Here is what we need the FDA to understand:
"External Real World Evidence from patient data already exists! This MUST be used as the “control arm” in clinical trials.... INSTEAD of sacrificing any more people from this patient population to placebos in lieu of actual treatment!"
"These Patients are going to die quickly, therefore, it makes no sense to give them a placebo in a clinical trial instead of the treatment, especially when the external patient data already exists and can be used as the control arm w/in the clinical trial design/protocol for rare diseases." ~Dellann Elliott Mydland, President & Chair, The EndBrainCancer Initiative
~~ Don't Miss This Deadline ~~
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either ONLINE or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-2983
