Frequently Asked Questions
A carefully designed and supervised scientific research trial involving people. Clinical trials may involve treatment, such as drugs or devices, or an intervention, such as procedures or techniques.
The ultimate goal of cancer clinical trials is to cure cancer by finding better ways to:
Cancer clinical trials can cover all areas including:
The goal of treatment is to get rid of, stop, slow, or reduce the growth of your cancer. In clinical trials that use an intervention, the goal is usually to prevent cancer, detect cancer earlier, or improve symptoms.
Phase refers to the stage of development in the clinical research process.
The protocol describes how the clinical trial will be done. It is the research plan of action, like a recipe or instruction manual, describing the “who, what, when, where, why and how” of the clinical trial. It is carefully designed with strict instructions to protect patient safety.
It is very important for patients participating in a clinical trial know what is involved. The informed consent form is a paper form that contains all the facts about the trial, including the treatment, tests, possible side effects, benefits, contact person and many more details, to help you make an informed decision about taking part in a clinical trial. The consent form is discussed, read, and signed by the patient and the clinical trials research team.
You may bring a person to translate for you or we will provide a translator.
No. New techniques using radiation, surgery or devices are also tested in clinical trials. Older treatments being used in newer ways or new combinations of treatments are tested as well. Some clinical trials are conducted with treatments that are already approved to allow earlier access to these new treatments and/or to watch for any long-term side effects. There are also clinical trials that use interventions to improve cancer prevention, diagnosis, and treatment. As well, some clinical trials test ways to help improve symptoms and side effects.
No. It is a myth that clinical trials are only for people who have no other treatment options. There are many clinical trials for those who are newly diagnosed, those who have responded to previous treatments, those in remission, and those whose cancer has returned. You will be given all of your other options when you talk to your oncologist about clinical trials.
Your oncologist will discuss treatments such as radiation, surgery, chemotherapy, or other types of drugs which have been shown to help your type and stage of cancer. Sometimes no treatment is a good option; your condition will be watched with follow-up exams, blood work, and/or scans. Clinical trials simply offer another option for you to consider. You are the best person to decide what is best for you.
No. Clinical trials are highly regulated to ensure ethical treatment of patients. You will never be denied any standard treatment options available to you. Participation is always voluntary. You can withdraw from a clinical trial at any point in time for any reason.
There is a lot of information, especially when you first learn that you have cancer. Sometimes the informed consent form for a clinical trial is quite long. If you are feeling overwhelmed with all the information,
Not always. You have to be the right fit for the trial and the trial has to be the right fit for you. Each clinical trial has specific eligibility criteria, such as:
In order to protect your safety, you can only join a clinical trial if all of the necessary criteria are met.
Only if your oncologist is one of the doctors involved in the trial, i.e. an investigator, otherwise another oncologist at the Juravinski Cancer Centre who is an investigator trained in the trial will take care of you until you complete the trial. Your oncologist will be informed about your care and they will resume your care once you complete the clinical trial.
No. The oncologist and clinical trials research team want you to be aware of all of your treatment options. They will discuss any implications of saying no with you. They understand your right to make your own decision. Your decision will not affect the quality of your care.
Yes, if one of the many clinical trials we offer is the best option for you. If you are currently treated in a centre which offers the same clinical trial, you can be treated there. Occasionally, the best clinical trial for you may only be available at a nearby centre, such as Cambridge Memorial Hospital, Walker Family Cancer Centre, or Princess Margaret Hospital; in this case you would be referred there if you wish.
Your oncologist will discuss clinical trials options with you that they feel may help to slow or stop your cancer from growing or provide a better quality of life. However, the effectiveness of the new treatment is being studied and may not be known. This is one of the reasons the clinical trial is being offered.
Ask your doctor if there are any clinical trials that may be right for you. There are also things that you can do to become more informed about clinical trial options:
You will have assessments and medical tests at regular time-points to determine how well the treatment is working for you. The effectiveness of the treatment is determined by your cancer’s response, meaning whether you have:
A clinical trial may have more than one treatment group. The group that receives the standard treatment is called the control group; the group that receives the new treatment is the experimental group. There may be other groups that combine the standard treatment with the new treatment. You will always know your chances of being placed in any group.
In some cases when a new treatment is being compared to the standard care of simply watching over your health or when a new treatment is being added to a standard treatment, a placebo may be used. You will be told if a placebo is being used in the clinical trial and your chances of receiving placebo. Usually you, your doctor, and the clinical trials research team will not know if you are receiving placebo or actual treatment. This is called “blinding.” It is important to know that, in certain circumstances, such as a medical emergency, you can be “unblinded” to reveal whether you are receiving the actual treatment or placebo.
Used most often in Phase 3 clinical trials, you will be assigned randomly, like flipping a coin, to one of the treatment groups by a computer or number chart. This is done to make sure that patients are not chosen for either group in a way that could affect the clinical trial results. Neither you nor your oncologist will choose your treatment group.
Yes. The control group is very important for comparison to find out if the new treatment is better or not. You will have all the same assessments at the same times as those in the experimental group. If the new treatment turns out to be better, you may have a chance to switch over to the new treatment.
Once you have had time to make an informed decision about taking part, screening tests are performed to determine if you are eligible. On a Phase 2 or 3 clinical trial, you can start very soon after eligibility has been confirmed. Phase 1 trials enroll patients in small groups of 3 to 4 at a time so you may have to wait a few weeks for the next group of patients to be enrolled. The timeframe of starting the clinical trial will be discussed with you.
You are watched very closely while on a clinical trial and may have extra visits or longer visits. More tests and procedures may be done. Depending on the phase of the trial, you may have to stay all day or overnight for blood tests or a biopsy (for example, on a Phase 1 trial). You may have to fill out extra paperwork, such as questionnaires or pill diaries. You may need to have follow up visits or phone calls for several years after the treatment is complete (for example, on a Phase 3 trial).
Yes. You can stop participating in a clinical trial at any time for any reason and discuss your other treatment options with your oncologist. Withdrawing from a clinical trial will not affect the quality of your care.
There might be. You will be made aware of all the known side effects and risks when the informed consent is reviewed with you. Unexpected side effects are also possible. You will be watched very closely for side effects and will receive the needed medical care. You may have to pay for medications to control side effects depending on your personal drug coverage. You will be encouraged to call a contact number if you are concerned about new side effects between visits or after hours.
As a patient taking part in a clinical trial at the Juravinski Cancer Centre, you have the opportunity to:
You will be watched closely and if your cancer is getting worse or your side effects are not manageable the clinical trial treatment will be stopped and you will be offered other treatment options.
Yes, if other patients express an interest in talking to others on the same clinical trial. Each patient’s privacy is protected.
You will continue to be followed for the period of time that is stated in the protocol. Follow-up can range from a few months (e.g. Phase 1 trials) to up to several years (e.g. Phase 3 trials). The length of follow-up will be discussed with you. Direct contact with you during this follow-up period may or may not be required as sometimes the information needed for follow-up can be found in your medical records. After the necessary follow-up is complete, your care will transfer back to your original primary care team. During follow-up, you will still be provided with other treatment options and you can start a new treatment as soon as you and your oncologist feel you are ready.
It could be many years for all the patients to complete the clinical trial and for the data to be analyzed. Once the results are available, a paper will be published in a scientific journal. You will be kept informed with any new information about the clinical trial on an ongoing basis and may receive the results.
No. You are not paid to be in a clinical trial, however the treatment or intervention given as part a clinical trial is given free of charge. In some trials that have lengthy visits, parking may be paid for, but this is not guaranteed.
The treatment given on a clinical trial is given free of charge. You may have to pay for medications to control side effects depending on your personal drug coverage. Clinical trials usually have more frequent visits which means you will need to come in more often and meals are not provided. Parking may be an extra cost. In some trials that have lengthy visits, parking may be paid for, but this is not guaranteed.
Yes. Your medical information is confidential. Clinical trials are monitored by individuals from the sponsor, such as the drug company supplying the drug. The sponsor is always listed in the informed consent form. These individuals monitor the progress of the clinical trial and have access to your medical information. Health Canada may chose to inspect the clinical trial and would also have access to this information. Any individual that views your personal information is bound by law not to disclose your information. Any forms or computer entries recording your information identifies you by a code number and/or your initials. Your name or personal information will never appear at any external centre or in publications.