What is a Clinical Trial?

Breast cancer clinical trials are a vital part of our health system. They offer the opportunity to test whether new treatments are more effective than those currently accepted as the best available standard of care.

Clinical trials can also compare new treatments and test new ways to use or combine existing treatments, to ensure that all patients are receiving the best standard of care available. The trials conducted by Breast Cancer Trials are widely recognised for their high-quality patient care and practice-changing results.

All new treatments or preventions strategies must be rigorously tested in clinical trials before they are made widely available in the community, with patient safety remaining the highest priority to our researchers.

What are the Phases of a Clinical Trial?

Clinical trials are generally conducted in four phases, with each phase being designed to answer particular scientific questions.

Phase One

Phase one clinical trials are conducted to test a new treatment for the first time in a small group of people, usually around 20 to 50 people. A phase one trial evaluates the safety and side effects of the new treatment or intervention.

Phase Two

If the treatment or intervention is proven successful in phase one, it is then moved to a phase two clinical trial and tested in a larger group of people. A phase two clinical trial aims to see how well the new treatment or intervention works against cancer and to monitor for side effects.

Phase Three

Phase three clinical trials compare new treatments with the best currently available treatment, also known as standard treatment. These clinical trials can also test standard treatment with a different dose of the same treatment or a different way of giving the same treatment. Phase three clinical trials study the efficiency of a treatment or intervention in large groups of people, from several hundred to several thousand. It looks at which treatments work best for the disease, how the treatment affects quality of life and helps researchers learn more about the treatment or interventions side effects.

Phase Four

A phase four clinical trial is conducted after the new treatment or intervention has been marketed and approved. A phase four clinical trial aims to learn more about the side effects and safety of a new treatment or intervention, the long-term risks and benefits of the new treatment, and how effective the treatment is when used in the general population over a longer period of time.

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