Clinical Trials

Frequently Asked Questions

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Clinical Trials

Frequently Asked Questions

What clinical trials are available for participation at CCMB?

Contact your oncologist to see if you are eligible for an open trial

The Clinical Trials Unit at CancerCare Manitoba continually strives to make clinical trials available for all adult and pediatric cancer patients in the province. New trials are added throughout the year just as open trials conclude. We encourage all cancer patients and their family members to ask their physician if there is a trail suitable for them – only a doctor can refer a patient to a trial. To browse the complete list of open clinical trials at CCMB click here.

What are the advantages?

There are numerous potential patient benefits for trial enrollment

  • Treatment studies offer the most sophisticated, up-to-date, high-quality cancer care available as a new therapy is tested. At a minimum, the patient receives the best standard care currently available.
  • If a new treatment is successful, study patients receiving that treatment are the first to benefit.
  • Patients who take part in a study are actively helping themselves and future cancer patients.
  • Patients who participate in a trial become part of a network of clinical trials carried out around the country or the world. In this network, doctors and researchers pool their ideas and experience to design, conduct, and monitor clinical studies. They share their knowledge about cancer treatment and care. Patients in these studies receive the benefit of this expertise.
  • All patients are carefully monitored throughout treatment.
  • Exploring all the treatment options helps a patient feel more in control and more a part of a vitally important decision affecting their life.
  • Patients may withdraw from a study at any time.
  • Referral to a study need not end the continued relationship with the patient's primary care physician. This relationship is encouraged.
  • Studies provide free medication which saves money for the patient and the health care system.

What are the disadvantages?

Trials also have potential downsides that are important to consider

  • New treatments are not always more effective than the current best treatment. They may produce the same results. Occasionally the results are worse.
  • New treatments may produce unanticipated side effects or risks.
  • Not all patients in a study receive the new treatment. Some are in a group that may receive standard care for comparison to the new approach. Patients are assigned randomly to receive new or standard treatment, and some are uncomfortable with this requirement. It is important to remember that standard care means the best treatment generally available.
  • In certain trials, patients will not know whether they are receiving the new treatment being studied or the current best treatment. This blinded approach is a very important part of the scientific process that prevents the researchers from becoming partial to one conclusion over another.
  • There may be more visits to the clinic and more tests required for study purposes.

What is informed consent?

Helping you make an information decision about trial enrollment

Informed consent refers to the communication process that occurs to allow you to make an informed choice about participating in a clinical trial. The trial is explained in detail, including the treatment plan, all the possible benefits and known risks, required tests, frequency of visits, and other treatment options. You are encouraged to ask questions during this process.

You will be provided with an informed consent form to take home and consider away from the clinical setting. The form will contain specific information about your trial. If you decide to participate, the form should be signed in the presence of a research nurse.

Further tests may be required to determine eligibility.

How are trials conducted?

Detailed protocols are followed for all clinical trials

Researchers follow a carefully designed treatment plan called a protocol. This spells out the rules of how the treatment is administered, how many people will take part, what tests they will receive, and how often.

Generally, clinical trials compare two or more treatments. In most trials, an equal number of people are randomized to one treatment or another. The treatment choice is decided by chance, often by a computer. Participants go through their treatment and are followed along with everyone else on the trial, usually for several years, or for life. All symptoms, side effects, and the participant's progress are closely monitored.

Some trials are open-label. This means the participant receives the new treatment being tested, or the standard treatment and everyone is aware of which treatment is being given.

Other trials are blinded. In a single-blind study, the participant does not know which medication they are taking. In a double-blind study, neither the doctors or nurses following the participant nor the participant themselves know which medication they are taking.

Randomized and blinded trials eliminate bias in the selection of participants (having the study's results affected by human choices or other factors not related to the treatments being tested).

Sometimes placebos are used when the standard treatment is to just observe, or give no further treatment. A placebo is a tablet, capsule, or injection that looks like the drug being tested but contains no drug. Some patients will receive the new drug and others a placebo, to compare whether the new treatment works better than no treatment at all.

What protection do participants have?

Clinical studies are federally regulated to protect patients

The ethical and legal codes that govern medical practice apply to clinical trials. Clinical research is federally regulated with built-in safeguards to protect patients. Each protocol is approved by a Research Ethics Board which reviews the protocol to ensure that the research will not expose patients to extreme or unethical risks. All patients in clinical trials are carefully monitored and during treatment follow-up as applicable per individual protocol requirements.

Studies are planned to safeguard the medical and psychological health of patients as well as to answer research questions. If the treatment is not helping the patient, the doctor can decide to take the patient off the study. Also, if there is firm evidence that one method of treatment is better than the others in a study, the trial is stopped and all patients in the trial are given the benefit of the information.

How do I get involved?

Ask your oncologist if there’s a clinical trial for you

Each trial has its own set of eligibility factors, such as age, disease status, and past medical history. Your opportunity to participate in a trial also depends on whether a suitable trial is being conducted at a treatment centre accessible to you. Your doctor will discuss treatment options, including the best standard treatment available and the possibility of participating in a clinical trial.

If you are interested in participating, your doctor or a research nurse will review the details of the trial with you. Before starting a trial, a process called informed consent takes place. Participation in a clinical trial is always voluntary.