About clinical research

What is clinical research?

Clinical research studies (also called clinical trials) are critical for advancing the treatment of medical conditions and diseases. All drugs must be tested in clinical research studies before they can be approved and prescribed to patients.

During a clinical study, researchers may want to find out the following about an investigational drug:

• If it has manageable side effects
• If it works the way it is expected to
• If it works less well, the same or better than other drugs
• How it behaves in the human body (e.g. where is it transported, how quickly it leaves the body, etc.)

Types 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 (1 to 2) may look at the safety of an investigational drug or find out what dose is appropriate. Later phase studies (3) may compare the investigational drug with treatments already approved for the same purpose. At each phase of development, government agencies check the results to see whether the investigational drug being tested can continue to the next phase.

When the investigational drug has passed 3 phases, it may be ready to be submitted for approval. Even if a drug is approved for use, it still needs to be monitored. During this final 4th phase, researchers test how well the drug works over a longer period when it is used outside of a clinical research setting.

The UP0110 Study is in Phase 1/2.

Who else is involved in clinical research studies?

Clinical research studies take place in private practices, clinics, hospitals or surgeries, which are called study centers. During a clinical study, you will be supported by a dedicated study team that typically consists of nurses and doctors, and can also include study coordinators or other staff involved in the study who will closely monitor your health and well-being.

Is participation in a clinical study 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 UP0110 Study will not affect your current or future relationships with your doctor(s) nor any health benefits to which you are entitled.