munsoned
☆    

US,
2016-05-04 05:53
(2886 d 09:31 ago)

Posting: # 16278
Views: 3,519
 

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

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!
d_labes
★★★

Berlin, Germany,
2016-05-04 11:27
(2886 d 03:56 ago)

@ munsoned
Posting: # 16280
Views: 2,821
 

 Dropouts and Missing Values in RSABE

Dear munsoned,

❝ My question has two parts.


Where is part two?

Answer to part one:
If you study the SAS code given in the FDA progesterone guidance for the evaluation of the 2x2x4 full replicate design you will discover that for the analysis of T versus R subjects must have all four periods to be included.
For the analysis of the intra-subject variability of the Reference subjects must have results for both periods in which the reference was applied.
For the "nice to have" analysis of the intra-subject variability of Test the analogous applies.

Thus it may happen that the different analyses may have different degrees of freedom. If this is reasonable is up to you.

See also this thread and this also.

Regards,

Detlew
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