpose to help researchers answer different questions.

At each phase of development, health authorities check the results to see whether the investigational drug being tested can continue to the next phase.

Phase 1

The investigational drug is tested in a small group of healthy people. The study looks at the tolerability of the investigational drug and how the body handles it. Tolerability means how bearable any side effects are. This phase of research helps with finding the right dose and spotting any side effects.

Phase 2

The investigational drug is given to people who have the condition it is aiming to treat. The study checks if the investigational drug is effective and continues to monitor its tolerability. This phase helps researchers understand whether it works, to refine the dosage and spot any additional side effects.

Phase 3

The investigational drug is tested in a larger group of patients. It may be compared to existing treatments or a placebo (inactive treatment). This phase confirms the investigational drug’s tolerability and if it is effective for widespread use. Once Phase 3 has been successfully completed, the investigational drug may be ready to submit for marketing approval.

Phase 4

This happens after the investigational drug is approved and available to patients. The approved drug’s long-term tolerability and efficacy is tracked during real-world use. Researchers might also study it for new uses or in different patient groups.

Each phase builds on the knowledge from the previous one, helping to ensure the tolerability and efficacy of new drugs and medicines before they become widely available.

The PHOENYCS FLY Study is in Phase 3.

Who else is involved in clinical studies?

Clinical studies take place in clinics, hospitals, private practices, or surgeries. These are all called study centers (or study sites). During a clinical study, you will be supported by a dedicated study team. This team typically consists of doctors, nurses, and other healthcare professionals. It may also include study coordinators and other staff. The study team is committed to closely monitoring your health and well-being.

Is taking part in clinical research voluntary?

It is completely up to you to choose if you want to take part in a clinical study. Whether or not you decide to participate in the PHOENYCS FLY Study, this will not affect your current or future relationship with your doctor(s) nor any health benefits to which you are entitled.

Suggestions

About clinical research

What is clinical research?

Phases of clinical research

Phase 1

Phase 2

Phase 3

Phase 4

The PHOENYCS FLY Study is in Phase 3.

Who else is involved in clinical studies?

Is taking part in clinical research voluntary?

Clinical studies at UCB

By joining a clinical study, you might have the opportunity to learn more about your condition and help others living with SLE in the future.

Suggestions

About clinical research

What is clinical research?

Phases of clinical research

Phase 1

Phase 2

Phase 3

Phase 4

The PHOENYCS FLY Study is in Phase 3.

Who else is involved in clinical studies?

Is taking part in clinical research voluntary?

Clinical studies at UCB

By joining a clinical study, you might have the opportunity to learn more about your condition and help others living with SLE in the future.

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