What is a clinical trial?

Clinical trials form the link between discoveries made in the cancer research laboratory and making new treatments available for people diagnosed with cancer. It is extremely important that all new therapies and procedures associated with any cancer care be accurately proven and long-term safety determined before they can be recommended for general or standard use.

What types of clinical trials are there for breast cancer?

Detection or screening trials evaluate the best approach to find a cancer in its early stages; for example mammograms (breast x-rays).

Prevention trials test new approaches; e.g. use of medicines or healthy lifestyle changes that may lower the risk of getting certain cancers.

Treatment trials test new treatment; e.g. drugs such as chemotherapy or hormonal treatments. New radiotherapy or surgical techniques are also tested. Counselling and psychological support or ways of providing better communication are also part of treatment trials.

Quality of life studies pay special attention to a breast cancer patient’s feeling’s about the impact and side effects of treatments. These studies look for ways to improve the overall experience for patients who receive these treatments in the future.

What are the different phases of clinical trials

Clinical trials are generally conducted in four phases. Each phase is designed to answer certain scientific questions.

Phase 1 Trial

Phase 1 clinical trials are conducted to test a new biomedical intervention for the first time in a small group of people (around 20-50 people) to evaluate the safety and side effects of the new treatment or intervention. Phase 1 trials are not randomised.

Phase 2 Trial

If the treatment or intervention is proven successful in phase one, it is moved to a phase 2 study and tested in a larger group of people (several hundred) to determine how effective it is and to further evaluate its safety.

Phase 3 Trial

Phase 3 clinical trials compare new treatments with the best currently available treatment (standard treatment). Phase 3 clinical trials study the effectiveness of a treatment or intervention in large groups of people (several hundred to several thousand). It looks at which treatments work best for the disease, how the treatment affects quality of life and learns more about side effects. A phase 3 clinical trial could compare the standard treatment with a new treatment, a different dose of the same treatment or a different way of giving the same treatment.

Phase 4 Trial

A phase 4 clinical trial is conducted after the new treatment or intervention has been marketed and approved. A phase 4 clinical trial aims to learn more about the side effects and safety of the new treatment, 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.