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RegisterWhat the heck? [Two-Stage / GS Designs]
posted by Helmut 
– Vienna, Austria, 2012-07-03 21:25 (4680 d 11:32 ago) – Posting: # 8883
Views: 21,233
Hi ElMaestro!
At least that’s the first official statement that the FDA accepts sequential designs and prefers Potvin etc. Can revise my presentations from “personal communication with Barbara Davit”.
Precisely.
What the heck does the “if – then – without” part mean? Why should anybody want to submit the results of stage 1 if he/she/it has to proceed to stage 2? Any if not, what does “without using the sequential design constraints” mean? Unbelievable – with FDA’s Donald Schuirmann as co-author of both papers.
Reading between the lines my interpretation would be: FDA accepts a pilot study (classical design, n ≥ 12, properly planned and evaluated, etc.) demonstrating already BE. So the pilot is treated as a pivotal study. If a study passes in stage 1, FDA calls this one pivotal.
❝ I am reading FDA's draft guidance on Loteprednol, revised June 2012.
At least that’s the first official statement that the FDA accepts sequential designs and prefers Potvin etc. Can revise my presentations from “personal communication with Barbara Davit”.
❝ "[…] if there is no intention to separately submit to the Agency the results of the first group, then a second group may be enrolled following analysis of data from the first group, and statistical analysis conducted using “group” in the model without using the sequential design constraints."
❝
❝ Whiskey Tango Foxtrot?
Precisely.
❝ What does that mean for an applicant and does anyone have some insight into the logic behind it?
What the heck does the “if – then – without” part mean? Why should anybody want to submit the results of stage 1 if he/she/it has to proceed to stage 2? Any if not, what does “without using the sequential design constraints” mean? Unbelievable – with FDA’s Donald Schuirmann as co-author of both papers.
Reading between the lines my interpretation would be: FDA accepts a pilot study (classical design, n ≥ 12, properly planned and evaluated, etc.) demonstrating already BE. So the pilot is treated as a pivotal study. If a study passes in stage 1, FDA calls this one pivotal.
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Sequential designs, draft FDA guidance Loteprednol ElMaestro 2012-07-03 18:33 [Two-Stage / GS Designs]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- What the heck?Helmut 2012-07-03 19:25
- some unofficial opinion with this regard in Europe Shuanghe 2012-07-04 09:07
- Great! Helmut 2012-07-04 15:43
- Great! Shuanghe 2012-07-05 13:48
- Potvin & Montague not acceptable at all?! Helmut 2012-07-05 14:57
- Powerless Potvin & Montague? d_labes 2012-07-05 16:11
- Example w.o. intermediate power Helmut 2012-07-06 02:06
- Example w.o. intermediate power d_labes 2012-07-06 08:13
- Sims w.o. intermediate power Helmut 2012-07-26 16:20
- Example w.o. intermediate power Helmut 2012-07-06 02:06
- Potvin & Montague not acceptable at all?! ElMaestro 2012-07-05 16:20
- Sims? Helmut 2012-07-05 16:36
- Powerless Potvin & Montague? d_labes 2012-07-05 16:11
- Potvin & Montague not acceptable at all?! Helmut 2012-07-05 14:57
- Great! Shuanghe 2012-07-05 13:48
- Great! Helmut 2012-07-04 15:43
- some unofficial opinion with this regard in Europe Shuanghe 2012-07-04 09:07
- What the heck?Helmut 2012-07-03 19:25
Ing. Helmut Schütz