Interim analysis? [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2014-06-28 14:09 (3944 d 23:26 ago) – Posting: # 13165
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Hi Naveen,

❝ […] with out two stage in full replicate design, can i have a chance for interim analysis (EMEA).


Would you please so kind and describe in simple words the purpose and performance of the interim analysis you have in mind? What decisions will you make? What measures will you take to maintain the patient’s risk?

<nitpicking>

EMEA mutated into EMA back in 2005.

</nitpicking>

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