Log in
RegisterPowerTOST and Sample size estimation for R-SABE [RSABE / ABEL]
Hi all,
I have estimated one sample size for partial reference replicated study below.
By considering 12 dropout total sample size will be 54+12=66. I have used CV from our earlier in-house study (calculated from Swr).
Now CRO has given me the same sample size but with different justification. They kept power 90%, CV=0.34 (from literature). Sample size=49+17=66.
In our earlier study we had 9 dropouts out of 66. According to them they cannot use my justification because we will be in trouble if number of dropouts will get exceeds from 12 and in that case we will have subjects <54 (calculated by me). Then what is correct here ? I am confused.
I have estimated one sample size for partial reference replicated study below.
By considering 12 dropout total sample size will be 54+12=66. I have used CV from our earlier in-house study (calculated from Swr).
+++++++++++ Equivalence test - TOST +++++++++++
Sample size estimation
-----------------------------------------------
Study design: partial replicate (2x3x3)
log-transformed data (multiplicative model)
alpha = 0.05, target power = 0.8
BE margins = 0.8 ... 1.25
Null (true) ratio = 0.95, CV = 0.42
Sample size (total)
n power
54 0.807190
Now CRO has given me the same sample size but with different justification. They kept power 90%, CV=0.34 (from literature). Sample size=49+17=66.
In our earlier study we had 9 dropouts out of 66. According to them they cannot use my justification because we will be in trouble if number of dropouts will get exceeds from 12 and in that case we will have subjects <54 (calculated by me). Then what is correct here ? I am confused.
—
Kumar Naidu
Kumar Naidu
Complete thread:
- Sample size calculation for R-SABE Lucas 2014-02-07 11:41 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA’s ABEL Helmut 2014-02-07 14:21
- EMA’s ABEL Lucas 2014-02-07 16:49
- Carry-over Helmut 2014-02-07 17:12
- Carry-over Lucas 2014-02-07 17:42
- Carry-over Shuanghe 2014-02-10 17:11
- Carry-over Lucas 2014-02-07 17:42
- Carry-over Helmut 2014-02-07 17:12
- EMA’s ABEL Lucas 2014-02-07 16:49
- PowerTOST and Sample size estimation for R-SABE d_labes 2014-02-07 14:37
- PowerTOST and Sample size estimation for R-SABEkumarnaidu 2014-04-18 13:38
- PowerTOST and Sample size estimation for R-SABE Dr_Dan 2014-04-18 19:29
- PowerTOST and Sample size estimation for R-SABE kumarnaidu 2014-04-19 06:04
- PowerTOST and Sample size estimation for R-SABE Dr_Dan 2014-04-18 19:29
- PowerTOST and Sample size estimation for R-SABE Astea 2015-06-25 01:14
- Sample size for scABEL/RSABE vs. conventional ABE d_labes 2015-06-25 09:19
- PowerTOST and Sample size estimation for R-SABE mittyri 2015-06-25 10:43
- PowerTOST and Sample size estimation for R-SABE Astea 2015-06-25 13:54
- Scaled ABE d_labes 2015-06-25 14:04
- PowerTOST and Sample size estimation for R-SABE Astea 2015-06-25 13:54
- PowerTOST and Sample size estimation for R-SABEkumarnaidu 2014-04-18 13:38
- EMA’s ABEL Helmut 2014-02-07 14:21
Ing. Helmut Schütz