I need a guideline or a reference that contains an explanation of the superiority margin I can use in a clinical trial, or how to decide it. I have found one from FDA for non-inferiority, but none about superiority.
There is a European Guideline on „Points to Consider on Switching between Superiority and Non-inferiority“ see the attached link (and scroll down there)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000366.jsp&mid=WC0b01ac0580032ec4
hope that helps.
kind regards
H
Dear Thais,
You can also refer
1. ICH guideline E10 page no 12
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E10/Step4/E10_Guideline.pdf
2. http://www.fda.gov/downloads/Drugs/.../Guidances/UCM202140.pdf
3. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129505.pdf page no. 49590
4.http://www.ais.up.ac.za/med/tnm800/EssentialTNM800/DayTwo/InterventionResearch/equivalence.pdf
Thnx
Dear Thais, you will find a very complete explanation of this and related topics in the book:
Design and Analysis of Non-Inferiority Trials
Rothmann, Wiens and Chan.
Chapman &Hall. 2012.
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