A choice that starts with
understanding.

A clinical research study is a type of research led by a physician (the study doctor), with the assistance of their staff, to evaluate the safety and effectiveness of investigational medications, medical devices, medical procedures or other health interventions. Investigational medications or devices tested in a clinical research study are often not yet approved for use in Canada, which means they are not available for general medical use.

A clinical research study may be conducted to evaluate the effectiveness and safety of an investigational medication, device or procedure for a given medical condition. This is often done by comparing the study medication to a placebo (see below) or to an approved medication, or by comparing different doses of a study medication. A study may also look at how a medication is handled in the body. The information collected can be used to seek approval to market a new medication or device, or to learn more about one that is already approved, for example its use in treating other conditions.

While participation in a study is entirely voluntary, not all volunteers are accepted into clinical research studies. Each volunteer must meet specific eligibility criteria for a given study, such as age, sex, type and stage of disease, other medical conditions and treatment history. These criteria exist to make the study results reliable: they reduce the chance that a result came from a change in the underlying disease, another medication, or other variables. Volunteers may also be turned away simply because the study doctor has already recruited enough volunteers.

By conducting clinical research studies, study doctors have the opportunity to:

• become more knowledgeable about scientific advancements in medicine
• contribute to the body of knowledge about diseases and their treatments
• gain experience with new investigational medications
• offer their patients the chance of receiving an investigational medication which may not otherwise be available to them

Physicians who take time away from their regular practice to participate in clinical research studies are paid for the work that they perform. Since it is not known whether a study medication or device will be found suitable by Health Canada to be marketed, the companies paying for a study must keep costs as reasonable as they can. The fees physicians earn are similar to what they would earn for performing services for other parties, such as completing forms and conducting physical exams for insurance companies.

There are various reasons for participating in a clinical research study:

• to receive an investigational medication which may not otherwise be available for a medical condition
• to learn more about your medical condition and receive additional study-related medical attention
• to learn more about the clinical research process
• to contribute to a greater understanding of a medical condition and its potential future treatment, for the benefit of others

Depending on the nature of the study, participation may be time consuming and, at times, inconvenient. There may be certain medications you will not be allowed to take while participating, and other restrictions. In addition, there are risks associated with all treatments and procedures. You must be informed of the known risks related to the study medication and study procedures, but there may be risks that are unknown or unexpected.

A placebo is sometimes referred to as a “sugar pill”, but it may also take the form of a liquid, spray or other formulation. The placebo resembles the study medication being tested. It is used for comparison: to see whether the study medication is more effective than no treatment at all. Not all studies include a placebo, and you must be informed if there is a possibility that you may receive one.

You will be given an informed consent form to review before any study-related procedures are performed. The consent form contains all of the information about the study: its purpose, the study medications involved and how they will be administered, known risks and potential benefits, the procedures required, the time commitment, and the duration of your participation. It also describes your rights as a research participant. If you wish to participate, you should understand all of the information in the form and ask the study doctor or staff about anything that is unclear. By signing, you document that you have been given information about the study and that you voluntarily consent to participate.

Health Canada and other government agencies set out laws and guidelines for the proper conduct of clinical research studies. They require that complete and accurate information about the study is given to participants and that participants’ rights and safety are protected. An ethics committee that is independent of the study doctor and of the company sponsoring the study must also review the study. The ethics committee helps ensure that ethical standards are applied and helps safeguard the rights, safety and well-being of all study participants.

You will be informed of the following during the informed consent process:

• the nature of the personal information to be collected
• the purposes for the collection of your personal information, its use and disclosure
• the method and duration of storage of your personal information
• your ability to access your personal information for review and to ask for corrections
• your right to challenge the handling of your personal information

You have the right to change your mind about participating even after you have signed the consent form. If you decide to withdraw, you should inform the study doctor as soon as possible. You will be invited to attend a final visit for closing assessments related to the study goals and your safety. There is no penalty or loss of benefits for withdrawing your consent.