Clinical Trials: Q & A

What is a clinical trial?

A clinical trial is a well designed study that is done with people like you who volunteer to receive investigational treatments under close supervision by a physician and other research professionals. Pharmaceutical and biotechnology companies have developed these treatments and they have selected physicians, also called investigators, who are qualified to conduct clinical trials. It is through these trials that important new drugs can show their potential benefits.

The clinical testing of a new drug is a step-by-step process that ensures you receive careful medical attention. All clinical trials are conducted with the approval of Health Canada’s Therapeutics Branch and the oversight of Ethical Institution Review Boards (ERBs).

ERBs are independent committees whose job is to make sure your rights are fully protected and that you are not exposed to any unnecessary risks. ERBs also are responsible for ensuring you sign an informed consent form before agreeing to participate in a trial. Clinical trials usually are conducted in three phases (I, II & III). A small number of healthy volunteers participate in Phase I trials to ensure the medication is safe to progress to disease states in larger population and longer term trials (Phase II & III).

In a clinical trial, a volunteer is usually assigned a specific study group. Sometimes volunteers in one study group will receive a new treatment or study drug while others may receive a placebo (dummy pill) or comparator medication (another pre-approved medication on the market to use in comparison to the study drug).

A placebo is a harmless, inactive product used to provide a baseline comparison to the active treatment to determine efficacy and tolerability. You, your physician, and your research staff will be blinded to who is on what treatment – commonly referred to as a double blind clinical trial.  This reduces any bias that research staff may have if we knew what medication the participants would be receiving.  Whether you receive the placebo or the investigational drug, the level of medical attention and care that you receive is the same.

Why are clinical trials conducted?

  • To see if a new drug or device is safe and effective for people to use
  • To compare existing treatments to determine which medication is more effective
  • To study different ways to use standard (approved) treatments, so that they will be more effective, easier to use, and/or decrease side effects

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study. The factors that allow volunteers to participate in a clinical trial are called “inclusion criteria’ and the factors that disallow volunteers from participating are called “exclusion criteria.” These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Inclusion and exclusion criteria are used to identify appropriate participants, promote participants safety, and ensure that researchers learn the information they may need to approve a study drug.

How does a clinical trial work?

In a clinical trial, a volunteer is usually assigned a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while the other volunteers may receive a placebo or a treatment already available.

A placebo is an inactive product used to assess the experimental treatments effectiveness. The participant, physician, and research staff may not know which volunteer receives a placebo and which receives the active treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteers during the study. Regardless of which treatment volunteers receive, however, the level of medical attention and care that each receives is the same.

What questions should be asked before choosing to participate?

Patients considering participating in a clinical trial should talk about it with their physicians and medical caregivers. Potential volunteers should also understand the credentials and experience of the staff and the facility involved in conducting the study. Questions to ask a physician or medical caregiver:

  • How long will the trial last?
  • Where is the trial being conducted?
  • What treatments will be used and how?
  • What is the main purpose of the trial?
  • How will patient safety be monitored?
  • Are there any risks involved?
  • What are the possible benefits?
  • What are the alternative treatments besides the one being tested in the trial?
  • Who is sponsoring the trial?
  • Do I have to pay for any part of the trial?

What is informed consent?

CLICK HERE for information from Health Canada regarding informed consent.

What are the benefits and risks of joining a trial?

Volunteers in a clinical trial participate in the development of medical therapies that may offer better treatments and even cures for life-threatening and chronic diseases. However there are risks involved.

Possible benefits for volunteers:

  • Play an active role in their health care
  • Gain access to research treatments before they are widely available
  • Obtain medical care at health care facilities during the trial
  • Help others by contributing to medical research

Possible risks for volunteers:

  • There may be unpleasant, serious, or even life-threatening side effects to experimental treatment
  • The experimental treatment may not be effective
  • The protocol may require more time and attention then a non-protocol treatment, including trips to the study site, more treatments, hospital stays, or complex dosage requirements

Please note: volunteers may withdraw from a study at any time for any reason.

Does information remain confidential and private?

Access to personal information is usually available to the investigator and research team conducting the clinical trial. In some circumstances, the ERB overseeing the research, government agencies and the sponsor or contract research organization coordinating the trial will also have access to personal information. All parties have to abide to local and country laws pertaining to patient confidentiality.  As a clinical trial progresses, researchers may report the results of the trial at scientific meetings, to medical journals, and to various government agencies.

What can I expect once I’ve joined a trial?

Once you have enrolled in a study, your medical history & medications will be reviewed and a physical examination will be performed to assess your current health status. A detailed description of your specific clinical trial and what’s expected of you will be outlined in the study specific informed consent document.

Physicians and healthcare professionals that conduct clinical trials are committed to providing you with excellent patient care and careful medical attention. You should feel free to discuss your medical treatment with your investigator or any research staff member at any time during the course of your clinical trial.

Your safety is the number one priority in a clinical trial. Therefore, it’s important that you take all your medication as prescribed and to follow your scheduled visits.  It is vital that you answer any research staff’s questions regarding how you feel and whether you’ve had any changes to your current prescribed medications.

Many study volunteers appreciate the additional medical attention that they receive when they participate. Your study investigator needs to record any health symptoms no matter how minor they may seem to you. If you miss your medication or you haven’t taken it on schedule, tell your physician or research staff. Your input is valuable and important to the success of the study’s results.

When you participate in a clinical trial, your privacy is protected. Your medical records are confidential. The trial data that is provided to the Pharmaceutical Company and Health Canada will not include your name or the names of other individuals participating in the study.

As a volunteer, you have the right to leave your study at any time, and for any reason.

What happens after the trial?

After a study phase is complete, the data is collected to determine the drug’s effectiveness, if it is safe and if there are any side effects.

Depending on the results, researchers then determine whether to stop testing or move to the next phase of the study. After the 3rd phase of research, researchers decide if the results are medically important and may submit them to journals for peer-review or to governmental agencies for drug approval.

If you are interested at this time to determine if you received active drug or placebo you can call the clinical site to follow up on unblinding of study medication.  Occasionally, you may receive compassionate care medication until a drug is approved and available on the market.

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