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nidan7500

05/15/19 12:14 PM

#192862 RE: Biostockclub #192858

[quoteNow, which method-protocol presents the most trial data and consequently provides the most robust data set for lower risk decisions? Continuous real time AI monitoring or periodic manually assessed data?][/quote]
GAWDD Bios, you sure know how to construct a context. Thank you AWESOME stuff.

I did neglect to construct a decent context for my questions/thought.

Lets say you are working in the Precision Medicine trial protocol context. Lets say you have established the best Biomarker information possible and have pre-selected patients based on knowledge from previous trials(A2-73 5 years, etc.). Armed w/the best Biomarkers you have selected patients and have constructed the protocol to maximize the use of AI and monitoring devices-ERP's. You get the idea, like shooting fish in a barrel.

Your task is to answer the question: Can I reduce the amount of trial time required to establish high confidence in A2-73 efficacy by using known EEG/ERP AI and other monitors while AI assessing Cognitive scores real time remotely? And, is this method likely to be lower risk than conventional methods now in use? We do not want to use the next 2-3 years to assess efficacy, we want to know ASAP but we do not want to make a foolish leap w/associated risks. The key of course is the PM
Protocols narrow pool to 70-80% of total candidates and we get a massive amount of data in a short time period.

My theory is that when you do not know exactly what you are looking for (like the old days) then very long trials are needed to assess and prove efficacy. However, if you know exactly what you are looking for and can continuously VERIFY the results then much shorter times are needed to demonstrate the same level of confidence. You might have 200 patients on line cranking out cognition status data. Hence, PM will allow much shorter trails b/c they are being done for verification of expected results vs using excessive time to resolve doubt. It's a process thing. If we all have to wait 5 years to prove anything, we will NEVER GET THERE.