Log in
RegisterFutility rule? [Study Assessment]
Hi Hötzi,
Haha, I don't know what to think. I was mainly addressing the numbers, hoping they reflected the actual and reported study results. Whether or not 81 equals 96 appears to be a subjective matter. But when women call their friends and tell you they are just going to chat for 5 minutes then you can, as a rule of thumb, be very sure that 5 equals 60 or more.
No doubt about that, and you are now almost too generously using terms from the positively charged heap. If my clients get a PE of 81% in a pilot then I would recommend that the plug be pulled. To be honest, I think this was a case of mild dumb luck.
Sam, I am not saying this to offend you, and if you take offence then I apologise and will offer to revise my post. But the decision to move forward after a pilot having PE=81% was simply a bad one from a scientific/ethical perspective, even though it in hindsight worked in your favour.
In the subsequent pilot-pivotal trial pair the opposite phenomenon was observed.
What I meant with the two-stage comment was that sometimes pilots do not reflect pivotals, and there could be different reasons for it. With OIPs, for example, products can change a lot over time and no-one really knows what this implies for the in vivo situation. But it suggests that sometimes the value of a pilot trial can be questionable if there is a large time span between the pilot and the pivotal (assuming same batches were used), and hence my question about this aspect.
❝ Same? Would you buy such a Bangkok Rolex-replica?
Haha, I don't know what to think. I was mainly addressing the numbers, hoping they reflected the actual and reported study results. Whether or not 81 equals 96 appears to be a subjective matter. But when women call their friends and tell you they are just going to chat for 5 minutes then you can, as a rule of thumb, be very sure that 5 equals 60 or more.
❝ Can you elaborate? I think it was very courageous to proceed with a PE of 81% for AUCt to a pivotal study.
No doubt about that, and you are now almost too generously using terms from the positively charged heap. If my clients get a PE of 81% in a pilot then I would recommend that the plug be pulled. To be honest, I think this was a case of mild dumb luck.
Sam, I am not saying this to offend you, and if you take offence then I apologise and will offer to revise my post. But the decision to move forward after a pilot having PE=81% was simply a bad one from a scientific/ethical perspective, even though it in hindsight worked in your favour.
In the subsequent pilot-pivotal trial pair the opposite phenomenon was observed.
What I meant with the two-stage comment was that sometimes pilots do not reflect pivotals, and there could be different reasons for it. With OIPs, for example, products can change a lot over time and no-one really knows what this implies for the in vivo situation. But it suggests that sometimes the value of a pilot trial can be questionable if there is a large time span between the pilot and the pivotal (assuming same batches were used), and hence my question about this aspect.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Regulatory Query for study repeat sam 2013-07-27 07:50
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Repeats ElMaestro 2013-07-27 11:01
- Repeats sam 2013-07-27 11:18
- Repeats ElMaestro 2013-07-27 11:31
- Repeats sam 2013-07-27 11:57
- Repeats ElMaestro 2013-07-27 12:27
- Repeats sam 2013-07-27 12:45
- Bad science Helmut 2013-07-27 14:15
- Bad science sam 2013-07-28 09:05
- Posting style & incomplete information Helmut 2013-07-28 12:32
- Posting style & incomplete information sam 2013-07-29 06:46
- RTFM! Helmut 2013-07-29 07:53
- RTFM! sam 2013-07-29 08:40
- copy & paste error or what? Helmut 2013-07-29 11:14
- copy & paste error or what? sam 2013-07-29 12:46
- copy & paste error or what? Helmut 2013-07-29 11:14
- Calm down! jag009 2013-07-29 16:06
- RTFM! sam 2013-07-29 08:40
- Slightly off-topic: The wonders of pilot trials ElMaestro 2013-07-29 09:19
- Futility rule? Helmut 2013-07-29 12:16
- Futility rule?ElMaestro 2013-07-29 12:46
- Slightly off-topic: The wonders of pilot trials sam 2013-07-29 12:41
- PE of AUC? Helmut 2013-07-29 12:45
- PE of AUC? sam 2013-07-29 12:56
- EOD Helmut 2013-07-29 13:18
- PE of AUC? sam 2013-07-29 12:56
- PE of AUC? Helmut 2013-07-29 12:45
- Futility rule? Helmut 2013-07-29 12:16
- Posting style & incomplete information jag009 2013-07-29 16:32
- Posting style & incomplete information sam 2013-07-30 06:08
- RTFM! Helmut 2013-07-29 07:53
- Posting style & incomplete information sam 2013-07-29 06:46
- Bad science ElMaestro 2013-07-28 12:43
- Posting style & incomplete information Helmut 2013-07-28 12:32
- Bad science sam 2013-07-28 09:05
- Repeats ElMaestro 2013-07-27 12:27
- Repeats jag009 2013-07-27 22:17
- Repeats ElMaestro 2013-07-27 23:11
- Repeats sam 2013-07-27 11:57
- Repeats ElMaestro 2013-07-27 11:31
- Repeats sam 2013-07-27 11:18
- Regulatory Query for study repeat jag009 2013-07-27 22:29
- Regulatory Query for study repeat sam 2013-07-29 12:36
- Regulatory Query for study repeat luvblooms 2013-07-30 08:28
- More questions.. jag009 2013-07-30 16:53
- Regulatory Query for study repeat luvblooms 2013-07-30 08:28
- Regulatory Query for study repeat sam 2013-07-29 12:36
- Repeats ElMaestro 2013-07-27 11:01
Ing. Helmut Schütz