Clinical trials

Clinical trials

A clinical trial is a scientific research study designed to find out how to keep improving treatment. Clinical trials may be used to find out more about well-established types of treatment or they may be used to look at new treatments that have been developed in the laboratory and work out the benefits or drawbacks.

What is a clinical trial?

A clinical trial is a scientific research study designed to find out how to keep improving treatment. Clinical trials may be used to find out more about well-established types of treatment or they may be used to look at new treatments that have been developed in the laboratory and work out the benefits or drawbacks.

Research into new methods of treating cancer is taking place all the time. Researchers may be looking at new medicines, a new combination of medicines or a new surgical procedure and they do this by using a clinical trial. Many hospitals around the world are involved in each clinical trial. This means that researchers can look at results from a large number of patients and get a better idea of the success of the treatment. Clinical trials have played a huge role in the dramatic improvements in childhood cancer cure rates in the last 30 to 40 years.

What are the different types of trials?

There are three phases of a clinical trial:
  • phase I trials study brand new medicines
  • phase II trials study medicines which have graduated from phase I trials and are tested with a greater number of people and sometimes with different doses
  • phase II trials are the ones that most children are enrolled in. They involve comparing what has been used as the 'standard treatment' with a new form of treatment. In this way the trial can be seen as a refinement rather than experimentation

How are phase III trials applied?

In order to make comparisons between treatments, each patient participating in a trial is randomly picked to receive one treatment or the other. This means that one group of children will receive 'treatment A' and another group will receive 'treatment B'. Sometimes there are more than two groups. The selection is made by a computer which has no information about your child, so the decision is called random.

What about the results?

The results of the research and treatment will not be known until all the patients have completed the treatment course. This may take several years. However, records are reviewed regularly during the trial and if important information is discovered each doctor involved will be notified so all the findings are shared.

Does my child have to join a clinical trial?

You do not have to consent to your child participating in a clinical trial and if you do, you can at any time decide to withdraw your child from the trial. If this happens, your child will receive the standard treatment.

How do I make a decision about my child joining a clinical trial?

Your child's doctor will explain everything to you and provide all the information you need to help you to make an informed decision.

As well, an information sheet is provided for each clinical trial. It details the course of treatment (called the protocol), possible side-effects and tests that are required. It will also tell you what information and specimens will be collected and sent to the overseas centre.

Questions to ask your doctor

Here are some of the questions you may wish to ask your doctor. You may also want some of the medical terms explained.
  • What type of trial is this and why is it being done?
  • What exactly will the researchers do during this trial?
  • How long will the trial last?
  • How will it affect us – are there any extra tests or hospital visits?
  • What are the benefits and risks and other available treatments?

What safeguards are in place?

There are safeguards in place to protect patients participating in clinical trials. The three main ones are:

What is informed consent?

Informed consent is a process during which your doctor and other health professionals will share with you and your child all the information and advice that will enable you both to decide whether or not to consent to being part of a clinical trial.

The ethical basis for the principle of informed consent comes from Right 7 of the Code of Health and Disability Services Consumers' Rights. You can ask for a copy of the Code at your hospital.

For more information, see the links to resources at the website of the Health and Disability Commissioner below. 

Who's involved in deciding if a clinical trial is safe?

Most clinical trials for childhood cancer treatment are designed by large paediatric oncology (children's cancer) groups. The groups that the Children's Cancer Services in New Zealand are associated with are:

  • COG (Children's Oncology Group) in the USA
  • CCLG (The Children's Cancer & Leukaemia Group) in the UK (formerly the UKCCSG)
  • ANZCHOG (Australia & New Zealand Children's Haematology & Oncology Group)
  • SIOP (International Society of Paediatric Oncology)

What about NZ specific safeguards?

Every clinical trial requires careful assessment by an ethics committee. It is the responsibility of the committee to ensure that it is ethically acceptable for children to participate in the trial. Even though most clinical trials are developed overseas, a New Zealand ethics committee must review each trial before it is approved in this country.

In New Zealand, clinical trials are also reviewed for cultural acceptance by a Maori consultant or by a Health Research Committee which is Iwi representative.

For more information about this process, see the website of the New Zealand Health and Disability Ethics Committees.

Where to go for information and support

On this website

Childhood cancer: Where to go for more information and support

Acknowledgements

All the fact sheets in the Childhood cancer section of this website have been written by health professionals who work in the field of paediatric oncology. They have been reviewed by the members of the National Child Cancer Network (NZ). Medical information is authorised by the National Child Cancer Network Clinical Leader.

This page last reviewed 01 May 2013.
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