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Clinical trials



What is a clinical trial?

The World Health Organisation defines a clinical trial as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes”. Put simply, a clinical trial is a study that compares responses to different interventions in real settings, to test the effectiveness of medicines or other health measures. Clinical trials are voluntary and are governed by strict rules and ethics.

They are often undertaken in a clinical setting, such as a hospital or outpatient clinic. The participants are usually patients, but they may include former patients and people who are well. 

Clinical trials are an important way to improve treatment for people with cancer – and the only way to thoroughly evaluate the effects of a clinical intervention. If a clinical trial proves that a test or treatment is more effective than existing options, it may become the new standard of care for patients in the future. A trial can also identify potential risks and side effects.  


Who can participate in a clinical trial?

Clinical trials are open to adults and children, however children under 18 need their parents’ or guardians’ permission to be involved.

There are guidelines for each clinical trial about who can join, called eligibility criteria. The inclusion criteria outline characteristics that ensure people taking part share certain commonalities, such as gender, age or diagnosis. The exclusion criteria consider factors that could make participation risky for an individual.

Trials can be conducted over a number of years, and it can take some time for the results to be published in medical journals and other science literature.

Participation is voluntary, and you can withdraw from a study at any time. If you pull out, you will still be able to receive the type of treatment that is currently the best option for you. 


What do I need to know before beginning a clinical trial?

Researchers must provide written information about the clinical trial to anyone who is thinking about participating, including:

  • the purpose and phase of the trial
  • who is running the study
  • who has approved the research
  • who is funding the study
  • how the study will be run
  • what will be required of a participant (including length of involvement and potential side effects or other risks)
  • information about your rights, such as confirming that medical records are private and confidential
  • contact details for the person who will be able to explain who may have access to your information and for what purpose.

It is a legal requirement that all personal information collected as part of a clinical trial is stored securely for at least 15 years before it can be destroyed. 

If you decide to participate, you will first have to give your informed consent by signing a form, confirming that you have read and understood the purpose, risk and possible outcomes of the trial.


Are clinical trials safe?

All clinical trials in Australia are regulated by an international standard of practice, called Good Clinical Practice. These standards ensure trials are conducted to a high scientific standard and that they are safe for people taking part.

Several committees examine and approve a clinical trial before it commences, and confirm that the study is considered to be of scientific merit and fair (ethical).

Researchers must follow strict guidelines to make sure studies are as safe as possible for everyone involved – this is called their duty of care.


What is a randomised controlled trial?

Randomised controlled trials are considered the best way to test if a new treatment is effective. This is because they “control” for biases, which can occur when the results of a trial are influenced by factors not related to the treatment being tested. Randomised controlled trials are designed to eliminate biases by “randomly” selecting participants and “controlling” for other factors.

Typically, participants in a clinical trial will be put in one of two groups:

  • test or experimental group – are given the new treatment being assessed;
  • control group (or arm) – are given an established treatment that is already in use, other standard care or a placebo. 

Will I be given a placebo?

Placebos (inactive or fake treatment) are not often used in cancer treatment trials. Only trials that use a placebo together with the best standard therapy are approved. Placebos are not used if a participant would be put at risk by not being given an effective treatment. Potential participants are told if placebos will be used in the trial before they agree to participate.

What is a blind study?

When participants don’t know which study group they are in, this is called a blind study. Some randomised controlled trials are called double-blind studies – this is when both the trial team and participant don’t know which group the participant is in.

If your doctor needs to find out what treatment you’re having for safety reasons they are able to find out by contacting the trial organisers.


What does it cost to participate?

Participation in a clinical trial is free for Australian residents and citizens. There may be out-of-pocket expenses, such as travel, which may also be reimbursed to you. Unfortunately, Australia’s vast distances can make it difficult for people in remote areas to participate in clinical trials.

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What do the different clinical trial ‘phases’ mean?

Researchers may spend years developing new treatments and medicines before involving people. Clinical trials are then developed to progress in a series of steps called ‘phases’. There are generally four phases and the information gathered in each determines if the study can move on to the next phase. See the illustration below for more information on what happens during a clinical trial. 

Clinical Trials and Research Phases© Cancer Council NSW. Reproduced with permission from Understanding Clinical Trials and Research publication.


Clinical trials team

If you join a study, you may have contact with some of the following professionals:

  • medical specialists such as oncologists, surgeons and haematologists
  • clinical trials nurse or research nurse
  • clinical trials or study coordinator
  • allied health practitioners
  • contact person for you during the trial
  • researcher or investigator
  • principal investigator
  • pharmacist.

You should also be given details of the approving Ethics Committee and trial secretariat. 


Support during and after the trial

All studies include a contact person, who is often the clinical trials nurse or study coordinator. However, you will also be given access to a person independent of the research team, in case you have a complaint about the study. This is one of the participant’s rights of joining a study.

After the trial is finished, researchers may stay in contact with you for some time so they can collect long-term information on your health.


Finding a study

There are many ways to find out about a clinical trial. A good starting place is the Australian New Zealand Clinical Trials Registry (ANZCTR), an online register of clinical trials being undertaken in Australia, New Zealand and elsewhere. It includes trials from the full spectrum of therapeutic areas of pharmaceuticals, surgical procedures, preventive measures, lifestyle, devices, treatment and rehabilitation strategies, and complementary therapies.

This registry has been established at the National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, with funding from the NHMRC and New Zealand Health Research Council.

The government cancer agency, Cancer Australia, also has online information about current cancer clinical trials, in partnership with the Australian New Zealand Clinical Trials Registry, the University of Sydney and consumer group Cancer Voices.   

You can also ask your treatment team or GP if they are aware of any trials that could be available and appropriate to you. If not, they should be able to put you in touch with the local clinical trials or research nurse to find out if there are any suitable studies for you to consider.


Questions to ask

Even though it is mandatory for a clinical trial to supply patient information about the trial, it is important that you ask any questions you may have before joining a study. Examples of questions include:

  • What is being tested in the trial and why?
  • What are the contact details of the Ethics Committee that has approved the study?
  • Who will oversee my cancer care while I am participating?
  • Where will I receive treatment and for how long?
  • Who do I contact if there is a problem?
  • What are my chances of benefitting from this research?
  • What are the risks to me?
  • Will I experience any side effects? How will they be treated?
  • What type of tests are involved?
  • How long does the study go for?
  • Can I receive reimbursement for out-of-pocket expenses?
  • If I join this study, will I miss out on other treatment opportunities later?
  • Can I still take other medication or complementary therapies while I am involved in the trial?
  • Who will have access to my personal information as part of the trial?
  • How much time do I have to decide if I want to participate? 

Source

Understanding Clinical Trials and Research, Cancer Council Australia © 2015. Last medical review of this booklet: May 2015.

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For more information

For support and information on cancer and cancer-related issues, call Cancer Council 13 11 20. This is a confidential service.

Booklets 

ncludes additional information on clinical trials in Australia as well as other types of research, making decisions around participating in research, and contact details for professional bodies involved in clinical trials. 

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This page was last updated on: Tuesday, October 31, 2017

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