Joining a trial or study

Finding 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 the Center for Analysis of Rare Tumors, 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.

Deciding to take part

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.

A clinical trials nurse accompanied me at every stage of the process. She explained what was happening and answered any questions I had.

Marg

Eligibility criteria

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.

Informed consent

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:

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 (see below) and your ability to withdraw from a study.

My doctor suggested I take part in a study, and I thought it sounded beneficial. I found the thorough disclosure of both the trial and the possible side effects reassuring.

Piers

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 or see Protecting your health information.