Research studies/Clinical trials FAQ
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.
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
In Phase I trials, researchers test a experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.