Clinical trials

Clinical trials

Clinical trials are a crucial part of the research undertaken at Melanoma Institute Australia. Coordinated from the Poche Centre in Wollstonecraft and conducted at locations throughout our network, these trials are conducted to help us find better ways to prevent, diagnose and treat melanoma, as well as help improve the quality of life of melanoma patients.

Our trials are focused on improving the different treatment options available to patients, including surgery, radiotherapy, chemotherapy, systemic therapy and immunotherapy.

All of the Institute’s clinical trials follow a strict protocol approved by a Human Research Ethics Committee. This committee ensures that the rights, safety and well being of participants are protected throughout the trial.

Why participate in a clinical trial?

You may choose to participate in a clinical trial for many different reasons, including:

  • The trial may play an active role in your care and deliver new benefits.
  • You may be the first to access new treatments.
  • You’ll receive a more focused level of attention and care.
  • You’ll increase your knowledge about melanoma.
  • You’ll be helping others by contributing to medical research.

Of course, there are potential downsides associated with participating in clinical trials.
The experimental treatment may have some side effects, it may take up more of your time than conventional treatments, or the treatment simply may not be effective for you.

It’s important to consider these factors before participating in any clinical trial, and you should have a discussion with your doctor if you have any questions or concerns.

Informed Consent

Participation in a melanoma clinical trial is completely voluntary, plus you can withdraw from the trial at any time without affecting your ongoing care.

Before deciding to participate in a clinical trial, you’ll be given an Information for Patients document, which outlines the aim of the trial, procedures involved, duration, benefits, risks and alternative treatment options. You will also have ample opportunity to discuss the trial with your doctor and trial staff.

If you choose to participate in the trial, you’ll be required to sign a Consent Form. Informed consent is an important and continuing process throughout the duration of the trial, giving you full control over your care and treatment.

Clinical Trial Types and Phases

Clinical Trial Types

The U.S. National Institutes of Health (NIH) classify clinical trials into five types as follows:

  1. Treatment Trials – the most common type of trial involving testing experimental treatments such as new drug combinations or new approaches to surgery or radiotherapy.
  2. Prevention Trials – test new ways to prevent disease and disease recurrence.
  3. Screening Trials – test the most effective way to detect a disease.
  4. Diagnostic Trials – conducted to find better ways to diagnose disease.
  5. Quality of Life Trials (or Supportive Care Trials) – explore ways to improve the comfort and quality of life for people with a disease.

Clinical Trial phases

New treatments must go through three “phases” of trials before they can be considered for use;

  • Phase 1 - Involves only a small number of participants where a range of dosage levels are tested and any side effects analysed.
  • Phase 2 - Involves a larger group of participants where a more detailed evaluation of safety and effectiveness is conducted.
  • Phase 3 - Involves a much larger group of participants where the experimental treatment is formally compared with the current standard treatment by randomly allocating each treatment across the test group.

    Random treatment allocation is necessary in Phase 3 trials to ensure the treatments can be compared without bias. Neither you nor the trial staff can choose which treatment you will receive. If the trial involves a new drug it is possible that you and the trial staff might not be told which treatment group you are in; this is known as blinding and is used to prevent bias. In some trials experimental treatments are compared with a placebo – an inactive pill, liquid or powder that has no treatment value. You will be informed if the trial you are considering is blinded or placebo controlled.

To learn more about clinical trials download a detailed information brochure (PDF).