The Data Safety Monitoring Committee has been or
Post# of 153779
(Total Views: 692)
Posted On: 07/31/2020 10:15:48 AM
Quote:
The Data Safety Monitoring Committee has been organized as of today and the meeting has been set. The meeting will be on Monday, August 3rd, with results due by next week — some time during the next week. -NP
I'm curious if this is a reasonable timeline, given how long it is taking to review the m/m results.
So, the DSMC is going to assemble on Monday to un-blind the s/c data, review the data, deliberate and produce a recommendation (presumably justified by some document with results that may or may not be released to the public)?
Are the primary s/c endpoints just easier to compute and analyze or am I missing something else?
I'm not all that familiar with the DSMC process but the announced timeline strikes me as optimistic based on the apparent effort needed to handle the m/m data.
(2)
(0)