Analysis Sets and Handling of Dropouts and Missing Values [RSABE / ABEL]

posted by munsoned – US, 2016-05-04 05:53 (3210 d 14:04 ago) – Posting: # 16278
Views: 4,194

Hi,

We are currently in the planning stages of a BE trial for a HVD. The current proposed study design is a 2x2x4. We are planning on performing a RSABE analysis.

My question has two parts. First, how are analysis sets defined for a RSABE analysis? Must subjects complete all 4 periods in order to be included in the analysis population? How are dropouts and missing values handled.

For example, what if a subject drops from the study after completing periods 1 & 2. Or, what if a subject vomits during one of the periods?

Any guidance or suggestions is greatly appreciated.

Thanks!

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