Close

Clinical Research in Oncology

Find a Clinical Trial

Learn more about clinical trials

Is participating in a clinical trial in oncology an option for me?

Learn More

How are drugs made?

Several steps are necessary for drug development.

1. Laboratory Research
Discovery of the M-XX molecule
that could become a drug to treat cancer
1. Laboratory Research
2. Preclinical Research
Evaluation of the M-XX molecule
in animals
2. Preclinical Research
3. Clinical Trials
Evaluation of the M-XX molecule in humans

Phase 1: What is the safe dose?

Phase 2: Is M-XX effective?

Phase 3: How does it compare to the best available treatment?
3. Clinical Trials
4. Health Canada Approval
Review and approval
(or not) of M-XX as a new drug to treat cancer
4. Health Canada Approval
5. Manufacturing and Distribution
The new drug is now available

Phase 4: What happens in the long term?
5. Manufacturing and Distribution

Are you familiar with the 4 phases of clinical trials in oncology?

Phase 1 : Is it safe?

In general, only a few people with cancer are recruited. They often suffer from advanced cancer and have generally received all available treatments that can be offered.

Phase 1 is used to determine whether an experimental treatment is safe for patients.

More specifically, it is about finding the highest dose of treatment that can be given without serious adverse reactions.

The goal might also be to:

  • Find the best way to administer the experimental treatment, for example, orally or intravenously.
  • Check for signs that the cancer is responding to the experimental treatment.

Phase 2: Does it do what it is supposed to do?

Usually, a group of patients with the same type of cancer receives the experimental treatment.

Phase 2 is to test the efficacy of the product and determine the optimal dose.

In some studies, patients may be randomly assigned to different treatment groups. These groups may receive different doses or follow treatment in different ways to determine what is safest and most effective.

The goal might also be to:

  • Observe the first signs of cancer control that may maintain or prolong remission and delay possible recurrence.

Phase 3: How does it compare?

Most Phase 3 clinical trials are conducted with a large number of patients who have the same type of cancer or, more rarely, with patients who have different types of cancer.

Phase 3 is used to compare the experimental treatment with the treatment usually used (called “reference treatment” or “standard treatment”).

Phase 3 trials are comparative trials.

Most of the time, two or more groups of patients are randomized: one will receive the reference treatment and the other the experimental treatment.
It is not the doctor who decides which of the treatments his/her patient will receive.

Key points of Phase 3 clinical trials:

  • Placebos (inactive / false-treatment) may be used in some phase 3 studies, but they are never used alone if there is effective treatment.
  • Evaluate whether people who receive the experimental treatment are living longer than expected without treatment or are improving the quality of life.
  • As in other studies, patients participating in Phase 3 clinical trials are closely monitored for adverse events. If there are too many, or if the treatment is not effective, the study is interrupted.

Phase 4: What happens in the long term?

Once a new treatment is approved and available to the entire population, its long-term effects are studied.

How am I protected during a clinical trial?

Many measures are in place to protect clinical trial participants. Every effort is made to minimize the risks. The following is a list of these safeguards to ensure the safety of clinical trial participants.

Good clinical practice

Good clinical practice

The research team must ensure compliance with good clinical practice during the course of the trial. These rules ensure the protection of the participants and the quality of the results of the test.

Health Canada Regulations

Health Canada Regulations

Researchers must conduct their clinical trials in accordance with the law. This includes allowing inspections to ensure compliance with regulatory requirements.

Scientific and medical surveillance

Scientific and medical surveillance

It allows to stop the test if the expected benefits are not there, or if the adverse effects are more harmful than expected.

Informed consent

Informed consent

The participant consent process includes the use of an informed consent form that clearly explains the clinical trial, benefits and anticipated risks and describes the rights and responsibilities of the participants.

Research Ethics Board

Research Ethics Board

The Research Ethics Board evaluates and authorizes clinical trials before they begin and continue until they are completed.

HAVING TROUBLE FINDING WHAT YOU NEED?

Experienced nurses from the Quebec Cancer Foundation and information specialists from the Canadian Cancer Society can help you:

1800 363-0063
infocancer@fqc.qc.ca
1888 939-3333
info@sic.cancer.ca

917, rue Monseigneur-Grandin,
bur. 300, Québec (QC) G1V 3X8, Canada