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Posted On: 11/05/2020 10:40:45 PM
Post# of 148905
I found this tidbit from the FDAs "Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees"
https://www.fda.gov/media/75398/download
4.4. Potential DMC Responsibilities
4.4.1.4. Consideration of External Data
"Sponsors who wish to have the ability to request interim protocol changes without raising concerns about biasing the study should establish procedures to minimize bias, such as ensuring that they are completely unaware of unblinded comparative data. In such circumstances it may be very advantageous for the sponsor to set up a "firewall" to ensure that those who would be proposing interim protocol changes based on external data are insulated from knowledge of interim comparative results. To avoid any influence of interim data on consideration of protocol changes, FDA staff will also generally remain blinded to the interim results."
Based on the above guidance, it seems like it was CytoDyn who hired the firewall statistician to communicate with the FDA? Maybe that's what Nader meant by "FDA firewall statistician". Since the DSMC did recommend an interim protocol change (42-day analysis), did CytoDyn have to communicate that to the FDA using this firewall statistician to keep things unbiased?
The other part I don't understand is where Nader says the FDA's firewall statistician has received our unblinded data. That statement doesn't correlate with the above.
https://www.fda.gov/media/75398/download
4.4. Potential DMC Responsibilities
4.4.1.4. Consideration of External Data
"Sponsors who wish to have the ability to request interim protocol changes without raising concerns about biasing the study should establish procedures to minimize bias, such as ensuring that they are completely unaware of unblinded comparative data. In such circumstances it may be very advantageous for the sponsor to set up a "firewall" to ensure that those who would be proposing interim protocol changes based on external data are insulated from knowledge of interim comparative results. To avoid any influence of interim data on consideration of protocol changes, FDA staff will also generally remain blinded to the interim results."
Based on the above guidance, it seems like it was CytoDyn who hired the firewall statistician to communicate with the FDA? Maybe that's what Nader meant by "FDA firewall statistician". Since the DSMC did recommend an interim protocol change (42-day analysis), did CytoDyn have to communicate that to the FDA using this firewall statistician to keep things unbiased?
The other part I don't understand is where Nader says the FDA's firewall statistician has received our unblinded data. That statement doesn't correlate with the above.
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