Information on Clinical Trials

Clinical Trials

Clinical trialsWhat is a clinical trial?

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, a natural health product, a 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.

Are clinical trials safe?

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 well-being of participants is 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 the risk and benefit analysis are performed before reaching a final decision. It is important to note that no treatment is completely safe for everyone; however, a clinical trial helps make sure that risks to the people participating are minimized to the greatest extent possible.

Who can participate in a clinical trial?

Clinical trialsPeople 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”. The 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.

How can I find a clinical trial?

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.

  1. Select from either “Recruiting and not yet Recruiting Studies” or “All Studies” depending on if you would like to see only currently active studies or all studies – both active and non-active.
  2. Type in what condition or disease you are inquiring about (i.e. NASH, Liver Cancer)
  3.  Add any other key terms you may find helpful (i.e. drug name, researcher name)
  4. Under “Country”, select Canada
  5. A second drop-down choice of “City” will show. Type in your city. On the right, there is also a “Distance” choice where you can add maximum distance (in miles) from the city you have chosen.
  6. Click “Search”
  7. Based on your search criteria, many trials will be shown on the page. You can click on the specific study title of an active “Recruiting” trial to obtain more details about the specific clinical trial.
  8. If you are interested in participating in a clinical trial, please speak with your health care professional to see if this is an option for you.

Sometimes, clinical trial terminology may be difficult to understand, speak with your health care professional if further clarification is required. If you are experiencing difficulties navigating the ClinicalTrials.gov website and require assistance, please contact the CLF National Help Line 1-800-563-5483.

Health Canada’s Clinical Trials Database [Internet]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/health-canada-clinical-trials-database.html 
Clinical Trials Ontario. Learn more about clinical trials [Internet]. Clinical Trials Ontario: Toronto; 2019. Available from: https://www.ctontario.ca/patients-public/learn-more-about-clinical-trials/
ClinicalTrials.gov. For Patients and Families [Internet]. U.S National Library of Medicine: Maryland; 2015. Available from: https://clinicaltrials.gov/ct2/help/for-patient#learnabout