Sequential trial with B method of Potvin [Two-Stage / GS Designs]
Hi JJ,
I would go by the metric that displays the highest variance, which is usually Cmax. I suggest to proceed towards stage 2 on that basis.
However, since this was not pre-specified it is your protocol that document may be your biggest issue now; regulators may not like whatever decision you take.
❝ In a sequential clinical trial conducted like a B method of Potvin, we have Cmax and AUC both not bioequivalent. Cmax has a power <80% (71.5%), and AUC>80% (84.6%).
❝ AUC 0-30min calculated by protocol is bioequivalent.
❝ In the protocol it was not specified how to proceed in this situation.
❝
❝ Can we calculate a new n and pass to the second phase? Or we must stop the trial?
I would go by the metric that displays the highest variance, which is usually Cmax. I suggest to proceed towards stage 2 on that basis.
However, since this was not pre-specified it is your protocol that document may be your biggest issue now; regulators may not like whatever decision you take.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Sequential trial with B method of Potvin john john 2015-10-01 17:44 [Two-Stage / GS Designs]
- Sequential trial with B method of PotvinElMaestro 2015-10-01 17:58
- Sequential trial with B method of Potvin Helmut 2015-10-01 18:13
- Sequential trial with B method of Potvin john john 2015-10-07 11:26
- Power to the people d_labes 2015-10-07 13:49
- Power to the people john john 2015-10-07 14:54
- Software? Ethics beyond statistics… Helmut 2015-10-07 16:06
- Subtraction of a df ElMaestro 2015-10-07 21:22
- df = df-1 d_labes 2015-10-08 08:10
- Subtraction of a df ElMaestro 2015-10-07 21:22
- Software? Ethics beyond statistics… Helmut 2015-10-07 16:06
- Power to the people john john 2015-10-07 14:54
- Potvin B: α 0.0294 in both stages Helmut 2015-10-08 15:27
- Potvin B: α 0.0294 in both stages john john 2015-10-23 12:04
- Power to the people d_labes 2015-10-07 13:49
- Sequential trial with B method of Potvin john john 2015-10-07 11:26