Deep shit [RSABE / ABEL]
Dear Helmut
» Duno what you mean. Are you considering the sample size of a 2×2×2 crossover? The sample size of the 2-period 4-sequence full replicate is ~½ though the number of treatments / biosamples (driving the study cost) are essentially the same.
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» Try the functions
» The plots in the slide are all for ABEL. A comparison of ABE and the EMA’s (unadjusted) ABEL:
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»![[image]](img/uploaded/image651.png)
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» At 30% sample sizes are 40 and 34, at 40% 68 and 30.
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» Hhm, not sure what you mean.
I just would like to say that it has no sense to conduct ABEL/RABE trials if the CV is assumed around 30% because, in order to control TIE, we have to increase the sample size to around that of usual ABE trials. It violates GCP principles in this case and invalidates the ABEL/RABE approach (subjects are subjected to unnecessary risks in the ABEL/RABE trials). And it very complicates the matter. Basically, when should we consider an ABEL/RABE trial?
Best regards
It also seems that when we wish to control TIE the sample size will be around 50 (worst scenario + dropout rate) in almost every case (usually little known about reference withindividual variability) of the ABEL/RABE. But I have rarely seen such trials.
Regards
Edit: Merged with a later (now deleted) post. You can edit your posts for 24 hours. [Helmut]
» Duno what you mean. Are you considering the sample size of a 2×2×2 crossover? The sample size of the 2-period 4-sequence full replicate is ~½ though the number of treatments / biosamples (driving the study cost) are essentially the same.
»
CV (%) ABE.2x2x2 ABE.2x2x4 n.ABEL n.ABEL.Bonf n.ABEL.adj n.Molins
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20 20 10 18 24 18 22
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30 40 20 34 44 42 42
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40 66 34 30 38 32 36
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50 98 50 28 34 28 32
» Try the functions
pa.ABE()
and pa.scABE()
of PowerTOST
.» The plots in the slide are all for ABEL. A comparison of ABE and the EMA’s (unadjusted) ABEL:
»
»
![[image]](img/uploaded/image651.png)
»
» At 30% sample sizes are 40 and 34, at 40% 68 and 30.
»
» Hhm, not sure what you mean.
I just would like to say that it has no sense to conduct ABEL/RABE trials if the CV is assumed around 30% because, in order to control TIE, we have to increase the sample size to around that of usual ABE trials. It violates GCP principles in this case and invalidates the ABEL/RABE approach (subjects are subjected to unnecessary risks in the ABEL/RABE trials). And it very complicates the matter. Basically, when should we consider an ABEL/RABE trial?
Best regards
It also seems that when we wish to control TIE the sample size will be around 50 (worst scenario + dropout rate) in almost every case (usually little known about reference withindividual variability) of the ABEL/RABE. But I have rarely seen such trials.
Regards
Edit: Merged with a later (now deleted) post. You can edit your posts for 24 hours. [Helmut]
Complete thread:
- Statistical evaluation and BE hypotheses in full replicate design Elena777 2020-01-28 07:02 [RSABE / ABEL]
- Inflation of the TIE as well Helmut 2020-01-29 15:38
- Inflation of the TIE as well Elena777 2020-01-29 20:01
- Tricky… Helmut 2020-01-30 12:07
- Tricky… Mikalai 2020-01-30 13:08
- Terrible… Helmut 2020-01-30 15:09
- Flawed evaluation accepted Helmut 2020-01-31 12:19
- Flawed evaluation accepted Mikalai 2020-01-31 12:40
- Flawed evaluation accepted Helmut 2020-01-31 14:17
- Flawed evaluation accepted Mikalai 2020-01-31 16:41
- Flawed approach even if accepted 😡 Helmut 2020-01-31 20:28
- Flawed approach even if accepted 😡 Mikalai 2020-02-01 16:18
- misunderstanding mittyri 2020-02-01 21:34
- misunderstanding Mikalai 2020-02-06 13:41
- misunderstanding mittyri 2020-02-06 16:23
- misunderstanding Mikalai 2020-02-06 13:41
- The globe is flat! d_labes 2020-02-05 19:16
- misunderstanding mittyri 2020-02-01 21:34
- Flawed approach even if accepted 😡 Mikalai 2020-02-01 16:18
- Flawed approach even if accepted 😡 Helmut 2020-01-31 20:28
- Flawed evaluation accepted Mikalai 2020-01-31 16:41
- Flawed evaluation accepted Helmut 2020-01-31 14:17
- Flawed evaluation accepted Mikalai 2020-01-31 12:40
- Tricky… wienui 2020-01-30 18:53
- Tricky… Helmut 2020-01-30 19:18
- Tricky… wienui 2020-02-03 07:10
- ABE vs. ABEL Helmut 2020-02-03 12:25
- zigzag d_labes 2020-02-05 18:53
- zigzag Helmut 2020-02-05 19:46
- zigzag Mikalai 2020-02-06 11:38
- helter-skelter Helmut 2020-02-06 20:12
- helter-skelter Mikalai 2020-02-10 16:10
- helter-skelter Helmut 2020-02-06 20:12
- zigzag Mikalai 2020-02-06 11:38
- zigzag Helmut 2020-02-05 19:46
- zigzag d_labes 2020-02-05 18:53
- ABE vs. ABEL Helmut 2020-02-03 12:25
- Tricky… wienui 2020-02-03 07:10
- Tricky… Helmut 2020-01-30 19:18
- Tricky… Mikalai 2020-01-30 13:08
- Tricky… Helmut 2020-01-30 12:07
- Inflation of the TIE as well zizou 2020-02-01 17:00
- Inflation of the TIE as well nobody 2020-02-01 23:30
- Inflation of the TIE as well Elena777 2020-03-10 19:28
- Fishing in the dark Helmut 2020-03-10 21:06
- Inflation of the TIE as well Elena777 2020-01-29 20:01
- Statistical evaluation and BE hypotheses in full replicate design nobody 2020-02-03 15:07
- TIE, repeat once more please... Astea 2020-04-02 12:41
- Inflation of the TIE as well Helmut 2020-01-29 15:38