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RegisterSample size justification [Power / Sample Size]
Hii,
for one study (two way crossover) based on sufficient CV, power and ratio we written protocol as 52 participants are sufficient to establish the bioequivalence however based on dropout/withdrawal rate (10%) we conducted study in 62 participants. But at end only 48 participants completed the study. but as per protocol 52 need to establish BE. study outcome is with in 90% CI. How can we justify for 48 participants. Please help me
Edit: Category changed; see also this post #1. [Helmut]
for one study (two way crossover) based on sufficient CV, power and ratio we written protocol as 52 participants are sufficient to establish the bioequivalence however based on dropout/withdrawal rate (10%) we conducted study in 62 participants. But at end only 48 participants completed the study. but as per protocol 52 need to establish BE. study outcome is with in 90% CI. How can we justify for 48 participants. Please help me
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- Sample size justificationrajasekhar 2017-01-20 09:54
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Post hoc sample size “justification” Helmut 2017-01-20 11:59
Ing. Helmut Schütz