Clinical trials are a type of biomedical research that is conducted to help doctors and researchers learn more about health, diseases, and effective treatments in order to improve healthcare and understanding for future generations. There are many types of clinical research that include:
Before a clinical trial is open to the public for participation in Canada, it must go through a rigorous approval process from both the governing regulatory body (Health Canada) and Research Ethics Board (REB). The number one objective of this approval process is to ensure the safety of potential research participants.
Once the trial is approved, recruitment can begin and eligibility will be evaluated by the research staff for each willing participant. However, prior to anything happening, informed consent must be given by the participant. The informed consent process involves reviewing all of the study information with a member of the research team and having any questions or concerns that you may have answered to your satisfaction. If you decide to participate in a clinical trial, the Informed Consent Form (ICF) must be signed and will be provided for your personal records.
Did you know that in Canada, all health claims made by a product (including natural health products) must be backed by clinical research that proves the statement is true?
We are fortunate to have these standards as consumers and health professionals. You can rest assured that when you see a marketing health claim on a licensed product (look for an NPN or similar), there must be supporting research.
What to get involved? Clinical research is always being conducted for all types of natural health products and dietary supplements, not just pharmaceutical drugs. You can help by looking for clinical trials in your area that you are comfortable with or that you personally find interesting. By participating you will be contributing to a high standard of consumer protection, scientific knowledge and most trials compensate participants for their time!
dicentra will be recruiting participants for upcoming clinical trials of natural health products in the Toronto area shortly, stay tuned for updates!
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dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products.