– Full text: Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
– Effective comment tips
You could write a simple statement like “I support this effort, GBM patients need new treatments now” or a more in-depth one quoting from the document. Read comments here,
Let’s all do one today! Deadline is March 19, 5pm ET. Takes a day or so for new ones to be reviewed and posted.
Share please — ask all your friends and family who are (we hope) safe and home today to do this one good thing. It might save a loved one’s life.
OurBrainBank applauds the FDA for recognizing the critical importance of clinical trial access for rare disease communities. Glioblastoma patients need immediate access to all emerging treatment options, including clinical trials. This could save lives.
We strongly support the following wording found in section V. A. (lines 543 to 550)
When the disease is life-threatening or severely debilitating with an unmet medical need
As defined in 21 CFR 312, subpart E (21 CFR 312.81), the term ‘life-threatening’ means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes, where the endpoint of clinical trial analysis is survival; the term “severely debilitating” means diseases or conditions that cause major irreversible morbidity. An unmet medical need is a condition whose treatment or diagnosis is not addressed adequately by available therapy.
In 2019, OurBrainBank conducted a survey for the first national GBM Awareness Day, examining the current standard of care. We received 400+ responses in less than a week. There is an urgent need for change in treatment and trial protocols. 95% of patients want to enroll in clinical trials, only 10% actually do. Low trial enrollment means patients don’t have access to new therapies, and researchers can’t complete their studies.
OurBrainBank is an innovative, patient-led movement designed to move glioblastoma from terminal to treatable, powered by patients. It’s the first non-profit created by, with, and for people living with GBM, an aggressive and rare brain cancer.
Founder Jessica Morris was diagnosed with GBM in January 2016. OurBrainBank is a charitable organization based in the US (501c3) and UK. Our study is certified by the New England Independent Review Board and ethics-approved in the UK.