Pediatric Low-Grade Glioma Externally-Led Patient-Focused Drug Development (pLGG EL-PFDD) Meeting Presented by the Pediatric Brain Tumor Foundation
The pLGG EL-PFDD Meeting, hosted by the Pediatric Brain Tumor Foundation on February 23, 2024, offered a unique opportunity for pediatric low-grade glioma patients, survivors, their families, and caregivers to speak directly to the U.S. Food and Drug Administration (FDA), pharmaceutical companies, and the public about their current and past experiences with pLGG and the impact the disease has had on their daily lives. After the meeting, the Pediatric Brain Tumor Foundation will publish a Voice of the Patient report based on the insights patients, families, and caregivers share.
Submit Your Written Comments About pLGG
If you are a pediatric low-grade glioma patient, survivor, parent, family member or caregiver, we encourage you to use the form below to submit a comment about the following topics. The comment form will remain early until March 23, 2024.
Which pLGG symptoms have the most significant impact on your/your child’s life?
How does pLGG affect you/your child on best and on worst days? Describe your best and worst days.
What specific activities important to you/your child can you/your child not do at all or as fully as you/your child would like because of pLGG?
How have your/your child’s symptoms changed over time? How has your/your child’s ability to cope with the symptoms changed over time?
What do you fear the most as you/your child get older? What worries and frustrates you most about your/your child’s condition?
What are you currently doing to manage your/your child’s pLGG symptoms?
How well do your/your child’s current treatments address the most significant symptoms of your/your child’s pLGG?
What are the most significant downsides to your/your child’s current treatments and how do they affect your/your child’s daily life?
Short of a complete cure, what specific things would you look for in an ideal treatment for pLGG?
The comment period will remain open until March 23, 2024. Comments about different topics should be submitted individually.
What Is an EL-PFDD Meeting?
Externally-led Patient-Focused Drug Development (EL-PFDD) Meetings bring together patients and caregivers, representatives from the U.S. Food and Drug Administration (FDA) and other regulatory/federal agencies, pharmaceutical companies, academic researchers, clinicians, and healthcare professionals who are experts in a particular disease.
The goal of the Pediatric Low-Grade Glioma Externally-Led Patient-Focused Drug Development Meeting is to give pLGG patients and survivors, their families, caregivers, and patient advocates an opportunity to directly share with the FDA and pharmaceutical companies the symptoms that matter most to them, the impact the disease has on their daily lives, and their current or past experiences with available treatments.
This virtual meeting included remarks from the FDA, two brief clinical and treatment overview presentations by pLGG medical experts, patient/caregiver panels, and extensive audience discussion sessions about pLGG symptoms, the disease’s impact, and treatments. View the full agenda here.
Participants’ input will help the FDA and other attendees make future decisions about new drugs, from development to approval.
After the meeting, a report titled "Voice of the Patient" will be produced by the Pediatric Brain Tumor Foundation and sent to the FDA. This will give the FDA a reference point for their decisions concerning the approval of potential pediatric low-grade glioma treatments. The report will also be available to the public, including pharmaceutical companies.
Frequently Asked Questions
If I submit a question or comment or take a patient survey for this meeting, what will you do with the information I provide?
The information you provide will remain strictly confidential and will be used for planning the meeting.
Some of your responses may be included in the meeting, in the Voice of the Patient Report, or in other associated documents. Patient identification will always be removed and patient information will be presented as grouped data from many patients. If you have questions about how your responses will be used, please email [email protected].
When and for how long is the meeting?
The meeting took place on Friday, February 23rd, 2024 from 10 a.m. to 3 p.m. Eastern Time.
The Pediatric Brain Tumor Foundation will produce the Voice of the Patient Report. This will be posted on our website and sent to the FDA and can be used to help in their decisions to review and approve potential treatments for pediatric low-grade glioma.
Is this for adult survivors of a PLGG?
Yes! We welcome patients and survivors of all ages who were diagnosed with a low-grade glioma when they were between the ages of 0 and 18 years old.
Is this for low-grade glioma patients diagnosed as an adult?
No. This meeting will specifically focus on the needs and experiences of families of a low-grade glioma patient or survivor who was diagnosed when they were between the ages of 0 and 18 years old.
The Pediatric Brain Tumor Foundation is the largest patient advocacy funder of pediatric brain tumor research and leads the way in supporting families affected by this disease. Visit curethekids.org/research to learn how we're changing the treatment landscape for children with low-grade gliomas and other brain tumors. If you and your family need help following a child's brain tumor diagnosis, email us today at [email protected].