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What are Clinical Trials?

A clinical trial or study is a carefully controlled way to research the effectiveness and safety of new treatments. By the time a treatment is ready for clinical trials, it has already undergone exhaustive testing in the laboratory and in studies with animals.

Clinical trials are conducted under the close supervision of doctors and other research professionals, and have been vetted by Health Canada. The trial is also reviewed by a Research Ethics Board (REB), an independent group of research professionals. The REB ensures that the trial meets the highest ethical standards and is conducted safely.

A common myth is that clinical trial volunteers are guinea pigs, or that clinical trials are used as a last resort. This is not true. If your doctor has recommended a particular clinical trial to you, then it may be the best option for your particular situation, or stage or type of cancer.

If you would like to participate in a clinical trial or learn more about whether a specific trial would be right for you, you should speak with your healthcare team about the benefits and risks.

How Clinical Trials Work

Types of Clinical Trials

Treatment Trials

Evaluate new or different approaches to treatment.

Prevention Trials

Focus on preventing cancer or stopping cancer from returning.

Diagnostic Trials

Identify new and improved tests or new procedures for diagnosing cancer or determining its stage.

Screening Trials

Evaluate ways of detecting cancer in the early stages.

Quality of Life Studies

Evaluate the effects of treatments on comfort and quality of life.

Phases of Clinical Trials

All clinical trials are assigned a phase. Only those drugs that meet the strict goals for safety and effectiveness may move on to the next phase. This process means that a drug that has just entered clinical trials can take up to five or more years to become commercially available for everyone.

Phase 1 (or I)

Phase 1 (or I) trials determine safe doses of a drug or a combination of drugs, how often it should be taken, and its side effects. These trials may also test the effectiveness of a different formulation of an existing drug or test the effects of an already approved drug on a different type of cancer.

Phase 2 (or II)

Phase 2 (or II) trials assess how effective a drug is against a certain type of cancer using the safe dosage determined in the phase 1 trial. Researchers may also compare the effectiveness of different dosages to each other. They will, of course, continue to monitor the safety and side effects of the drug.

Phase 3 (or III)

Phase 3 (or III) trials compare the new drug to the standard of care. The drug may be tested on its own or in combination with other drugs. These trials usually involve a large number of participants (hundreds to thousands) and are carried out at many different hospitals at the same time (a multi-site trial).

Phase 4 (or IV)

Phase 4 (or IV) trials are conducted once a drug has been approved by regulatory bodies such as Health Canada. Researchers gather more information about the drug’s effectiveness and side effects with longer-term use in a real-world clinical setting. Phase 4 trials also involve a large number of participants, sometimes including those who took part in phase 3 trials of the drug.

Risks & Benefits

Some risks and benefits will be unique to your specific clinical trial, but some factors are common across all trials. When you participate in a clinical trial, you can play a more active role in your care and help others by contributing to medical research. A clinical trial will give you access to new experimental treatments before they are widely available. You will receive expert care from medical professionals at top healthcare facilities.

On the flip side, because the treatment you receive will be new and experimental, it may or may not be more effective than the standard of care—that is, the best available current treatment. This treatment may also have unknown side effects, which may or may not be worse than those of the standard of care.

A clinical trial may also place greater demands on your time. The clinical trial team may want to monitor you very closely and ask you to visit more often or to stay at the healthcare facility. You may have to follow a more complicated treatment regimen or undergo extra tests.

Choosing to participate in a clinical trial is a big decision. Talking to your healthcare team and equipping yourself with the pertinent information can help you make this decision and feel comfortable with it.

Questions to Consider Before Participating in a Clinical Trial

People should know as much as possible about the clinical trial and feel comfortable asking questions to members of the healthcare team.

Following are some questions that might be helpful for the participant to discuss with the healthcare team. Some of the answers to these questions are found in the informed consent document.

What is the purpose of the study?
Who is going to be in the study?
Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
What kinds of tests and experimental treatments are involved?
How do the possible risks, side effects, and benefits in the study compare with my current treatment?
How might this trial affect my daily life?
How long will the trial last?
Will hospitalization be required?
Will I be reimbursed for other expenses?
What type of long-term follow up care is part of this study?
How will I know that the experimental treatment is working? Will results of the trials be provided to me?
Who will be in charge of my care?

Informed Consent

The informed consent form is a resource that can help you evaluate the risks and benefits of a clinical trial. Informed consent is part of the ethical standards followed by clinical trials. In addition to the risks and benefits, this document contains important details of the study, such as treatments, tests, side effects, duration, and who to contact if you have questions.

If you choose to participate in a clinical trial, you will have to sign the informed consent form. You will also have the right to withdraw consent and remove yourself from the clinical trial at any time.

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To learn more about clinical trials and the options that might be available to you:

Canadian Cancer Clinical Trials Network

This site also offers a Clinical Trials Navigation feature to help you search and connect to clinical trials that you or a loved one may be eligible for.

Canadian Cancer Clinical Trials Network

Canadian Cancer Trials Group

Health Canada

Clinicaltrials.gov

Canadian Cancer Trials

canadiancancertrials.ca