Frequently Asked Questions
What is a Clinical Trial?
A clinical trial is a research study that investigates the safety and efficacy of a medication, medical strategy or medical device. By exploring medical strategies, research studies can help to determine which medical approaches work best for particular people or illnesses. Clinical trials are also conducted to allow an approved drug to be used for a new indication. Studies are necessary to further medical science by allowing researchers the opportunity to test drugs, devices and procedures for safety and effectiveness. Development and licensing of drugs in Canada involves four phases of study. The complete process can take up to 15 years. All drugs and procedures that are currently available have been through the clinical trial process.
Why should I participate in a Clinical Trial?
Each year, thousands of Canadians choose to participate in clinical research. For many, it provides an opportunity to access treatments that would otherwise be unavailable and also provides hope to those who have not responded well to existing treatments. Participants may benefit from the careful supervision and management of their condition, receiving extra study related care. Individual reasons for participating in a clinical trial may vary. Many people are interested to learn more about their specific condition and possibly improve their own health or quality of life. Some people appreciate access to medical care and medications that they may not otherwise be able to afford. Most often, individuals recognize their efforts and participation in an altruistic light. By contributing to clinical research, you are giving back to society, helping future generations and advancing medical science. The decision to participate in research is a personal one but one thing is for certain, volunteers are an integral part of the regulatory process and are essential for the advancement of medical science.
Click here for more information from the Center for Information & Study on Clinical Research Participation
Are there any costs to participate in a Clinical Trial?
The only cost to participate is your valuable time. You may be required to visit the clinic more frequently at the start of a study, usually once or twice per month, and less frequently thereafter for the duration of the study.
Will I be paid or reimbursed for participating?
Participants are reimbursed for their time, travel and parking costs. We appreciate our patients contributions to furthering our clinical research and make every effort to ensure any necessary accommodations are met.
how are my rights and health protected?
Clinical research studies are extensively regulated by health authorities, including Health Canada and the FDA. Strict guidelines and safeguards exist to ensure the protection of study participants. Every study conducted in Canada must first have its protocol approved by the Health Products and Food Branch of Health Canada. Each research study must go through a review process completed by independent Institutional Review Boards or an Ethics Committee. Their purpose is to ensure that the clinical trial is designed and conducted ethically with regard for the safety and rights of the study participants. Any personal information collected during the study is kept strictly confidential and your privacy is protected, just as it is with your family doctor.
what are the potential benefits or risks?
Medications can sometimes have side effects and different studies may carry different risks. Your study coordinator and study doctor will explain any potential risks and benefits before you make the decision to participate in a trial. During a study, you may receive an active treatment or you may receive a placebo, which is an inactive treatment. Generally, neither you nor your study coordinators or doctors will know which treatment you are receiving. Regardless of which treatment group you are in, you will receive the same high standard of study-related care.
what is the first step?
The first important step to participating in a clinical trial is the consenting process. You will be asked to attend a clinic visit to discuss the study in detail with the research staff. This is an opportunity for you to ask questions and learn all the important information about the study. During this visit you should discuss and consider:
- The purpose of the study
- The potential risks and benefits of participating
- The treatments, procedures and/or tests required during the study
- The study visit schedule and your availability
- Your obligations as a study participant
You should receive satisfactory answers to all of your questions and feel comfortable with proceeding before agreeing to participate and signing the informed consent document. Once your consent has been obtained, a screening or baseline clinic visit will be arranged. If the study doctor is not your family physician, it is common practice to ask your permission to contact your family doctor to notify him or her of your participation in the study. It is also important for you to bring a list of all medications you are currently taking and be prepared to answer questions regarding your medical history. Subsequent clinic visits will follow a schedule as outlined in the study protocol.