Clinical Trials

Getting involved in a trial:
What do I need to know about clinical trials?

Here are some key things to know about clinical trials. Always talk to your doctor or the research team if there’s anything about a study that you don’t understand.

You must meet the eligibility criteria for a clinical trial.
Every clinical trial has eligibility criteria – guidelines for who can participate in the study. These criteria may include you or exclude you from the study on the basis of:

• your age and sex
• the type of condition/disease you have
• the stage of your condition/disease
• whether your condition/disease has worsened
• whether you have already received treatment for your condition/disease

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You must give your consent to participate in a clinical trial.
Informed consent is the process by which you learn about the details of a clinical trial, then decide whether or not to take part. Your doctor, or a doctor or nurse from the research team, will explain the clinical trial to you and give you a consent form – a document that describes the study in detail. If you agree to participate, you sign the consent form and return it to your doctor.

The consent form should explain:

the purpose of the study
the length of the study
the approach of the study (randomized, blinded, double-blinded, or other)
who is eligible to participate
what is already known about the treatment
the possible risks and benefits of participating, based on what’s known about the treatment
what medical tests and appointments will be involved
who is responsible for costs if you need extra care as a result of participating
who is responsible, and in what ways, if you’re harmed by the treatment
that your identity will be protected
that you are participating voluntarily
that you can leave the study at any time and still receive appropriate standard treatment
whom to contact if you have questions at any time during the study
whom to contact in case of emergency during the study

Before you sign the consent form, make sure you understand what’s involved in the study and what’s expected of you. Don’t be afraid to ask questions, to take the form home for review, to talk things over with your loved ones, or to get a second opinion from another doctor. Be well informed, take your time, and make the decision that’s right for you.

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You will probably not receive a placebo.
Placebos – inactive or “dummy” pills – are very rarely used in clinical trials for cancer research. In other kinds of medical research, placebos may be used to see if a new treatment works better than no treatment, if a proven treatment is not available. It would be unethical to give an inactive medicine to someone if a known treatment for the illness exists. So placebos are used in clinical research only if no proven treatment exists or in combination with proven treatments.

In the first case, when no proven treatment exists for certain conditions/diseases, placebos may be used to study whether a new treatment works better than placebo treatment or no treatment. In the second case, when combination treatments are studied, placebos may be used to see if two treatments together work better than the current standard treatment alone. In combination studies, all participants, even those receiving placebos, are guaranteed to receive at least the standard treatment already in use for their type and stage of condition or disease.

The consent form for any clinical trial will clearly state whether a placebo will be used in the study, and how this may affect you if you participate.

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You must be an active participant in a clinical trial.
Depending on the size and type of the study, you may be treated directly by members of the research team, or by your regular health care team, who will report back to the researchers. In either case, you can expect to receive excellent care. The doctors and nurses will watch you very closely to see how you respond to the treatment, and their primary concern will always be for your safety.

In return, it’s important for you to follow the team’s instructions and take the treatment exactly as directed. You may have more tests or more appointments than if you receive conventional treatment, or you may even be hospitalized. You may also be asked to complete a treatment log or questionnaires. Members of the team may want to follow up with you after the trial ends. Requirements like these will be explained before you consent to participate in a clinical trial.

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You have rights and protections. You can withdraw from a clinical trial at any time.
Clinical trials are governed by the same legal and ethical codes that regulate all medical practice. Every clinical trial is observed by the Research Ethics Board. From the beginning of the trial to the end, the committee makes sure the risks of the study are reasonable in relation to the potential benefits.

You have the right to withdraw from a clinical trial at any time, for any reason, and without jeopardizing your care. You can leave before the study begins, during the study, or during the follow-up, after the study ends. You can leave even if you have signed a consent form. Signing a consent form indicates that you understand the study and its risks, and that you agree to receive the treatment. It does not mean that you are obligated to complete the clinical trial. If you withdraw from a clinical trial, you’ll receive the current standard treatment for your type and stage of cancer.

Your medical and personal information will be kept confidential. The research team will assign a number to your file to identify you, and your name will never be used in any publications about the study.

Researchers may stop a clinical trial at any time, or you may be asked to leave a study.
Ensuring patients’ safety is the most important part of a clinical trial. The research team may stop a study if it becomes clear that the experimental treatment is harmful or that another treatment is significantly better. The team may decide to remove you from a clinical trial if you have serious side effects from the treatment, or if the treatment doesn’t seem to be working for you.

 

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