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Re: Plummy Potter post# 13425

Wednesday, 08/14/2019 11:00:58 AM

Wednesday, August 14, 2019 11:00:58 AM

Post# of 21531
This is my understanding anyway that investigators could possibly discern a trend for increased cognition while finalizing the data before final readout. Would be much easier if a drug is showing increasing scores vs normal drug attempts that are just trying to manage the decline. Also keep in mind that there would be something they could compare anything they are seeing at this stage vs what they saw in the original trial just as we've seen with the low drop out number this time. None of this has anything to do with unblinding as to which patients are in which group. My understanding is company officials would be involved in the process before locking the data. JMHO as I'm not in the clinical trial business.

https://www.ncbi.nlm.nih.gov/books/NBK286004/

Under #3. After study completion, investigators and/or sponsors clean the data, derive additional variables, adjudicate endpoints, lock the data set to create the full analyzable data set, carry out prespecified and additional analyses using software programs (the analytic code), and prepare manuscripts for publication.
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