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April 26, 2023

Submit Comments on use of Placebos in Clinical Trials

Building reslience

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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either ONLINE or written comments on the draft guidance before the close date.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


Enhancing patient outcomes by expanding FDA-approved treatment modalities and fueling research in the pharma/bio/life sciences, device & diagnostic industries and by closing the existing GAP from initial diagnosis to IMMEDIATE AND EXPANDED ACCESS to specialists, researchers, advanced & innovative treatments, clinical trials and critical care with the ultimate goal of improving patient outcomes through updating and improving WHO & NCCN Guidelines and clinical practices related to Standard of Care for brain cancer patients.

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