#TalkClinicalTrials: The Role of Health Canada in Protecting Clinical Trials Participants
The following blog post was submitted by Dr. Carole Légaré, Director, Office of Clinical Trials, Health Products and Food Branch, Health Canada.
Clinical trials offer you the chance to take part in research that could improve your health and that of others. There is often limited information available about the safety and efficacy of drugs used in clinical trials, especially for new drugs under development. This is where Health Canada plays an important role to help protect clinical trial participants.
Unless a clinical trial involves the use of a marketed drug for its approved indication, the sponsor of the trial (a drug company, hospital or physician) must file a clinical trial application with Health Canada and abide by the federal clinical trials regulations. Health Canada reviews the safety and efficacy information accumulated to date (this can include animal and human studies), the research protocol, the informed consent form (to ensure risks are disclosed) and how the drug is manufactured (to assess if it is of good quality). For some drugs, such as vaccines, Health Canada also conducts tests on samples.
Health Canada can object to a clinical trial if the information provided is insufficient, if it endangers the health of participants or other persons, if it is not in the best interest of participants or if the objectives of the trials are not achievable. The regulations also require that the clinical trial be reviewed and approved by a research ethics board before it can start. They require that serious unexpected side effects be reported to Health Canada and that the trial be conducted according to “Good Clinical Practice” which is an international ethical and scientific quality standard. Any change made to a protocol that could potentially affect patient safety must also be submitted to Health Canada for review.
All trials involving patients that were successfully reviewed by Health Canada are listed in Health Canada’s clinical trials database. People considering participating in a clinical trial can check this database to confirm that Health Canada did not object to it. Health Canada also has the power to inspect clinical trials, to verify if they comply with regulations and Good Clinical Practice. Should there be any concerns during a trial, Health Canada has the ability to suspend or cancel the trial.
As you can see, Health Canada plays an active role in protecting the health of Canadians who take part in clinical trials.
CTO wishes to thank Dr. Légaré for sharing this blog as a part of #TalkClinicalTrials, a campaign led by Clinical Trials Ontario with support from many voices to build awareness of clinical trials. Why? Because clinical trials matter to all of us. They help to generate better treatments and technologies and ultimately help shape the future of medicine.
Clinical Trials Ontario can help you navigate clinical trials
Are you thinking of engaging with clinical trials? We have tools and resources that can help. Use our Clinical Trial Finder tool to find open clinical trials in Ontario or across Canada. You can search by disease, location or demographics. Use our educational modules to learn more about what clinical trials are and what you should know before engaging with one.