The Sydney Melanoma Unit is one of the the most active surgical research centres in Australasia. A broad range of clinical trials are underway at SMU investigating various aspects of melanoma treatment including surgery, chemotherapy, radiotherapy, genetics and immunotherapy.

What is a clinical trial?

The NSW Cancer Council booklet "Understanding Clinical Trials" provides the following description.

"A clinical trial is a scientific study carried out with people. The purpose of oncology clinical trials is to find better ways of helping people living with cancer by improving treatment methods. This is done clinically, that means, by prescribing a course of treatment for a person such as yourself, and then monitoring and recording your condition.

The research is called a trial because it is uncertain whether a new treatment is better than existing ones. The new treatment may still be experimental. In this case it has been carefully planned and tested in the laboratory yet is still not fully accepted as standard treatment for everyone with this condition.

Clinical trials test new cancer treatments or may compare existing treatments to determine the best way of improving health outcomes. Each study tries to answer scientific questions that will find new and better ways to help people living with cancer. The study compares the results of new treatments with those from the best available treatment methods. Some of the treatments you are receiving may need to be tested by this method, and you may be invited to join in one more clinical trials."

This booklet is available either from the NSW Cancer Council (contact 02 9334 1900) or from the Sydney Cancer Centre (contact 02 9515 7695)

WHAT ARE THE STEPS IN DRUG TESTING?

1. Pre-clinical trials
These are performed in animal models to test toxicity and efficacy of the drug and properties related to its uptake, distribution and metabolism. The outcomes of pre-clinical testing determine whether clinical trials will proceed and also influence the conditions selected for clinical trials.

2. Clinical trials
All clinical trials involve testing on humans whose participation is voluntary. There are three levels:

Phase I – a relatively small number of healthy volunteers are treated to test the safety of a new drug.
Phase II – selected patients showing a number of common features, such as age, sex and severity of the disease participate in trials to establish the effectiveness of the drug.
Phase III – large numbers of patients from the ‘clinical setting’ who are widely representative of the patient population are enrolled in the trial. Patients come from all walks of life, often from a number of participating centres. The aim of Phase III trials is to determine whether a new treatment is any better than the standard treatment in a direct comparison of the two.