About clinical research

What are clinical studies?

The aim of clinical research is to identify the most effective and safe drugs that enable people to live healthy lives. Drugs must be tested in clinical research studies before they can be approved and prescribed or used by the general public.

During a clinical study, researchers may find out various things about an investigational drug, including whether it:

• Is safe to take
• Has any side effects
• Works better than other drugs
• Can make you feel better

Types of clinical studies

There are 4 types of clinical studies, called ‘phases’. Each phase has a different purpose to help researchers answer different questions. Early phase studies may look at whether an investigational drug is safe or causes side effects. Later phase studies may compare the investigational drug with other treatments already approved for the same purpose.

Phase 1 – The investigational drug is given to a small group of healthy volunteers or people with the target condition. Researchers look to see how much drug is safe to take and how the human body responds when receiving the drug.

Phase 2 – The investigational drug is given to a small group of people with the target condition, or condition it is intended to treat. In this phase, researchers are evaluating what dose is appropriate and begin to test the safety and effectiveness of the investigational drug.

Phase 3 – Researchers test the safety and effectiveness of the investigational drug (at a dose determined in Phase 2) in a larger group of participants over a longer period of time. Sometimes comparisons are made between the investigational drug and other medications that are already approved for the same purpose.

When the investigational drug has passed these 3 phases, it is ready to be launched. Even if the drug is approved for use, it still needs to be monitored. During the final fourth phase (Phase 4), researchers test how well the drug works over a longer period.

The FLASH Study is in Phase 2.

Who is involved in clinical studies?

Clinical studies often take place in study centres, which may be health clinics, hospitals or surgeries. During a clinical study, you will be supported by a dedicated study team, each member of which is committed to your health and well-being. This team typically consists of nurses and doctors, but may also include study coordinators and other healthcare staff.