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Posted On: 11/06/2020 12:44:57 AM
Post# of 148901
Putting the puzzle pieces together, as I understand them.
Just as the name implies, the institution, where the trials are being conducted, has to set up an IRB or an Institutional Ethics Board that performs its tasks in accordance with FDA guidelines. Its mission is to protect those who participate in the trials. It does not concern itself with efficacy of the trial drug. It is not part of the FDA, only answerable to the FDA. It has a wide range of powers, consistent with its duties, over any trial.
The IRB monitors the progress of a trial more or less tightly depending on the perceived risks to patients involved. In some trials you would expect to have many SAEs and AEs and in others not. The IRB monitors some things in a rather constant fashion and, at other times, a periodic fashion.
It is the sponsor who determines if there are interim reviews during a drug trial done by DSMCs. This is done more to look at the efficacy of the drug in trial and make possible adjustments to the trial. Safety is, of course, also looked at but safety obviously can not be left wholly in the hand of a drug's sponsor. Still, a sponsor could end their own trial for safety reasons.
DSMC data is owned by the sponsor but blinded data is of little use if it isn't unblinded to someone.
DSMC recommendations are different from the data and are more or less public. The data can be unblinded by the sponsor to anyone but doing so can destroy the trial. Therefore, sponsors unblind their data sparingly. They often times solicit certain people to look at the data if it would eventually help approval of the drug.
Cytodyn can ask the FDA to look at a trial's interim data if they are asking for an EUA. On what other basis would you ask the FDA for an EUA? Of course you would unblind the data to the FDA or any other regulatory body that asks for it, like OWS who might approve Leronlimab as a favored therapeutic for Covid-19 and worth of financial and manufacturing help.
So both the DSMCs and IRBs follow trials in a sort of parallel fashion but do different things and are answerable to different masters. Statisticians are more needed to determine efficacy in a trial I would think but there may be statisticians in the IRBs as well if, at the end of a trial, the FDA wants a report on safety that meets their standards. Otherwise, the FDA would have to judge safety by the sponsor's data as interpreted by sponsor's DSMC.
If the IRB is to act like a "firewall" to protect patient safety and the IRB is who the FDA turns to for a safety evaluation of a drug in trial, their statistician must be the "firewall statistician." And if the "firewall statistician" ask for the company's trial blinded data, you give it to them! I think that is what Cytodyn did. They have standing to receive the data without threatening the trial.
That's how I put together the puzzle. It would have been easier to put together if Pourhassen hadn't used the obvious shorthand of "firewall statistician"!
(Kabonk, does this make sense?)
Just as the name implies, the institution, where the trials are being conducted, has to set up an IRB or an Institutional Ethics Board that performs its tasks in accordance with FDA guidelines. Its mission is to protect those who participate in the trials. It does not concern itself with efficacy of the trial drug. It is not part of the FDA, only answerable to the FDA. It has a wide range of powers, consistent with its duties, over any trial.
The IRB monitors the progress of a trial more or less tightly depending on the perceived risks to patients involved. In some trials you would expect to have many SAEs and AEs and in others not. The IRB monitors some things in a rather constant fashion and, at other times, a periodic fashion.
It is the sponsor who determines if there are interim reviews during a drug trial done by DSMCs. This is done more to look at the efficacy of the drug in trial and make possible adjustments to the trial. Safety is, of course, also looked at but safety obviously can not be left wholly in the hand of a drug's sponsor. Still, a sponsor could end their own trial for safety reasons.
DSMC data is owned by the sponsor but blinded data is of little use if it isn't unblinded to someone.
DSMC recommendations are different from the data and are more or less public. The data can be unblinded by the sponsor to anyone but doing so can destroy the trial. Therefore, sponsors unblind their data sparingly. They often times solicit certain people to look at the data if it would eventually help approval of the drug.
Cytodyn can ask the FDA to look at a trial's interim data if they are asking for an EUA. On what other basis would you ask the FDA for an EUA? Of course you would unblind the data to the FDA or any other regulatory body that asks for it, like OWS who might approve Leronlimab as a favored therapeutic for Covid-19 and worth of financial and manufacturing help.
So both the DSMCs and IRBs follow trials in a sort of parallel fashion but do different things and are answerable to different masters. Statisticians are more needed to determine efficacy in a trial I would think but there may be statisticians in the IRBs as well if, at the end of a trial, the FDA wants a report on safety that meets their standards. Otherwise, the FDA would have to judge safety by the sponsor's data as interpreted by sponsor's DSMC.
If the IRB is to act like a "firewall" to protect patient safety and the IRB is who the FDA turns to for a safety evaluation of a drug in trial, their statistician must be the "firewall statistician." And if the "firewall statistician" ask for the company's trial blinded data, you give it to them! I think that is what Cytodyn did. They have standing to receive the data without threatening the trial.
That's how I put together the puzzle. It would have been easier to put together if Pourhassen hadn't used the obvious shorthand of "firewall statistician"!
(Kabonk, does this make sense?)
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