What is a clinical trial?

Clinical trials are very important as they help develop a greater understanding of melanoma to improve the ways we can prevent, screen, diagnose or treat it, and ultimately improve the quality of life of those who have the disease.

Clinical trials take place all over the world and vary considerably in size and scope. They are conducted by doctors, nurses, scientists, research assistants, data managers, pharmacists and other health professions; teams who work together to look after patients during the course of the trial.

To ensure that the rights, safety and well-being of participants involved in trials are protected, each trial follows a Human Research Ethics Committee-approved, carefully controlled protocol. The protocol is also a detailed plan for the aims of the research.

Trials are strictly voluntary and you have the option of withdrawing at any time.

There are a number of reasons why participants tell researchers that they like being involved in clinical trials. These include:

• An empowering feeling of being involved in your healthcare,
• potential health benefits,
• being a part of something that an change the lives of others for the better,
• experiencing a feeling of more care and attention, and
• learning about melanoma.

There may also be risks or downsides involved in participating in an experimental treatment, such as:

• Receiving no positive effect,
• experiencing potentially negative side effects,
• risk of randomisation to placebo (non-active)/observation group and
• devoting your personal time to the research and study visits.

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Clinical trial types and phases

Trials:

• Treatment trials: tests experimental treatments, new drug combinations or new approaches to surgery or radiotherapy.
• Prevention trials: tests new ways to prevent disease in people who have never had the disease or to prevent the disease from returning in those previously treated.
• Screening trials: tests the best way to detect a disease.
• Diagnostic trials: conducted to find better tests or procedures for diagnosing a disease.
• Quality of Life trials (or Supportive Care trials): explores ways to improve the comfort and quality of life for people with a disease.

Phases:

1. Phase I - The first study of the experimental treatment that involves humans. Safety and dosage range are tested and side effects identified. Only a small number of people are involved. In clinical trials for cancer treatments only those with the diseae are used however when testing non-cancer drugs usually only healthy volunteers are invited to participate.
2. Phase II - A more detailed evaluation of effectiveness and safety. A larger number of people are required for a Phase II trial.
3. Phase III - A formal comparison of the experimental treatment with the current standard treatment to work out which is best. A large number of people are involved across many different locations often in many different countries.
4. Phase IV - The use of an already used medication or treatment in a new and similar disease or the monitoring of newly approved medications that have successfully passed through the previous 3 phases and recently been registered.

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