Children’s bodies are different from adult bodies. They need medicines and treatments that are tailored for them. Our goal is to improve medical care for children by helping design, implement and interpret clinical studies safely and accurately.
The National Jewish Health Department of Pediatrics actively participates in both National Institutes of Health (NIH) and industry-sponsored clinical research. Our program studies medications intended for treating children with asthma, atopic dermatitis and food allergies, rhinitis, sinusitis and other medical disorders.
The doctors, nurses and research coordinators from our pediatric clinic participate in our research program. Their expertise helps with study design, procedures, patient education, and data analysis and presentation.
Who makes sure my child will be safe during a clinical trial?
What safety measures are in place to protect my child during a clinical research study?
As a parent, what can I do to feel comfortable with my child participating in a clincial trial?
What are my rights during clinical research?
What questions may I ask during a clinical trial?
Many people work to make sure a trial is safe, even before families are invited to join.
- Scientists identify the right treatment.
- Statisticians help to design the size of the study and what’s needed to get accurate results.
- Investigators are a medical team of nurses, doctors, pharmacists, psychologists and technicians who make sure that the study is done correctly and with the right participants.
- Institutional Review Boards (IRBs) are independent committees that review the trials before, during and after the study ends. They make sure that parents and children are informed and protected in the studies.
- There are many government rules that protect children in clinical research.
- Each study has its own research team that handles operations and safety.
- Some studies have other impartial boards to oversee data and safety. These boards can decide if a study should be changed or closed at any time for safety issues.
- Some studies have a medical monitor (a doctor or nurse who is not part of the study) to review side effects that may happen during the study.
Understand the possible risks and benefits of the trial and how they apply to your child.
- Review the safety measures in place.
- Get to know the study team.
- Understand your rights.
- Ask questions: we welcome all questions!
- To not be pressured into joining a research study.
- To be told all the known or possible risks and benefits of the treatments in the study.
- To receive complete information about the study: how it will be done, what you need to do and what it means for your child.
- To ask questions about the study before, during and after the study.
- To know any costs to you or your insurance company.
- To know about other treatment options, if any exist, and their risks and benefits.
- To know how your personal information will be shared and protected.
- To receive a copy of the signed and dated written informed consent form when a form is used.
- To learn about any new information that the researchers may discover about the treatments during the study.
- To leave a research study whenever you want.
You can ask any question! Here are some common questions we receive:
- Why is the trial being done?
- Who is paying for and supporting the study?
- How will you protect my child’s safety?
- What types of procedures, tests and treatments will my child have?
- What happens if my child has any pain?
- Do I still take my child to his/her primary doctor?
- Should my child take any other medicine during the trial?
- How many visits does it require and how long does it last?
- How will the study affect other family members?
- Do I have to pay for anything?
- Who can I talk with if I have a question during the study?
- What are my responsibilities?
- What are the possible benefits?
- What are the risks?
- Are there other options available?
- What do I do if I need help during the trial?