A Beginners Guide to Clinical Trials

What is a clinical trial?

A clinical trial is a research study of a new drug or procedure that has not yet been approved for use in general medical practise. Clinical trials allow pharmaceutical companies, biotechnology companies and hospital researchers the opportunity to test drugs and procedures for safety and effectiveness. All drugs and procedures that are currently available have been through the clinical trial process. Without clinical trials, it would be impossible for new medical procedures to exist

What happens before a clinical trial?

Before a clinical trial is conducted, researchers perform extensive laboratory testing on animal and human cells. They may also conduct research on animals. If the the laboratory work is successful, the researchers will then seek to initiate a clinical trial, which uses human volunteers.

How do clinical trials work?

Typically, a clinical trial has four phases:

Phase I: A phase I study is usually very small, requiring only a few volunteers. It is mostly concerned with the drug’s safety, and determining the best way to provide it (injection, orally etc.) It is also used to help determine the correct dosage of the drug.

Phase II: A phase II study begins to test the drug or treatment for its effectiveness. A phase II study will be larger than a Phase I study.

Phase III: This stage of the clinical trial process requires the largest number of volunteers, and is often used to compare the new drug or treatment with existing drugs or treatments, to determine if the new procedure is better than the existing one. This phase usually requires thousands of volunteers, and often requires several years before all of the data is collected and analyzed.

Phase IV: Phase IV usually occurs once a drug or treatment has received approval from the government, and is available to the public. Researchers continue to monitor the drug for long-term effectiveness, possible side-effects, and its impact on quality of life.

Why would I want to volunteer for a clinical trial?

There are several reasons to participate in a clinical trial:

• You may get access to a new drug long before it is available to the public. This is especially useful if you have not responded well to existing treatments
• Typically, a volunteer in a clinical trial receives more medical attention, more lab tests, and will be closely monitored by researchers, who are often leading specialists in their field
• You will have the satisfaction of performing an important service to the community by helping to further medical research

Are there any reasons not to volunteer for a clinical trial?

Yes. Some of the reasons not to participate are:

• You may suffer from unintended, and possibly dangerous side-effects that the drug produces
• The new drug/treatment may not be any more effective than the previous drug/treatment
• You may be placed in the “control group”, meaning that instead of receiving the new drug, you may get a placebo

How do I know if I can participate in a clinical trial?

Every clinical trial has strict rules about who can participate. These rules are called the inclusion and exclusion criteria. For example, a trial may need to exclude anyone who is pregnant, or who is already using a certain drug. myhealthCANADA provides inclusion and exclusion criteria for each trial listed on the website. You should read them carefully to determine if you may be eligible. If you believe that you meet the listed criteria, it is essential that you discuss the trial with your family doctor or specialist. Your doctor can double-check to make sure you meet the inclusion/exclusion criteria, and also help you to understand the potential risks and benefits of participating. You may then contact the trial coordinator, who will provide you with further information. Keep in mind, that even if you meet the inclusion/exclusion criteria, there is no guarantee that you will be selected for the clinical trial.

Are clinical trials regulated by anyone?

Yes. The government has rules and regulations governing clinical trials. You can get details about these laws at the Health Canada website at http://www.hc-sc.gc.ca/ or by calling (613) 957-2991. You should also know that all clinical trials conducted in Canada are reviewed by an ethical review board (sometimes called an institutional review board, or IRB). These boards are usually comprised of both doctors and laypeople, who examine the clinical trial procedures to ensure that the trial is conducted appropriately, ethically, and to protect patients’ rights. Keep in mind that this does not guarantee that the trial will be completely safe with no side-effects, but it does mean that the trial is monitored for overall safety, and compliance with the law. myhealthCANADA only lists trials that have received approval from an ethical review board.