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Posted On: 01/26/2021 6:51:52 PM
Post# of 154979
Surprisingly, the unblinding of trial data is not a topic talked about much anywhere I researched. Lots on locking trial databases and such on Youtube along with info about cleaning up the data with queries, blah, blah, blah. Many hoops to jump through to get to the final product produced by the CRO and then presented to the Sponsor (CYDY).
The final product is a Trial Master File. It uses cleaned and locked data from the trial. The CRO statistician then probably does most of the work messaging the data into a form that shows the efficacy of the drug. Many people have to sign off on the data and analysis and then the TMF or electronic TMF is archived for long term referral later. Rule, if it isn't documented, it didn't happen.
Amarex will send the TMF to Cytodyn at which time they can look at the data. I have no idea how intelligible the data will be to a non-statistician immediately but that is when we could expect trial results to be unblinded to us. Data will not dribble in from the CRO or anyone else on Primary Endpoints or Secondary Endpoints.
Interestingly, the FDA always deals with unblinded data, meaning I suppose that the sponsors of trials always know how their drug performed before the FDA does. The FDA does get some feedback but that is more on safety. I'm sure they hear some things anecdotally too.
All of this is a much more complicated process than you might imagine because of all the checks and balances to ensure data quality, completeness and accountability.
A sloppy trial would have very nasty consequences - no drug approval, lawsuits, people not getting paid, a waste of time.
The final product is a Trial Master File. It uses cleaned and locked data from the trial. The CRO statistician then probably does most of the work messaging the data into a form that shows the efficacy of the drug. Many people have to sign off on the data and analysis and then the TMF or electronic TMF is archived for long term referral later. Rule, if it isn't documented, it didn't happen.
Amarex will send the TMF to Cytodyn at which time they can look at the data. I have no idea how intelligible the data will be to a non-statistician immediately but that is when we could expect trial results to be unblinded to us. Data will not dribble in from the CRO or anyone else on Primary Endpoints or Secondary Endpoints.
Interestingly, the FDA always deals with unblinded data, meaning I suppose that the sponsors of trials always know how their drug performed before the FDA does. The FDA does get some feedback but that is more on safety. I'm sure they hear some things anecdotally too.
All of this is a much more complicated process than you might imagine because of all the checks and balances to ensure data quality, completeness and accountability.
A sloppy trial would have very nasty consequences - no drug approval, lawsuits, people not getting paid, a waste of time.
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