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loanranger

06/09/21 12:06 PM

#362064 RE: Lemoncat #362039

"we took an excerpt from page 9 for you multiple times."

I addressed your excerpt once. This time will make it multiple times:
"FDA strongly discourages disseminating data from ongoing trials. Knowledge of accumulating data by trial investigators and patients can adversely affect patient accrual, adherence, and retention, as well as endpoint assessment, compromising the ability of the trial to reliably achieve its objective in a timely manner."

The only aspect of the current trial that is ongoing is a "So how ya doin'?" phone call. The participant isn't a Doctor or an investigator and they can only offer a lay opinion, assuming they can breath and speak. Only if they can't will the phone call have a statistical value. It's obviously too late to deter or encourage any potential new participants in the trial...recruitment and treatment are done.
At this stage these things are not likely to be affected by an announcement: "patient accrual, adherence, and retention, as well as endpoint assessment, compromising the ability of the trial to reliably achieve its objective in a timely manner".
If you think they would, please say how.