Dose escalation and DMC [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-01-07 12:18 (421 d 07:06 ago) – Posting: # 21064
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Hi Pharma_88,

I agree with what Ohlbe wrote.

Note that the decision on whether or not to proceed to the next cohort must not be done at the clincal site but by an external Data Monitoring Committee (DMC). See also the EMA’s Guideline.

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Helmut Schütz
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