Clinical Research For Pediatrics
Expanding new or existing treatments for Pediatric conditions cannot be achieved without clinical trial volunteers We understand that participating in a clinical trial is a deeply personal decision and choosing the best care option for your child can feel overwhelming. It’s important to take time to gather information and discuss your treatment and investigational options with your child’s doctor, your family, or others in your support system.
For Parents & Guardians
Why consider a clinical trial for your child?
Clinical trials are research studies that are designed to learn more about how to prevent, detect, and treat various diseases. They potentially can also help people with long-term illnesses improve their day-to-day experience living with their illness. Without research, doctors are unable to know the best ways to diagnose and treat children of all ages. Before deciding if a clinical trial is a good option for your child, it’s important to learn more about the study, including its risks and benefits.
What to Expect - Before the Trial
What to Expect - Before the Trial
When it comes to your child’s participation in a clinical trial, we’re here to help you understand each step of the process. From meeting with the team responsible for the research study to joining a community of other trial participants and their families, here are a few things you can expect along the way.
Learn more about the potential risks and benefits to make the most informed decision for your family. Understanding Clinical Trials printable version
Before deciding if your child should participate in a trial, you’ll spend time with the team to review possible risks and benefits and ask any questions you may have about the study. This process is called Informed Consent:
- Informed Consent is designed to ensure participants have all the information they need to make an informed decision about trial participation.
- If you choose to have your child participate, you’ll provide written permission for additional screenings and access to your child’s health records.
- In addition to permission from parents, many clinical trials also require assent from children. Assent means that children are asked – and agree – to participate.
- To provide assent, children must be old enough to ask questions and understand basic facts about the clinical trial.
Another important consideration before your child begins a clinical trial is the potential impact it may have on your family’s existing lifestyle. Consider that your child being a trial participant may require the following:
- Making more trips to the doctor's office or hospital (possibly overnight).
- Seeing new doctors or specialists at different locations.
- Following more involved or complex treatment requirements.
Keep these things in mind when deciding if a trial is a good idea for your child.
What to Expect - During the Trial
What to Expect - During the Trial
The ethical and legal codes that govern medical practice may also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to help protect the participants.
Understanding Clinical Trials printable version
- Your child’s rights, welfare, and privacy are a priority. We follow the strict regulatory and ethical guidelines of the FDA and Ethics Review Boards.
- You’ll be in the know. We’ll inform you and your child of the known risks and benefits before your trial starts (also known as Informed Consent or Assent if child has the necessary capacity).
- You can always ask. Ask as many questions as you want—we’ll always answer.
- Your child can stop participating at any time. Your child can withdraw from a trial at any time, for any reason.
- Your child is not alone. They’ll join a community of other clinical trial participants.
- Your child will make a difference. Your child’s participation contributes to science and may help us develop new treatments that make lives better and contribute to science.
Important Questions
Important Questions
Asking questions and communicating with the Principal Investigator and Study Coordinator will help you feel confident in your decision. Here are some questions you might want to ask (Clinical Trial Questions Printable Version):
- What is the purpose of the trial?
- Why is my child a good candidate for this trial?
- How does this investigational treatment differ from what my child is currently receiving?
- What are the benefits, if any, to my child?
- What are the risks/potential side effects (both short-term and long-term)?
- Why do the researchers believe that the treatment being studied may be better than the one being used now? Why may it not be better? What are the chances my child could receive placebo?
- What tests, medicines, or therapies will be administered?
- How will we know if the investigational treatment is working?
- How and when will we be told about the trial's results?
- Will my child need to be hospitalized or see doctors at other locations?
- How long will the trial last?
- Will I have to pay for any of the treatments or tests?
- What costs will my health insurance cover?
- Who pays the medical bills if my child is injured in the trial?
- Who can help answer questions from my insurance company?
- Are any personal costs such as meals, compensation for time away from work, or gas paid for by the organization or individual running the clinical trial?
- Who will provide information and support to my child and me during the trial?
- Can I speak to someone else not involved in the trial?
- What happens after the trial has ended? Will my child continue on the investigational treatment if it's working well?
- Will follow-up care be offered after the trial is over?
For Kids
Pediatric Resources
Informed Consent
Imagine for a moment you are a patient considering clinical trial participation. Or perhaps you have a family member or friends that are considering clinical trial participation. Either way, let's say you want to understand more about clinical trials and whether or not you (or your loved one) should participate. This blog explores the informed consent process in clinical trials.
Search Our Trials
In order to learn more about pediatric research opportunities, please click the button below for a listing of ongoing clinical trials sponsored by Lilly.
