Before a trial begins, researchers develop the protocol. This detailed plan describes the study’s design, reasons for the study and who can participate (the eligibility criteria).
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All clinical trials have guidelines for who can join, called the eligibility criteria. This outlines the characteristics that must be shared by all participants to ensure that people taking part are as similar as possible.
The inclusion criteria describes the required characteristics for enrolling in a study. The exclusion criteria outlines the factors that disqualify someone from participating.
Depending on the research, eligibility criteria may include:
- age or sex
- cancer type
- stage of the cancer
- symptoms or side effects experienced
- length of time since diagnosis or treatment
- previous medical history
- previous medical treatments.
The eligibility criteria also make sure people are safe while on a trial by taking into account any characteristics that might make your participation risky. For example, you may be excluded from a trial if you are pregnant, have high blood pressure, or have some other condition that significantly increases the risks of the treatment.
Before you join a trial, a doctor, nurse or other researcher will ask your permission. Informed consent is the legal term for the process through which participants are asked to confirm they have read and understood the purpose, risks and possible outcomes of the research before deciding whether to join.
The informed consent process includes:
- written information about the study, expected side effects and possible outcomes. This is called participant information. You can also talk to your doctors and/or clinical trials or research nurse about any aspect of the study.
- signing the informed consent form. For people under 18, a parent or guardian has to give legal consent. Signing the form is not a contract and you can withdraw at any time.
The process of providing informed consent continues throughout a study. If the study changes or new information becomes available while you are involved, you will be given new patient information and you may need to sign an updated version of the consent form.
Sometimes you may need to consent to each aspect of a study. For example, you might agree to take part in a trial of a new surgical procedure, and then need to consent for your tissue to be collected and banked during that surgery. You might be given an extra questionnaire, which may also require you to consent again.
Researchers must provide written information about the study to anyone thinking about getting involved. This is called participant (or patient) information.
It answers a range of questions about a study, including:
- the purpose of the study
- if it is a clinical trial, and what phase it is in
- who can participate in the study
- who is running the study (institution and researchers)
- who has approved the research
- who is funding the study
- how the study will be run and what you need to do
- whether you will need to have tests or other procedures
- how long you need to be involved for
- where you need to go for appointments, treatments or meetings
- whether your medical records need to be accessed
- whether you will be reimbursed for any related expenses
- information about possible side effects or other risks
- who to contact for further information or if you have any problems or complaints during the study
- information about your rights, such as keeping your records private and your ability to withdraw from a study.
Answers to some of these questions are provided in the informed consent document. The participant information can help people decide whether they want to enrol or continue participating in the study. You can also ask the research team any questions you have about the study.
All studies include a contact person. You can talk to this person before you decide to participate and at any stage during the study if you have questions or concerns. The contact person is often a clinical trials nurse or study coordinator.
You will also be given details of who to contact if you have a complaint about the study, for example, how it was run or how you were treated. This person is independent of the research team. Complaints about research are rare, but it is one of your rights as a participant to have your concerns heard if you have a problem.
Communicating with the treatment team
- Keep contact information handy if you have questions before and during the study.
- Sometimes a trial is run at a different hospital to the one where you’re having treatment. This means you may have two treatment teams. If this is the case, make sure your medical information and any relevant test results are available to both treatment teams, and ask who your main contact person is. It may also help to take your own record of test results to the hospital.
- If you are in a clinical trial and develop significant problems, go to your hospital’s emergency department and/or contact your hospital’s oncology registrar. If you go to hospital, let your trial team know.
Medical records are private and confidential, including those relating to your involvement in a trial or study. Health professionals directly involved in your care or study can access your personal and medical information, but only if it’s necessary for their work. They can’t disclose anything about you to others unless it is relevant to your health care or the study.
The participant information may mention who will and won’t have access to your personal data. For example, it might state that your regular medical team won’t have access to your questionnaire responses but the researchers will. You might be asked to consent to the research team accessing your existing medical records or particular test results.
Often, information collected during the study is de-identified. This means that it won’t have your name on it so the results cannot be linked to you. Not even the researchers know which results belong to which individuals. When the results are published in journal articles and the studies discussed at conferences, you will not be named.
For more information about privacy issues in health care, talk to the social worker at your hospital or call Cancer Council 13 11 20.
At the end of a clinical trial or other study, all personal information is stored securely for at least 15 years before it can be destroyed. This is a legal requirement.