I don't think that's right, but I'm new to this wh
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Posted On: 05/26/2020 2:05:50 PM
I don't think that's right, but I'm new to this whole trials and medical research thing and could easily be wrong. I was basing my comment on the FDA rules for eligibility [paraphased for brevity]:
1) a serious condition in a formal declared "emergency"
2) reasonable to believe the product is effective
3) potential benefit outweighs the risks of side effects
4) no adequate alternative
https://www.fdanews.com/ext/resources/files/a...zation.pdf page 4.
And on a medical researcher's expressed concern with the burden that EUAs can put on clinical trials and enrollment:
"[Dr. Meyerhoff] is concerned that with the advent of the Food and Drug Administration's Emergency Use Authorization (EUA) process, drugs that might have been given to research participants as part of a clinical trial are instead being distributed under EUAs with less oversight and insufficient data collection afterward....[She] says the use of EUAs... bleeds away potential patients from clinical trials that could give officials better information about the drugs." https://www.reliasmedia.com/articles/19074-eu...-emergency
1) a serious condition in a formal declared "emergency"
2) reasonable to believe the product is effective
3) potential benefit outweighs the risks of side effects
4) no adequate alternative
https://www.fdanews.com/ext/resources/files/a...zation.pdf page 4.
And on a medical researcher's expressed concern with the burden that EUAs can put on clinical trials and enrollment:
"[Dr. Meyerhoff] is concerned that with the advent of the Food and Drug Administration's Emergency Use Authorization (EUA) process, drugs that might have been given to research participants as part of a clinical trial are instead being distributed under EUAs with less oversight and insufficient data collection afterward....[She] says the use of EUAs... bleeds away potential patients from clinical trials that could give officials better information about the drugs." https://www.reliasmedia.com/articles/19074-eu...-emergency
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