A clinical trial is a research study that tests new ways to prevent, detect, treat, or manage various health conditions and diseases. The treatment may be a pharmaceutical drug, genetic therapy, natural health product, medical device, psychotherapy, or even a lifestyle and preventive care intervention. A clinical trial helps answer important questions about what works best for people and encourages further research in various health fields.
Yes, clinical trials are safe. All researchers looking to start a clinical trial must submit an official application to be reviewed and approved by the Health Products and Food Branch (HPFB) of Health Canada in order to proceed with the clinical trial.
Each study submitted is reviewed extensively and approved by a separate panel of medical doctors, researchers, and members of the community called the Research Ethics Board (REB) along with the HPFB of Health Canada. The REB’s role is to make sure that the study is ethical and that the rights and wellbeing of participants are protected.
Tests are conducted in a controlled environment where procedures and results are closely tracked, monitored, and analyzed by experts who specialize in their specific condition. The drug’s efficacy (ability to treat effectively) and safety are evaluated, and a risk-benefit analysis is performed before reaching a final decision. It is important to note that no treatment is completely safe for everyone; however, a clinical trial minimizes risks to the people participating to the greatest extent possible.
People volunteer to participate in clinical trials. In many studies, the researchers seek volunteers who are healthy or who have common health conditions, such as fatty liver disease, liver cancer, or Hepatitis B.
Each research study has its own guidelines about who can or cannot participate. This is called “eligibility.” The factors that allow someone to participate in a clinical trial are called “inclusion criteria,” and the factors that disqualify someone from participating are called “exclusion criteria.” Eligibility is based on characteristics such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Sometimes certain characteristics, such as age or gender, may prevent people from participating.
There are many clinical trial opportunities in Canada, and new ones are developed every day. Your healthcare professional may be aware of opportunities in your geographical area.
For a current list of clinical trials, please visit: ClinicalTrials.gov.
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