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    Clinical trials

    Contents

    This information explains what clinical trials are, why they are necessary and how they are done. There are many different types of studies and trials that people may be invited to take part in. This information is mainly about clinical trials for new drug treatments as these are the most common type of trials.

    Clinical trials test promising new treatments on people to see if they are better than existing standard treatments. They help to find better treatments for cancer. The trial process of developing new treatments is a long process, starting many years before an actual treatment is able to be used.

    By joining a clinical trial cancer patients can help cancer research. Hundreds of thousands of people all over the world have taken part in clinical trials. These trials have found safer and more effective treatments for many cancers.

    It is important to note that not all cancer patients are eligible to take part in clinical trials and there are not clinical trials for all types of cancer.

    You should not participate in a cancer clinical trial unless it has approval from an Australian Human Research Ethics Committee. All Australian cancer clinical trials are required to be registered with the Australian and New Zealand Clinical Trials Registry (www.anzctr.org.au).

    You can check the credibility of trials at government websites such as
    www.australiancancertrials.gov.au and clinicaltrials.gov from the USA.

    Please click here for a list of current clinical trials.

    Why you might consider joining a clinical trial

    You may decide to join a clinical trial because:

    • The treatment you receive will be at least the best available for your illness.
    • Your health may improve because of the treatment you receive.
    • You may receive a treatment you would not otherwise be able to access.
    • Your health will be carefully checked by the treatment team running the trial.
    • You will be a part of the worldwide effort to improve cancer treatment.

    Cancer Council SA supports clinical trials of promising new cancer treatments. This is because patients who are treated in clinical trials usually fare better than patients who do not join a clinical trial because of the frequent monitoring throughout their treatment. Cancer treatments are improving because of the results of clinical trials of new treatments.

    Some improvements achieved through clinical trials are:

    • That breast conserving surgery is as good as total mastectomy (dependent on individual circumstances/pathology), provided radiotherapy is also given after the surgery.
    • That hormones or chemotherapy after breast cancer surgery improve the chance of cure.
    • Better, more effective treatment for childhood leukaemia.
    • That bone marrow transplants can be helpful in treating adults with leukaemia.

    With the assistance of clinical trials the overall survival rate for children with cancer has increased from less than 15% to more than 80% in the past 20 years.

    A word of caution. There is a lot of cancer information on the internet.
    Cancer Council 13 11 20 Information and Support has a brochure listing reliable websites as a guide on how to use the internet wisely.
     

    Clinical trials explained

    There are different types of trials:

    • The treatment tested may be new—a drug, radiotherapy, surgery or other procedure not yet in general use.
    • A known treatment may be tested in a new combination with another known treatment.
    • Approved drugs are tested for a different type of cancer, different follow-up or cancer investigations.
    • The trial may test supportive care programs such as cancer support groups or relaxation therapy, to help with the emotional effects of cancer.
    • A drug may be tested in people at high risk of cancer to see if it prevents the disease developing.
    • Testing for strategies to reduce the side effects of treatment or to improve quality of life of patients.

    The three phases of clinical trials

    Phase 1

    These trials are the first step in testing a new treatment in people. They find out the safety of the proposed treatment.

    •  Looks at how a new treatment should be given, how often and if it involves medication, what dose is safe. In drug trials the best dose of the drug is determined by examining the side effect rate and severity of side effects.
    • Because less is known about the possible risks and benefits in Phase 1 trials only a limited number, usually about 20, patients are able to participate. These patients can be enrolled in the trial because no standard treatment is available and they are reasonably fit.

    Phase 2

    • Continues to test the safety of the treatment.
    • Assesses how well the new treatment seems to work.
    • Usually involves about 30 to 300 people.
    • Information gathered in these trials will determine whether the treatment proceeds to Phase 3.

    Phase 3

    • Compares a new treatment to the best standard treatment, to work out which is best.
    • Assigns people at random to receive the new treatment or the best standard treatment.
    • Involves hundreds or thousands of patients to be recruited in order to measure any differences between the tested treatments.

    Randomised controlled trials

    There are different ways to conduct trials. Randomised controlled trials are thought to be the best way to test new treatments. A ‘controlled’ trial compares a group which receives a promising new treatment with a group which receives the best standard treatment (this is known as the control group).

    In a randomised controlled trial none of the people either participating in or running the trial can choose which treatment each person will be given because the treatments are assigned by chance. In a ‘double blind’ trial or study neither the study participants nor the treatment team know which patients receive which treatment. This helps avoid bias. Without this blinding patients or treating staff who know which treatment they are taking might expect it to work better or worse. If patients expect it to work well they might report hopeful signs and not report bad signs. This would bias the trial by making the results look better than they really are.

    Issues to consider

    If you join a clinical trial your treatment will be either the best standard treatment for your illness, a new treatment that may be better or a new treatment that could be worse than the standard treatment. The purpose of the trial is to find the best option.
    In a clinical trial you will receive high quality medical care from the treatment team, during and after your treatment. Depending on the trial this may be for days or weeks or for months or years.

    Some other points to consider

    • If the treatment you are given does not act on your cancer, it will be stopped. Your doctor will then discuss other ways to treat your cancer.
    • Being in a clinical trial may involve some risks, side effects and some extra time for hospital visits for further tests. These will be explained to you before you consent to join the trial.
    • The trial treatment may or may not work for patients enrolled in the trial. However treatment may or may not work in patients who do not participate in clinical trials.

    Ethical issues and patients’ rights

    In Australia clinical trials have to be approved by a Human Research Ethics Committee before they can begin. These committees are independent and include scientists, doctors, lawyers, ministers of religion and people from the general community. They make sure trials are run only if they are needed and are run in an ethical and scientific way. Human Research Ethics Committees are regulated by the National Health and Medical Research Council, a federal government body www.nhmrc.gov.au

    How you join a clinical trial

    Your doctor may suggest you join a trial if a suitable new treatment is being tested at the time you and your doctor are deciding on your treatment. Or you may like to ask your doctor about clinical trials for your illness.

    These websites may provide further information:

    www.australiancancertrials.gov.au
    www.clinicaltrials.gov
     

    Making an informed decision

    After talking to your doctor and clinical trial coordinator about the clinical trial you may find it helpful to discuss it with your family and friends. It is important for you to take your time to make the right decision. You might even decide to seek a second opinion.

    If you decide to take part in a clinical trial you will be given written information about the trial and asked to sign an informed consent form. This tells you about treatments that you may receive, possible benefits, possible risks and side effects and responsibilities as a trial participant.

    Remember you have the right to withdraw from a clinical trial at any time.

    Doing so will not affect your relationship with your doctor or the continued treatment of your cancer.

    If you decide not to join

    As part of your decision your doctor will discuss the best standard treatments available to you. If you decide not to participate you will be offered the best standard treatment available.

    Where are clinical trials conducted?

    South Australia’s cancer specialists have a very good record in contributing to state-based, national and international clinical trials. Many of the main hospitals/treatment centres are involved in clinical trials. Many specialists in private practice are also involved in national and international clinical trials. In South Australia there are cancer clinical trials performed at Royal Adelaide Hospital, The Queen Elizabeth Hospital, Flinders Medical Centre, Lyell McEwin Hospital and Adelaide Cancer Centre at the Tennyson Centre.

    How trials change cancer treatment?

    It normally takes several years before the results of a trial are known. Researchers follow up what happens to patients, calculate and interpret results and prepare reports. The results are usually first presented at a meeting of the researchers involved in the trial. The next step is to present the results to cancer researchers not involved in the trial. There is usually extensive questioning and debate.

    A report is then prepared and submitted to a medical journal. The report is peer reviewed—this means that independent experts in the field provide criticisms, questions and suggestions. If the researchers are able to answer these satisfactorily, the medical journal will accept the report and it is published.

    When a study is published in a medical journal it allows many doctors to consider the study, to debate the issues and consider whether they should change the way they treat cancer.

    If the new treatment is proven to be better, based on the available medical evidence, clear recommendations can be made about the treatment, such as who should have it, in what dose and for how long.

    Questions to ask your doctor

    To help you make an informed decision about joining the clinical trial, your doctor will discuss the trial and how it may affect you. You may like to ask some of the following questions.

    • Which treatment/s are being tested and why?
    • Will I benefit from taking part in the trial?
    • What are the risks to me?
    • What side effects might I get?
    • Which tests are involved?
    • What is likely to happen to my condition with or without this treatment?
    • How long will the trial last?
    • Do I need to go into hospital for the treatment?
    • How will the treatment affect my daily life?
    • Who can I contact if any problems arise?
    • What treatment costs are involved?
    • Will there be compensation (for fuel/parking) if extra visits are needed as part of the clinical trial?
    • How will my privacy be protected while I am in the trial?
    • If I say no will my regular treatment be affected?
    • Which treatment will I receive if I do not take part in the trial?
    • What happens if I change my mind?
    • Will I be told about the results of the trial?

    Useful websites

    Disclaimer: The opinions and recommendations contained in these websites are not necessarily those of, or endorsed by Cancer Council SA. This list is not exclusive. There may many other reputable sites that have not been included.

    Australian New Zealand Clinical Trials Registry
    www.anzctr.org.au

    Ludwig Institute for Cancer Research, Melbourne
    www.ludwig.edu.au

    National Health & Medical Research Council, Clinical Trials Centre
    www.ctc.usyd.edu.au

    Flinders Cancer Clinic, Flinders Medical Centre
    www.flinders.sa.gov.au

    Cancer Council Australia
    www.cancer.org.au

    Cancer Clinical Trials NSW—information about clinical trials and details of funded trials
    www.cancercouncil.com.au/research

    Cancer Council Victoria—details of clinical trials funded
    www.cancervic.org.au/trials

    Cancer Trials Australia
    www.cancertrialsaustralia.com

    International

    US Institutes of Health
    www.clinicaltrials.gov
     

    Want to know where this information comes from? Click here.

     


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