ICH E9 STATISTICAL PRINCIPLES FOR CLINICAL TRIALS

Title:
ICH E9 STATISTICAL PRINCIPLES FOR CLINICAL TRIALS

https://www.gmp-compliance.org/files/guidemgr/E9_Guideline.pdf

Origin/Publisher:

ICH

Content:
This biostatistical Guideline describes essential considerations on the design and analysis of clinical trials, especially the "confirmatory" (hypothesis-testing) trials that are the basis for demonstrating effectiveness.

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