How do you find a suitable clinical trial?

• Ask your cancer specialist – this might be your surgeon, radiation oncologist or medical oncologist. They should know about the clinical trials being run at the place where they work and whether the trial would suit you.
• Australian Cancer Trials website – this is the website you are at now. It has comprehensive information about the clinical trials being conducted in Australia. The clinical trials data on the website comes from two sources:
  • The Australian New Zealand Clinical Trials Registry (ANZCTR), which is where researchers are encouraged to register their trial before conducting research in Australia: http://www.anzctr.org.au/
  • The clinicaltrials.gov registry from the United States: www.clinicaltrials.gov
• Other helpful consumer-friendly clinical trial websites are:
  • The National Cancer Institue website in the United States: www.cancer.gov/clinicaltrials
  • The Cancer Research UK website: www.cancerresearchuk.org/
• The majority of trials being conducted in Australia will be registered with ANZCTR and clinicaltrials.gov
• The World Health Organization keeps a database of all clinical trials being run on their International Clinical Trials Registry Platform (ICTRP). You can search their database for clinical trials. Ultimately all trials will be listed with ICTRP and the website will become a single point of access for all clinical trial registries globally. Some examples of trial registries to be included are listed below:
  • the Chinese Clinical Trial Register (ChiCTR): http://www.chictr.org.cn
  • the Clinical Trials Registry India (CTRI): http://ctri.nic.in/Clinicaltrials/login.php
  • ISRCTN.org: www.isrctn.org
    The ISRCTN (International Standard Randomised Controlled Trial Number) is a simple numeric system for the identification of clinical trials worldwide. Any trial and study design can be registered regardless of country or healthcare area: ISRCTN is open to all, although it does mainly attract European and Canadian clinical trials.
  • the Netherlands National Trial Register (NTR): www.trialregister.nl/trialreg/index.asp
  • the Sri Lanka Clinical Trials Registry (SLCTR): https://slctr.lk/
• Please note that trials registered internationally may not recruit in Australia or you may need to be citizen of that country to be eligible. You may need to consider additional factors such as international travel to take part in some of these trials, though this is not always the case. Check out the details on their websites.
• Information on registry websites may not always be presented in a consumer friendly format.

Who can join?

Each clinical trial plan or protocol clearly states who can and who cannot join the trial. Eligibility depends on the research question that the trial is trying to answer.   

The common criteria that are assessed before entering a trial are:

• Type of cancer – most trials study one type of cancer. Phase 1 trials might look at a number of different cancers.
• Stage and extent of cancer – the stage of a cancer is a way to describe the cancer’s size and activity, if it has spread to lymph nodes and if it has spread to other parts of the body at the time a person has first been diagnosed with cancer. Staging systems can be complicated, so it is easier to think about the cancer’s extent. This can be divided into three main categories:
  • localised (only in the place the cancer started and may involve the local lymph nodes)
  • recurrent (the cancer has come back in the same place)
  • advanced (the cancer has spread to other places in the body, or is too big for an operation). It is more helpful to think about the extent of cancer because it reflects how the cancer is currently affecting the person. You can ask for a copy of your pathology report of a biopsy or excision if you have had surgery – this describes the cancer in detail.
• Age group – trials usually have a lower and upper age limit.
• Other health problems – some drugs may be more likely to cause side effects if a person has a certain health problem. For example, a drug might have side effects on the heart and if you had heart disease you might not be allowed on the study.
• Previous treatment for cancer – doctors need to be sure the results are due to the treatment being studied and not due to earlier treatment.
• Performance status – this is a scale for grading how well you are. Most trials will only recruit participants who are at least up and about more than half the day.
• Other tests – often blood tests and scans are needed to determine if you are eligible for the trial. Some blood tests need to be in a certain range to allow trial entry. Scans might be done to make sure the cancer can be measured and to look for unknown problems.

How do you take part?

If you or your cancer specialist find a suitable trial you want to join, you will be asked to supply details to confirm you are eligible for the trial. As described above, this might involve some extra tests and scans. If it looks like you are eligible for the trial an appointment will be made with your cancer specialist and the research nurse. This is to give you all the information you need about the trial. It is helpful to have a list of questions you want to ask – print off the general list of questions about clinical trial participation ‘Should you consider joining a clinical trial?’ and the specific list of questions about clinical trial participation  ‘Should you consider joining a clinical trial?’ and take these to your appointment. Keeping notes about the answers helps too.

It is helpful to take a relative or friend with you to help you remember what was said. You do not have to make a decision at this meeting. You can have as many meetings as you would like before making your final decision. There should be no cost to you for participation. Contact the trial researchers directly about this. The researchers need to get your written ‘informed consent’ before you enter the trial. 

If your cancer specialist is not able to enrol you in the trial you may want to ask your doctor to refer you to someone who is able to enrol you, or you may want to contact the trial research team directly.

What is ‘informed consent’?

Informed consent is a process where you are given all the information you need about the clinical trial before deciding whether to join. It is very important you understand the benefits and risks of taking part in the trial before agreeing to participate.  The type of information that you can expect to be given is:

• the trial purpose and procedures
• the possible risks and benefits of the trial
• your right to make your own decision about participating and your right to leave the study at any time

The information should be explained to you verbally and also written down in a way that you can understand so your questions can be answered. The written information is on the patient information sheet (similar to a fact sheet). You will receive a copy of this to take home and read. You can discuss this with your family, friends, GP, cancer specialist or nurse. 

After discussing all of these aspects of the trial you will be given a form to sign. The form has written details about the information that was discussed and the privacy of your records. If you agree to take part in the study you sign the consent form in the presence of a witness. Even after you sign the consent form you can still leave the study at any time.

What happens if you agree to enter a trial?

The procedures for a randomised clinical trial will be set out in the trial plan. In general, a computer will assign you a code number, in a process like a lottery, and this number will specify your treatment. The plan will specify your subsequent tests and appointments.

You will be given details of who to contact, including who to contact in an emergency.

What are your rights to join or not to join a clinical trial?

Your cancer specialist will still treat you even if you decide not to join a clinical trial. You can take as much time as you need to decide whether to join a trial. It is better to take the information about the trial home with you and discuss it with your family and friends before deciding. You may also like another appointment with your cancer specialist, or seek a second opinion before making your decision. If you join the trial and later change your mind that is okay. You can withdraw from the trial at any time. You will not be penalised and your cancer specialist will continue to treat you even if you are not on the trial.