Nader referred to the statistician as a "firewall
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Posted On: 11/05/2020 7:57:12 PM
Nader referred to the statistician as a "firewall statistician."
There is another FDA mandated entity that is always monitoring trials like our CD12. It is called the Institutional Review Board. It is absolutely informed of all SAEs and AEs and has a lot of power over trials. It is also sometimes called the Institutional Ethics Board. I researched a little about it but here is what the FDA has to say about its purpose -
"Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research."
https://www.fda.gov/about-fda/center-drug-eva...cal-trials
They absolutely can be called a FIREWALL in these trials. Do they have a statistician? They absolutely could ask for Interim Data. They probably are even more empowered under the provisions of eIND trials.
This could be what Nader was referring to.
I do know that IRB reviews are ongoing and not periodic. Thus their ability to halt a trial at any time on the basis of SAEs and AEs.
There is another FDA mandated entity that is always monitoring trials like our CD12. It is called the Institutional Review Board. It is absolutely informed of all SAEs and AEs and has a lot of power over trials. It is also sometimes called the Institutional Ethics Board. I researched a little about it but here is what the FDA has to say about its purpose -
"Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research."
https://www.fda.gov/about-fda/center-drug-eva...cal-trials
They absolutely can be called a FIREWALL in these trials. Do they have a statistician? They absolutely could ask for Interim Data. They probably are even more empowered under the provisions of eIND trials.
This could be what Nader was referring to.
I do know that IRB reviews are ongoing and not periodic. Thus their ability to halt a trial at any time on the basis of SAEs and AEs.
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