Are clinical trials safe?

Clinical trials are carefully designed to ensure that there is as little risk as possible for participants. Pre-clinical work is conducted for many years in advance of a clinical trial (for example, on models, tissue samples, mice, etc.) to ensure that the new treatment is safe to test on humans.

All clinical trials conducted in Canada must adhere to the Food and Drugs Regulations, Division 5. Specifically, all clinical trials conducted in Canada must:

• Protect the health and well-being of the people that participate.
• Be overseen by trained professionals.
• Be closely monitored and side effects must be reported.
• Be reviewed and approved by a Research Ethics Board.

How are clinical trials designed?

A team of qualified specialists responsible for designing clinical trials includes: researchers, doctors, scientists, statisticians, sponsors, patients, and/or caregivers. The design of clinical trials may differ depending on various factors. Researchers begin by asking questions to establish the goals of the study, for example: “What do we already know about this health-intervention?”

Do clinical trials only study medications?

No. In addition to medications, clinical trials also examine many different types of health-interventions, including surgery, radiation, diagnostic processes, lifestyle, and more.

Where are clinical trials done?

There are many different settings for clinical trials, including hospitals, private companies, doctors’ offices, and community clinics.

What does “Phase” mean in the context of clinical trials?

Clinical trials are categorised into different phases:

Phase 1

The health-intervention (for example: a medication) is being tested on people for the first time. The purpose of Phase 1 trials is to establish that the medication is safe, to understand dosage, and to learn about any potential side effects. There are usually 20-80 participants in Phase 1 clinical trials.

Phase 2

Researchers want to learn if the health-intervention works as intended. This is also when the clinical trial team will learn more about side effects and determine if the dosage needs to be changed. There are usually about 100-300 participants in Phase 2 clinical trials.

Phase 3

Also called “randomised clinical trials”, these trials test how long the effects of the intervention last. The clinical trial team will also learn more about side effects during Phase 3 trials. There are usually thousands of participants in Phase 3 randomised clinical trials.

Phase 4

Also called “post-marketing surveillance” because this is the phase when the intervention (for example, the medication) is monitored after it is available on the market. During this phase, the trial team studies long-term side effects on a very large group of people.

You can learn more about the phases of a clinical trial here.

What does “randomisation” mean?

Randomisation is a process used to compare two or more health-interventions. In randomised trials, participants are randomly assigned (by chance) to receive one of the health-interventions (for example, the new treatment being tested, or the current standard of care).

What are placebos and are they used in cancer trials?

Placebos are inactive therapies that resemble active therapies. A common description of a placebo is a “sugar pill”. Placebos are very rarely used in cancer clinical trials because the new treatment is being compared to the current standard of treatment. Therefore, every person in a clinical trial for cancer does receive a real treatment (either the currently accepted treatment, or the new treatment being tested). In the very rare case that a placebo might be used, participants would be made aware during the informed consent process.

What is informed consent and how do I give it?

Participation in a clinical trial is completely voluntary. The informed consent process ensures that you are provided with all the information you need to decide if you want to take part in clinical trials. During this process, you should also be given the opportunity to ask questions, and discuss with the people in your life, to determine whether participation is right for you

An “Informed Consent Form” is a document that provides you with all the important information about the clinical trial. The research team will give you enough time to understand the consent form and ask any questions that you might have. Your medical team will help you to understand the potential benefits and possible risks, so that you can decide if you would like to participate in the trial. If you decide to participate in the clinical trial, you will be asked to sign the consent form and you should be provided with your own copy.

The informed consent process continues throughout the clinical trial. You can choose to withdraw from the trial at any time.

What is a “clinical trial protocol”?

Clinical trial protocols contain extensive information about the clinical trial. For example the protocol will explain why the trial is being conducted, how it will be done, how the data will be collected and analysed, how the results of the trial will be shared, and who is involved.