Joining a trial or study

There are many ways to find out about clinical trials and other research studies. Most cancer specialists know about current studies and may recommend you join a suitable study, or you can ask them if there are any trials you can consider. If your hospital has a clinical trials or research nurse, you can also ask them about current studies. You don’t have to join a study at your current treatment centre – your doctor can refer you to a suitable trial at another centre.

Hospital and treatment centre waiting rooms often have information about current studies, or you might hear about a study through patient  support groups, in the general media or through social media (such as Facebook). Before providing any personal information, especially via social media, check the study with your doctors.

You can also search clinical trials websites. If there isn’t a suitable study available right now, you can register through websites such as  register4.org.au and www.cart-wheel.org, and they will tell you about any studies that come up in the future.

If you find a trial or study you’re interested in joining, discuss it with your cancer specialist. You can ask them if you meet the eligibility criteria and, if so, whether they could coordinate your involvement or put you in touch with the research team.

You may have many questions when deciding whether to join a clinical trial. As well as talking to your doctor and clinical trials nurse, it is a good idea to talk to people close to you, such as your family, carers or close friends. Ultimately, though, it’s your decision to participate in research or not to participate.

You shouldn’t feel pressured to take part in research, and you should not feel rushed into making any decisions that may affect your health or treatment. Ask your doctor or nurse how much time you have to think about whether or not to join a study. You should usually be given at least a few days to consider the participant information. If you would like to take more time to think about it, ask if it is safe to wait a bit longer before starting treatment. If you decide not to join a study, you will still receive the standard treatment for the cancer, and it won’t affect your relationship with your treatment team.

Weighing up the benefits and risks

• Consider what is most important to you. Some people prefer to have standard treatment with predictable side effects, whereas others want to try something new even if the benefits are not yet proven or it may have unknown side effects.
• Think about how the study might affect your health, wellbeing and lifestyle. What is the chance of any serious side effects? Will any parts of the study be too difficult (e.g. having to have extra tests or trips to the hospital)?
• Weigh up these drawbacks and risks against the possible benefits, such as a possibly longer survival time or not having to experience certain side effects.
• Remember that everyone’s situation is different – what is the right decision for someone else may not be right for you.

Some people like to get a second opinion about whether they should join a research study, particularly if it is a clinical trial. A second opinion can:

• confirm or clarify your doctor’s recommendations
• help you to consider all the advantages and disadvantages of being on the trial
• reassure you that you have thought about the different issues that might affect you.

If you would like to get a second opinion, ask your general practitioner (GP) for a referral to another cancer specialist, but keep in mind that you may have to wait several weeks for an appointment and you may have to pay extra.

You can also ask your cancer specialist if it is possible to talk to another specialist within the same hospital or treatment centre. Some people also like to discuss the possibility of a trial with their GP.

Before any clinical trial or other research study begins, researchers develop the protocol for that study. This detailed plan describes the study’s design, the reasons for doing the study, and who can join (known as the eligibility criteria).

The eligibility criteria are the rules for who can take part in the research study. They outline the features that must be shared by all participants to ensure that the people taking part are similar in certain ways. This is so the results of the study will be clearly related to the treatment, not to other individual factors.

Depending on the research, the 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 treatments for the cancer
• other medical conditions.

Eligibility criteria can be broken down into:

• inclusion criteria – the features a person needs to have to join a research study
• exclusion criteria – the features that stop someone from taking part.

The eligibility criteria also help keep people safe by considering things that might make the trial too risky for them. For example, you may be excluded from a trial if you are pregnant, have high blood pressure, or have some other condition that increases the risks of the treatment.

Although there are thousands of different clinical trials occurring around the world at any one time, eligibility requirements can be very specific, and there may not be a trial suitable for your particular situation. For example, if you have metastatic cancer, the disease may have to be active or progressing for you to be eligible to join a particular trial.

Before becoming part of a clinical trial or other research study, all participants have to give “informed consent”. This means you will be asked to confirm you have read and understood the purpose, risks and possible outcomes of the research before deciding to join. Informed consent involves:

Written information – After talking to you about the study, members of the research team will give you a written document known as the participant information. This written information explains the purpose of the study, what is expected of you if you join, what the possible risks are, how your information will be used, and how the results will be presented. You should read the participant information carefully and note down any questions you have for your doctors and the clinical trials or research team.

Informed consent discussion – After you have read the participant information, you can discuss the study in more detail with the clinical trials or research team. You should ask them to explain any parts of the written information that seemed unclear to you.

Agreement in writing – Once all your questions have been answered, you can then decide whether or not to join the study. If you do choose to take part, you will be asked to sign the informed consent form. This confirms that you understand the purpose of the study, what is involved, the potential risks and benefits, and you agree to participate.

For some low-risk studies, written informed consent may not be needed. For example, if you are doing a survey, just completing the survey may be taken as consent, or you may be able to say you consent over the phone.

For people under 18, a parent or guardian has to give legal consent as well. Signing the form is not a contract and you can change your mind at any time. You will receive a copy of the consent form signed by you and the researcher.

The process of informed consent continues throughout the study. If the study changes or new information becomes available while you are involved, you will be given updated participant information. You will need to sign an updated version of the consent form if you are willing to continue.

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 also need to consent again if you are given an extra survey or interview.

Contact person

All clinical trials and other research studies have a contact person. You can talk with this person before you decide to take part 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 (e.g. about how the study was run or how you were treated).   This person is independent of the research team and is usually a senior member of the human research ethics committee. Complaints about research are rare, but it is your right to have your concerns heard if you have a problem.

Participant information

Researchers must provide written information about the research study to anyone thinking about joining. This is called participant (or patient)  information. It answers a range of questions about the 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
• how the study will be monitored
• whether you will need to have tests, scans or other procedures
• how long you need to be involved
• where you need to go for appointments, treatments or meetings
• whether the researchers need to see your medical records
• whether you will be paid back (reimbursed) for any expenses related to the study (e.g. transport or parking costs)
• information about possible side effects or other risks
• information about possible benefits
• any restrictions on things you can do while you are on the study (e.g. treatments you can’t have)
• who to contact for more 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.

Privacy

Medical records are private and confidential, including those about your involvement in a clinical trial or any other research 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 give any information about you to others unless it is relevant to your health care or the study.

Clinical trials and other research studies collect personal data about you. The participant information may mention who will and won’t have access to your personal data. For example, it might state that your regular treatment team won’t see your survey responses, but the researchers will. You might be asked to consent to the research team seeing your existing medical records or particular test results.

Information collected during the study is often de-identified. In most cases, this means that your name will be removed and replaced with a unique participant number so your identity cannot be revealed unless necessary, e.g. for safety reasons. Being de-identified means when the results are published in medical journal articles or discussed at medical conferences, you will not be named.

If you have questions or concerns about your privacy in a clinical trial or other research study, talk to the clinical trials or research nurse. For general information about privacy issues in health care, talk to the social worker at your hospital.

At the end of a clinical trial, all personal information is stored in a secure place for at least 15 years before it can be destroyed. This is a legal requirement.

What you need to do when you agree to join a clinical trial or other research study depends on what kind of research it is. Some studies need preparation and ongoing follow-up, others involve a single visit or just a survey.

Your participation is usually organised by one person (often a clinical trials or research nurse or research assistant), but you may come into contact with different members of the research team.

Finding out about the trial

• Your cancer specialist may suggest a trial to you, or you may find a trial through your own research.
• Discuss the trial with a member of the clinical trials team and your cancer specialist. You may also choose to see another specialist for a second opinion.

Checking you are eligible

• Answer some questions about your medical history and have a physical examination and any required tests, such as a CT scan and blood test, to check that the trial is suitable for you. This is known as screening.
• Once the clinical trials team has these results, they will let you know if you have been accepted into the trial.

Deciding to join

• Read the participant information. You may want to discuss the information with family, friends or your GP.
• Ask the trials team any questions you still have about the study, including questions about safety, side effects, financial issues, number of visits and timing.
• If your questions have been answered and you agree to take part in the trial, sign the informed consent form.

What to expect

• Expect that you may have less flexibility on the trial than you would with standard cancer care – for example, you may need to have blood tests or treatment on particular days. This may mean you need to adjust your work schedule or childcare arrangements more than you would if you were not involved in the research.
• Be prepared for more tests and visits to your doctor than you would normally have. This is to monitor your health and to see if and how the treatment is working.

During the trial

• Follow the instructions you are given about the trial – that means going to all appointments, having the required tests, taking medicines at precise times, and completing logs, surveys or interviews. This will help make the trial results as reliable as possible.
• Tell the research team about any side effects you are experiencing. The research team will ask about how you are feeling emotionally and physically.

After the trial

• Researchers may stay in contact with you and ask follow-up questions for some time after the trial. This will give them long-term information on how you responded to the trial.
• You may return to having the standard care and/or check-ups and tests that are appropriate for you, depending on the stage of the cancer and what your cancer specialist recommends. In certain circumstances, you may be able to keep having the trial treatment.

Communicating with the treatment team

• Keep contact details handy in case you have questions before, during or after the trial or study.
• If your clinical trials team has given you a participant card, keep this with you and show it to any other health professionals you see.
• If you join a clinical trial at a different hospital to the hospital where you started cancer treatment, you may have two treatment teams. In this 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.
• If you are in a trial and develop new or worsening symptoms, let your clinical trial and cancer care teams know immediately. If the symptoms are serious, go directly to your hospital’s emergency department and/or contact the oncology registrar at the hospital. It is important to tell the hospital you’re in a clinical trial and show them the participant card if you have one. If you go to hospital, let your clinical trials team know.

Many people wonder if they can keep having the experimental treatment after a trial is over. This depends on several factors, such as the trial phase  and results; how effective the treatment was for you; what the recommended course of treatment is; and whether the trial sponsor is prepared to continue providing the treatment.

Some people join clinical trials to get treatments that are not available anywhere else. It can be frustrating to have to stop a treatment after the study ends. When a trial shows that the experimental treatment works and has no major side effects, the treatment can sometimes be continued after the trial. Ask your doctor or clinical trials nurse.

Participating in research is voluntary and you can stop (withdraw) at any time. You may want to leave because you no longer have the time or energy for it; don’t feel it is helping; have side effects or your health is worsening; move away from the treatment centre; or change your mind.

If you do decide to withdraw from a clinical trial, you will receive the standard treatment that is currently the best option for you. You may be asked why you are withdrawing from the trial – you do not have to give a reason, but it can help the research team understand more about the needs of participants if you do. You may also be asked if the team can still collect some information about your health. This can help them learn more, but it is your choice.

It can take a while to get trial results. Usually results are available 2–5 years after the study finishes, but sometimes it can take 10 years or more. The results of most clinical trials will be published in medical journals and presented at medical conferences and scientific meetings.

If you’d like to know the results of the study you participated in, start by asking your doctor or clinical trials coordinator. The participant information you read at the beginning of the trial and the informed consent document you signed often say how and when the results will be available. The results are usually reported for everyone in the trial together, so you may not be able to see your individual results.

You may want to talk to your doctor about what the overall results mean. Sometimes the study results are shared with participants in an easy-to-understand document (lay summary).