At the Center for Pediatric Excellence, we participate in clinical research on medications and/or alternative treatments for children and teens. Current research includes children and teens who have ADHD and/or Autism (ASD), or Migraines. Before new medications, treatments, therapies, or medical devices are available to doctors and patients, clinical research is done to test their safety and effectiveness. Clinical research can also help doctors and researchers learn more about how to prevent, detect, or treat illness and disease. Additional clinical research is done after medications are approved by Health Canada. For more information about the impact of clinical research you could watch this video titled “The Impact Clinical Trials Have on All of Us”
A note from Dr. van Stralen on clinical research
I have been interested and involved in research since elementary school. Today I am really proud to lead a talented research team at the Center for Pediatric Excellence. We are able to offer patients the opportunity to participate in local, national and international clinical trials. In medicine, research is not just interesting but essential. Without inquiring minds, medicine would be at a standstill. Asking questions and testing hypotheses is how we make advancements for patients. I have also realized that by participating in research, I am able to stay on top of new advancements, enhance my own critical thinking and offer these benefits to all my patients whether they enrol in a clinical trial or not.
I got involved in clinical research because of its potential to help patients. The status quo isn’t good enough for me. If there is a possibility of advancement for patients, I want to be part of the discovery. When we ask questions and push boundaries only then can our knowledge grow. In medical research, this growth in knowledge helps my patients.
Clinical research is categorized by Phases. Each phase has a particular purpose. Every medication you take regularly has gone through Phases 1, 2, and 3, and may have current Phase 4 Research. At the Center for Pediatric Excellence, we do Phase 2, 3, and 4 clinical trials.
While an entire clinical trial may take years to complete, each patient is typically only involved in a trial for a few months to a year.
Health Canada gives permission to pharmaceutical companies to do clinical research and decide whether to allow all doctors and patients to have use of a new medication. In the United States of America it is the FDA, or Food and Drug Administration that does this. Each country has its own agency responsible for this job.
When an agency allows all doctors and patients to have use of a new medication or other type of therapy or device, it’s called granting approval. In Canada, the term Health Canada-approved means that a medication or other type of therapy or device has passed Phase 3 Research and is available to doctors and patients in Canada.
The idea of putting your child on medication in a clinical trial may seem scary. That’s perfectly normal. For most of us, the only news we hear about clinical research is when there are bad outcomes. Or you may be picturing a science lab where doctors run experiments on animals and/or people. The truth is that clinical research is very closely monitored by governmental agencies and ethics boards (institutional review board – IRB) to protect patients. If your child is a clinical trial patient at the Center for Pediatric Excellence, they will be closely followed by our medical team and monitored for negative and positive effects from the treatment. Check out the frequently asked questions below.
Frequently Asked Questions
Clinical Research at the Center for Pediatric Excellence provide an opportunity for children and teens with ADHD and/or Autism (ASD), or Migraines to access new and alternative treatments, consult with and monitoring by Dr. van Stralen and our medical team. Before you and your child agree to participate in a clinical trial, you will likely have a lot of questions. Dr. van Stralen and her research team will be happy to answer any questions you have that are specific to a trial and/or your child. Below are questions that parents often ask us about clinical research and our answers. Visit our Current Clinical Trials page to find out about current research trials at the Center for Pediatric Excellence. Our research staff include: Dr. van Stralen our principal investigator and head of the research team, Katrina Pullia is a Physician Assistant, who conducts many of the clinical assessments, Suzannah Wojcik is our Clinical Research Coordinator, Dr. Brazeau is a clinical staff on some trials and Hannah Gray is our research assistant.
What is a clinical trial?
Clinical research trials are a type of research study that help doctors and researchers learn more about how to prevent, detect, or treat diseases. The goal of a clinical trial is to find out if a treatment is safe and effective and/or to learn more about a disease or condition.
Why do clinical Research with children?
It is important to study new treatments in children because a children and teens have different bodies from full-grown, fully developed adults. This means that their treatment needs are often different than adults. Children’s bodies may metabolize medication differently and they can also have different diseases or diseases that act differently than adults.
Children’s participation in clinical research is important so that doctors and researchers can learn about:
Medications for children so doctors can give them the right medications and strengths/amounts
Diseases that only happen or happen differently in children to learn about new treatment options
Are clinical trials safe?
The main concerns in clinical research are to protect the well-being of patients, minimize risk and maximize benefits. Clinical research is designed and monitored to minimize or, whenever possible, eliminate potential harm to patients and puts safeguards in place to catch any problems before or as soon as possible after they arise. At the Center for Pediatric Excellence, clinical trial participants and their families have direct access to research staff and clinicians to ask questions, voice concerns, and request to be seen prior to a scheduled appointment. All clinical trials with experimental medication must be approved both by Health Canada and an independent ethics board (IRB) prior to enrolling patients.
Why would I sign my child up for a clinical trial? How would they/we benefit? What are the risks?
Clinical research is done for many reasons, including to help us to learn more about new or alternative treatments. Doctors and researchers are always looking for the safest and most effective treatments for patients. Clinical research allows us to see if an alternative or new treatment may work better than the currently available ones. However, as with all new or existing treatments, there may be certain benefits and risks.
Throughout the study, Dr. van Stralen and her team will continually assess the interest of you/your child. An individuals health and well being remains the #1 priority.
- Access to new drugs or treatments that are not yet available otherwise
- Close follow up and monitoring as well as additional study specific assessments that may help guide their care
- Closer monitoring or extra testing that may not be a part of regular care
- Specialized follow-up with Dr. van Stralen and the medical team
- Provide information that could benefit other children in the future
- Treatment may be unpleasant or there may be side effects
- Study treatment may be ineffective or less effective than other available treatments
- The study may involve a lot of time and effort, including extra appointments and more tests than usual
- Your child may need to follow complex medicine dosing or study procedures
My child’s other parent/legal guardian does not want my child in a clinical trial. Can my child still participate?
No. It is our policy that, unless you have sole custody and medical decision-making (with legal documentation of this), both parents need to agree to your child participating in clinical research. In addition to this being the policy at the Center for Pediatric Excellence, in some clinical research the ethics boards require this.
Does my child need to consent?
People under the age of 18 cannot legally consent to participate in clinical Research; however, it is required that they understand and are willing participants. This is called assent. At the Center for Pediatric Excellence, we believe that children have bodily autonomy. That means that they have a say in what happens to their bodies and their medical treatment. At the same time that you are asked for your informed consent, we will explain the clinical trial to your child in a way that they will understand. If they agree to participate, they will sign a separate assent form.
Does my child need to already have a diagnosis in order to participate?
Not necessarily. For many of our clinical trials, before you participate, one of our research staff will ask you questions about the symptoms your child has and/or other reasons you believe they may have the condition. The research staff will consult with a doctor and if they determine that your child may meet criteria for the diagnosis, we will arrange a pre-trial appointment that would include an assessment of the condition at no charge to you. If it is determined that your child does not have the diagnosis required for the clinical trial, then you and your child will not be able to participate in the clinical trial, but the clinician will discuss possible next steps regarding other assessments and/or treatment.
Does it cost money to participate in clinical research?
No. All costs for the clinician’s time, assessments and trial medications will be covered. In many cases you will also receive reimbursement for travel to appointments.
Will I get paid for participating?
No, it is not ethical to pay for participation in clinical trials. However, most of the clinical research at the Center for Pediatric Excellence do provide a stipend to cover out of pocket expenses like travel and parking.
How long and how much time will it take?
The length and time commitment depends on the specific clinical trial. It can last for 2 months to over a year. The frequency, length and type of appointments (in person or virtual) depend on the specific clinical trial.
What if I change my/my child changes their mind partway though?
You can stop participating in a clinical trial at any point for any reason or no reason at all. You will be asked why you no longer want to participate for us to learn what isn’t working for you and/or your child and how we may be able to change things for other participants, but you will not be pressured to remain in the study. You will also be asked to return any clinical trial materials and/or unused medications.
What’s the process for participating in clinical research at the Center for Pediatric Excellence?
2. Pre-screening: One of our research staff will contact you with information about the study you’re interested in and/or other studies that your child may be eligible for. They will also ask you some questions about your child and their health history to determine if your child may meet the criteria for the study. This is usually done via a 15- to 30-minute telephone call, and/or by completing a questionnaire sent by email.
3. Trial Consult: Typically, an approximately 90-minute virtual appointment on an online videoconferencing platform. Our Physician Assistant and/or Dr. van Stralen will conduct a more thorough assessment of your child’s history and symptoms. In preparation for this appointment, one of our research staff may ask you to provide your child’s relevant medical records, past assessments, and/or ask you and your child’s teachers to complete a series of questionnaires.
- If your child meets the eligibility criteria for the study, we will discuss the next steps with you, such as arranging any additional assessments that may be needed (e.g., to confirm a diagnosis), or booking your first in-person study appointment. You can also choose if you would like your child’s family doctor notified of their participation in the specific study.
- If your child is found to be ineligible, or if the study is not in your child’s best interest, you will be provided with additional information on community resources that you and your child may find helpful. With your permission, your child’s family doctor or pediatrician will also be provided information about the assessment.
4. Decision to Participate: Before your first study appointment, you and your child will be given time to review the consent and assent forms. The study-specific details, possible risks, and procedures to expect during your visits will be listed in these forms.
5. First Study appointment: The first study appointment will be in-person with a Physician Assistant and/or Dr. van Stralen. The length of this appointment depends on the study, but it is typically the longest study appointment. Every clinical trial is different, but the following is what you can expect at this appointment:
- Informed consent and assent – Every clinical trial will include this step. Before we do any tests for the trial, one of our research staff will go through the trial procedures and anticipated risks and benefits with you and your child, and answer any questions either of you have. If you still want to participate, you and your child will each sign a form consenting (you) and assenting (your child) to participate.
- Collecting information from you and your child – This is so that we have a full picture of your child’s health and symptoms before we start the clinical trial treatment (AKA your child’s baseline). As you move through the trial, we will be comparing your child to their baseline to see if the treatment is helping and if they are experiencing any side effects. The information needed is different for each trial, and can include any combination of developmental, intelligence, and diagnosis-specific testing, parent and child questionnaires, physical exam, blood tests, ECG, urine test, and/or pregnancy test.
- Receiving clinical trial materials and/or medication – Depending on the trial, the treatment may begin immediately after the initial appointment. If this is the case, you will either be given medication at this appointment, or a prescription will be sent to your pharmacy for you to pick up free of charge (medication is typically covered by the study during clinical trials). You will also be given and provided instructions for any questionnaires or forms you will need to fill out and any other study materials you will need before your next appointment.
6. Other study appointments: You will know what to expect before you and your child give informed consent and assent. The number, frequency, and format (virtual or in-person) of appointments is different for every clinical trial. You or your child can withdraw consent or assent and leave the clinical trial for any reason at any point.
7. End of Clinical Trial: After your study participation is complete, you may be offered continued specialist care at the Center for Pediatric Excellence. You will be re-directed back to your family doctor or pediatrician for your child’s primary care.
What if the treatment doesn’t work for my child?
Every person is unique, so no treatment, whether in a clinical trial or not, will work for everyone. There is the possibility that your child’s clinical trial treatment will not be effective for the specific concerns you and/or your child have. If this happens, discuss your concerns with the medical team. Depending on the trial and where you are on the trial timeline, the clinicians may be able to offer other things to try or adjust the medication dosage. You can also choose to leave the clinical trial and Dr. van Stralen may still continue to see your child for follow-up and work with you and your child to find the most effective treatment to meet your treatment goals. It is helpful fo you discuss your reasons for leaving with the medical team because it is information, we use to determine whether or not this treatment can be used to help other kids.
What if the treatment makes my child worse?
Notify the medical team if you and/or your child have concerns that the clinical trial treatment is making your child’s condition worse. Clinical trial participants are closely monitored. You can contact our research coordinator directly and we can schedule an earlier appointment. If there is an emergency, call 911 and/or go to an Emergency Department. You will also be given a direct number for our on call clinician you can call 24/7 in case of emergency. If the clinical trial treatment is making your child’s condition worse or they are experiencing negative side effects, you can always choose to leave the trial. Depending on the situation, the medical team may also inform you that your child is being removed from the clinical trial. If either of these situations should occur, Dr. van Stralen and her medical team would offer to continue to see your child for follow-up and work with you and your child to find the most effective treatment(s) for you and them.
What are side effects? Are they more common in clinical research?
Side effects are anything that happens to a person in response to a treatment that was not an intended effect of the treatment. For good reason, we typically focus on negative side effects, also called adverse events (things that make us feel uncomfortable, unwell and/or put us at risk for or cause other or more serious conditions). But treatments can also have positive side effects (for example, a medication that is prescribed for depression may also reduce a patient’s headaches). All treatments – even over the counter medications and supplements – have potential side effects. Depending on the clinical trial phase, we may know less about how people typically react to a treatment and its side effects because fewer people have used the treatment.
What happens if my child experiences side effects in a clinical trial at the Center for Pediatric Excellence?
When you and your child are making the decision to participate in a clinical trial at the Center for Pediatric Excellence, a clinician from our medical team will go over all the known side effects of the treatment and their frequencies so you can factor that into your decision. Once in the clinical trial, you will have direct numbers to research staff to ask questions, report any issues you and/or your child is having related to the trial, request to see a clinician, and to speak to a clinician directly 24/7 in the case of emergency. You can always choose to leave a trial at any point due to an adverse event, or any other reason. At each of your appointments, a clinician will ask about any side effects your child is experiencing. It is important to report any side effects as soon as you and/or your child detect them because they tell us something important about the treatment being tested. If your child is experiencing an adverse event (negative side effect), depending on the trial and adverse event, the clinician may recommend a treatment (ex. lotion for dry skin or Tylenol for a headache), an adjustment to the treatment medication, or advise that your child no longer participate in the clinical trial.
What is a placebo?
A placebo is essentially a pretend medicine. Placebos look exactly like the pill, liquid, or powder that the clinical trial is testing, but does not contain the medicine. They are used to see how well the medication treats what it’s supposed to treat (effectiveness) and the side effects of the medication. Depending on the clinical trial, some patients will be given a placebo instead of the medication or patients will go through a period when they’re given the treatment medication and another period when they’re given the placebo. Some, but not all, of our clinical research at the Center for Pediatric Excellence involve a placebo. You and your child will be told before giving informed consent and assent if the clinical trial involves a placebo and how the placebo is being used.