Melanoma research and clinical trials

Author: Vanessa Ngan, Staff Writer; Copy Editor: Clare Morrison; Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, October 2013. About Melanoma is sponsored by the New Zealand Dermatological Society Incorporated.


Introduction

There is much research happening in the area of melanoma. Research and clinical trials increase and improve our understanding of how and why melanoma start, and who is more likely to get melanoma. New information coming to light leads to more effective early diagnosis and treatment.

As a patient with melanoma, particularly melanoma in the late stages, being part of a clinical trial can give you access to the newest treatments or procedures available. Here we answer some common questions or concerns you may have if considering taking part in a clinical trial.

What is a clinical trial?

A clinical trial involves a treatment, which can be a drug, device or procedure, closely tested and monitored in a select group of patients. The product under investigation has not been approved by a country’s governing body (e.g. US FDA and NZ Medsafe), and it is not until it has gone through rigorous clinical research and testing that it may become available to the public.

Why should I take part in a melanoma clinical trial?

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

  • Getting access to the most up-to-date and novel treatments that may be years away from becoming widely available. In New Zealand this could mean getting treatments already recognised as “standard therapy” in other countries, but that are currently not funded and readily available in New Zealand.
  • Being part of the discovery of new treatments that may improve your overall outcome and prolong your life (this is especially true for patients with late-stage melanoma).
  • Free treatment. All costs including close supervision and monitoring by a team of health professionals are covered by the clinical trial.
  • Playing a more active role in your healthcare. Clinical trials allow you to be more closely involved with your treatment plan so you can provide valuable feedback on your experiences.

What are the risks of taking part in a melanoma clinical trial?

It is only normal to be a bit unsure about taking part in a clinical trial. Questions you might be thinking could be, what if it makes me feel worse? Is it dangerous? How much time will it take?

Some of the risks and uncertainties you may have about taking part in a clinical trial could be:

  • Will it make me feel worse? Some experimental treatments may cause unpleasant side effects that may be serious or even life-threatening. What you can be sure of is that at all times you will be closely monitored.
  • 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 as well as the benefits of the trial.
  • Is taking part in a clinical trial too dangerous for me? Your doctor or melanoma treatment team will be able to help you decide whether or not taking part 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) whilst someone else gets the active treatment? Placebos are rarely used nowadays 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 being trialed. The options will be carefully explained to you by your doctor and the research staff.
  • How much time will it take to be part of clinical trial? Depending on the trial, more time and involvement may be required than if on standard treatment. You may need to follow strict dietary and treatment rules, and there may be more hospital or clinic visits and investigations.

At any time throughout a clinical trial you can stop taking part and go back to receiving current standard treatment.

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

Taking part in a clinical trial is voluntary. Before taking part, a doctor or health professional linked to the trial will explain to you every aspect of the trial and what your involvement will mean. You will be given a clinical trial informed consent document that provides a summary of the trial and your rights as a clinical trial participant. By signing this document you are giving your official consent to take part 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 taking part in the trial. You will always have the opportunity to ask questions before, during and after the trial.

Links to further information about melanoma clinical trials

 

 

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