Research and clinical trials melanoma

Introduction

There is a lot of research in the area of melanoma. Research and clinical trials increase and improve our understanding of how and why melanoma begins, and who is most likely to have melanoma. New information coming to light leads to more effective early diagnosis and treatment.

As a patient with melanoma, particularly late-stage melanoma, being part of a clinical trial can give you access to the newest treatments or procedures available. Here are some common questions or concerns you might have if you are considering participating in a clinical trial.

What is a clinical trial?

A clinical trial involves a treatment, which can be a medicine, device or procedure, carefully tested and monitored in a select group of patients. The product under investigation has not been approved by a country's governing body (for example, the US FDA and NZ Medsafe), and until it has undergone rigorous clinical research and testing will not be available to the public. .

Why should you participate in a melanoma clinical trial?

Several reasons why you should consider participating in a clinical trial include:

• Gain access to the most up-to-date and innovative treatments that may be years from being widely available. In New Zealand, this could mean obtaining treatments that are already recognized as “standard therapy” in other countries, but are not currently funded and available in New Zealand.
• Be part of discovering new treatments that can improve your overall outcome and prolong your life (this is especially true for patients with late-stage melanoma).
• Free treatment The clinical study covers all costs, including supervision and monitoring by a team of health professionals.
• Play a more active role in your health care. Clinical trials allow you to become more closely involved with your treatment plan so that you can provide valuable feedback on your experiences.

What are the risks of participating in a melanoma clinical trial?

It is normal to be a little unsure about participating in a clinical trial. Questions you might be thinking, what if it makes me feel worse? It is dangerous? How long will that take?

Some of the risks and uncertainties you can have when participating in a clinical trial could be:

• Will it make me feel worse? Some experimental treatments can cause unpleasant side effects that can be serious or even fatal. What you can be sure of is that you will be closely monitored at all times.
• Will the treatment do more harm than good? There is no guarantee that a new and novel treatment will work. This is one of the main purposes of a clinical trial. Ask your doctor to explain the risks and benefits of the test.
• Is participating in a clinical trial too dangerous for me? Your doctor or melanoma treatment team can help you decide whether or not to participate in a clinical trial is right for you. In many cases of late-stage melanoma, clinical trials are often the best treatment option.
• What if I get a placebo (sugar pill) while someone else is receiving active treatment? Placebos they are seldom used today if a standard treatment is available. You can expect to receive the current standard treatment for your melanoma or the new and possibly more effective treatment that is being tested. Your doctor and research staff will carefully explain the options to you.
• How long will it take to be part of a clinical trial? Depending on the trial, more time and participation may be required than with standard treatment. You may need to follow strict diet and treatment rules, and there may be more hospital or clinic visits and investigations.

At any time during a clinical trial, you can stop participating and return to the current standard treatment.

What will I need to do to participate in a melanoma clinical trial?

Participating in a clinical trial is voluntary. Before participating, a trial doctor or healthcare professional will explain each aspect of the trial and what your participation will mean. You will receive an informed consent document from the clinical trial that provides a summary of the trial and your rights as a participant in the clinical trial. By signing this document, you are giving your official consent to participate in the clinical trial.

Throughout the clinical trial, you should receive ongoing explanations and updates to help you make informed decisions about whether to continue participating in the trial. You will always have the opportunity to ask questions before, during and after the trial.

Links to more information on melanoma clinical trials

• Melanoma Research Foundation Clinical Trials Finder - USA

• Melanoma trials in New Zealand - The Melanoma Research Institute of NZ

• Clinical trials.gov: international and trial recruitment in New Zealand