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RegisterPilot or pivotal ? [General Statistics]
Dear all,
» You want to get either T1 or T2 approved.
Isn't the common practice to first test T1 and T2 vs. R in a pilot study (and I will not get into a debate on whether alpha correction would be needed), select one of the two test formulations, and then test it in a pivotal study in the usual way ? How often do you see both test formulations directly tested in a pivotal study ?
OK, maybe if the product has a very low variability and the number of subjects remains very low, it could make sense and save time to directly go for the pivotal. Any experience ?
» You want to get either T1 or T2 approved.
T1 = R ∨ T2 = R: ⇒ 95% CI
In this case I argued for no adjustment (90% CI) in the past but nowadays I’m leaning towards an adjustment because which one will be marketed is part of a decision tree.Isn't the common practice to first test T1 and T2 vs. R in a pilot study (and I will not get into a debate on whether alpha correction would be needed), select one of the two test formulations, and then test it in a pivotal study in the usual way ? How often do you see both test formulations directly tested in a pivotal study ?
OK, maybe if the product has a very low variability and the number of subjects remains very low, it could make sense and save time to directly go for the pivotal. Any experience ?
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Decision of confidence interval of three period BE study libaiyi 2018-06-26 12:00 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Two tests and one reference Helmut 2018-06-26 13:13
- Two tests and one reference Brus 2020-08-31 09:58
- Two tests and one reference ElMaestro 2020-08-31 10:23
- Two regions: No α adjustment Helmut 2020-08-31 10:26
- Two regions: No α adjustment Brus 2020-08-31 11:09
- Two regions: different populations Helmut 2020-08-31 11:26
- Two regions: No α adjustment Brus 2020-08-31 11:09
- Two tests and one reference Brus 2020-08-31 09:58
- Decision of confidence interval of three period BE study ElMaestro 2018-06-26 22:20
- Any of two tests and one reference Helmut 2018-06-27 00:33
- Any of two tests and one reference libaiyi 2018-06-27 08:25
- Hey wait a moment.... ElMaestro 2018-06-27 08:29
- Hey wait a moment.... Helmut 2018-06-27 11:45
- Pilot or pivotal ?Ohlbe 2018-06-27 12:14
- Pilot or pivotal ? ElMaestro 2018-06-27 13:01
- Pilot or pivotal ? Ohlbe 2018-06-27 14:13
- Pilot or pivotal ? ElMaestro 2018-06-27 14:48
- Pilot or pivotal ? Ohlbe 2018-06-27 15:43
- Pilot or pivotal ? ElMaestro 2018-06-27 22:13
- Pilot or pivotal ? Ohlbe 2018-06-27 15:43
- Pilot or pivotal ? ElMaestro 2018-06-27 14:48
- Pilot or pivotal ? Ohlbe 2018-06-27 14:13
- Pilot or pivotal ? jag009 2018-06-29 20:53
- Pilot or pivotal ? ElMaestro 2018-06-29 22:11
- Pilot or pivotal ? jag009 2018-07-03 17:38
- Pilot or pivotal ? ElMaestro 2018-06-29 22:11
- Pilot or pivotal ? ElMaestro 2018-06-27 13:01
- Hey, hey wait another moment.... d_labes 2018-06-28 19:48
- Hey, hey wait another moment.... Helmut 2018-07-03 17:22
- Old belives die hard d_labes 2018-07-04 13:28
- Hey, hey wait another moment.... Helmut 2018-07-03 17:22
- Pilot or pivotal ?Ohlbe 2018-06-27 12:14
- Hey wait a moment.... Helmut 2018-06-27 11:45
- Any of two tests and one reference Helmut 2018-06-27 00:33
- Two tests and one reference Helmut 2018-06-26 13:13
Ing. Helmut Schütz