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Helmut ★★★   Vienna, Austria, 2013-05-19 21:11 (4768 d 09:52 ago) Posting: # 10602 Views: 4,773 |
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Dear all, does anybody know where I can find the latest release? Version 5 (July 2012) of the Q&A contains this goodie: Q2: In case of 2 stage design study, how many subjects are recommended to start with in the first stage? If the first stage can reach BE, but the intra subject CV is high and the number of subjects is not enough to obtain the required statistical power, are additional subjects still needed? Given this thread I’m really curious what Section 3.1.8 might tell. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Helmut ★★★ Vienna, Austria, 2013-05-20 17:15 (4767 d 13:47 ago) @ Helmut Posting: # 10605 Views: 3,746 |
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Dear all, in the meantime I have received the May 2012 draft from Jiři (THX!). Section 3.1.8 is 1:1 with EMA’s 4.1.8. Crazy that they carried over the ±20% expected deviation from the 2009 Q&A v2 (see also this thread) to Section 3.1.3, which reads: The number of subjects to be included in the study should be based on an appropriate sample size calculation.
The clinical and analytical standards imposed may also influence the statistically determined number of subjects. However, generally the minimum number of subjects should not be smaller than 12. Funny that the Q2 from above is not answered at all. Still interested in the URL which I could add to the Guidelines. — 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 |
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Ken Peh ★ Malaysia, 2013-05-20 21:34 (4767 d 09:29 ago) @ Helmut Posting: # 10608 Views: 3,679 |
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Dear Helmut, The ASEAN guideline 2013 will soon be out. The final draft has been circulated for comments by ASEAN members. I brought up the case of delta, ie percentage difference from 100 % ie. ±20%)to the committee. I forward to the committee the example that you calculated and shown to us in previous thread using PowerTOST on the sample size. The committee promised to look into it. Let us wait if it has been changed to ±5%. Thank you. Regards, Ken Peh |
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Helmut ★★★ Vienna, Austria, 2013-05-21 16:02 (4766 d 15:01 ago) @ Ken Peh Posting: # 10611 Views: 3,620 |
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Hi Ken! ❝ I brought up the case of delta […]. The committee promised to look into it. Let us wait if it has been changed to ±5%. Hopefully they will write i.e. ±5%. Since this is the expected deviation it can be another value as well (<20% of course…). Essentially they could simply keep the wording of the 2004 final draft. — 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 |
Ing. Helmut Schütz