URGENT opportunity to help GBM patients
OurBrainBank hopes everyone in our community is safe.
Here's one useful thing you can do today to help GBM patients: please comment on the FDA’s proposal to improve the clinical trial process.
– Full text of proposed changes: Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
– Effective comment tips.
Craft your own or feel free to use this:
[begin sample comment]
I support this effort, GBM patients need new treatments now. I endorse 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.
[end sample comment]
Deadline is March 19, 5pm ET
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.
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.
Read public comments
OurBrainBank’s official comment
Thank you and stay safe!
The OurBrainBank Team: Jessica, Aurelia, and Martha