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Monday, February 20, 2017 12:16:56 PM
It's not about "how many", but more of "how much": objective measurements.
Meeting the primary endpoint is the goal, although meeting secondary endpoints is important and can help in designing the next trial. All of the goals are pre-specified.
They submit each patient to baseline tests (SIB, ADL, NPI, MMSE) at time of entering the trial, give the drug (20 or 40 micrograms or placebo) for 12 weeks, give the above objective tests to patients again, run statistics on the numbers, and out comes a p-value and HR and other numbers for each of the doses, that says whether your trial succeeded or failed to meet endpoints, and which dose is more effective.
The threshold for a successful trial is a p-value of .05. The lower the p value, the more confidence in the results.
Nobody here cares about the 2-73 (AVXL) trial, an open-label trial which is subject to patient and investigator biases.
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