Clinical trials that are well-designed and well-executed offer excellent opportunities for eligible participants to:
• Play an active role in their own health care.
• Obtain referrals to a study site.
• Engage care partners as companions in care.
• Gain access to new research treatments before they are widely available.
• Obtain expert medical, sometimes multidisciplinary, care at leading health care facilities during the trial.
• Help others by contributing to medical research.
• Enhance personal knowledge of a medical condition.
There are risks to clinical trials.
• Depending on the study design, there may be no guarantee that the participant will receive the active ingredient.
• There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
• The experimental treatment may not be effective for the participant.
• The research may require collection of data, for example, genetic information, that could potentially cause psychological or informational harm.
• The research criteria may require lifestyle modifications, for example, dietary changes.
• The protocol may require more of the participant’s time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
• The experimental drug may not be approved by Health Canada and, if approved, may not be covered under provincial drug formularies.