Who can participate in a clinical study?
All clinical studies have predetermined inclusion criteria as well as exclusion criteria that determine your eligibility for study participation. These factors enable the researchers to identify appropriate participants and to ensure safety throughout the study. People who have a specific condition being studied in a study can be eligible for a study. In addition, healthy volunteers also may take part in studies to test the drug’s effects and safety. Each study will have specific requirements that vary depending on the study objectives. As an example, medical condition, age and sex may be part of those requirements. Each volunteer’s medical history will be reviewed in light of the study requirements to determine if the volunteer is eligible. The Health Products and Food Branch (HPFB) of Health Canada has instituted very specific requirements for studies and who may participate, and Kendle Early Stage – Toronto stringently adheres to these requirements.
Each study defines a certain population of people by using customized inclusion and exclusion criteria. Inclusion and exclusion criteria are based on many factors, including age, medical history and current medical conditions. Study coordinators can often provide preliminary information over the phone regarding eligibility, but the best way to determine eligibility is by completing an examination with one of the physicians involved in the study.
