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Posted On: 07/01/2020 1:51:18 PM
Post# of 148903
Ohm20, You are 100% Accurate (Not that you require my validation...as you know more than most in the world of Biotech)
While in Nursing School between 2016-2018, I worked part time at a Clinical Trial site in AZ (whom performed mostly Phase 2 and 3 trials), practicing my phlebotomy skills. When a trial is Placebo Blinded, meaning zero knowledge of who receives drug vs placebo, ALL SERIOUS ADVERSE EVENTS (SAE's) which include anything from Renal failure, to hepatic injury, and DEATH, are first noticed to the Lead Investigator at the Trial Site, who then reports the SAE to the Trial Sponsor being Cytodyn.
Despite most people's assumptions, SAE's are also not disclosed (so to speak) to the DSMC, or Data Safety Monitoring Committee. The DSMC has predetermined times for unblinding the data during a trial which is coordinated with the Trial Sponsor before initiation of the trial. This is what's called "Interim Analysis" and those predetermined times are either setup at time intervals like 'every 90 days' or setup quantitatively like after 'every 50 patients'. The DSMC unblinding is mostly to look at safety issues, as well as efficacy, within both control arm and placebo arm. But that unblinding or unmasking of data has nothing to do with the Trial Sponsor gaining access to the unblinded data, that is a separate issue which Trial Sponsor typically requests or informs FDA and IRB of their intention to do so at the beginning of trial (so as to not interfere with an ongoing trial).
My opinion only matters to me, my family, and friends, but hopefully I was able to shed a small amount of light in validating what Ohm20 already stated.
While in Nursing School between 2016-2018, I worked part time at a Clinical Trial site in AZ (whom performed mostly Phase 2 and 3 trials), practicing my phlebotomy skills. When a trial is Placebo Blinded, meaning zero knowledge of who receives drug vs placebo, ALL SERIOUS ADVERSE EVENTS (SAE's) which include anything from Renal failure, to hepatic injury, and DEATH, are first noticed to the Lead Investigator at the Trial Site, who then reports the SAE to the Trial Sponsor being Cytodyn.
Despite most people's assumptions, SAE's are also not disclosed (so to speak) to the DSMC, or Data Safety Monitoring Committee. The DSMC has predetermined times for unblinding the data during a trial which is coordinated with the Trial Sponsor before initiation of the trial. This is what's called "Interim Analysis" and those predetermined times are either setup at time intervals like 'every 90 days' or setup quantitatively like after 'every 50 patients'. The DSMC unblinding is mostly to look at safety issues, as well as efficacy, within both control arm and placebo arm. But that unblinding or unmasking of data has nothing to do with the Trial Sponsor gaining access to the unblinded data, that is a separate issue which Trial Sponsor typically requests or informs FDA and IRB of their intention to do so at the beginning of trial (so as to not interfere with an ongoing trial).
My opinion only matters to me, my family, and friends, but hopefully I was able to shed a small amount of light in validating what Ohm20 already stated.
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