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balakotu ★ India, 2014-11-28 09:26 (3794 d 00:23 ago) Posting: # 13941 Views: 4,280 |
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Dear all, We are planning to conduct a bioequivalence study with sufficient number of subjects (N=50). After clinical phase, we will complete bioanalysis for first 50% of subjects. Then, we do pharmacokinetic and statistical analysis for the 50% data (N=25 subjects). If CV is less and ratios is close to but not within the limits of 80-125%, then we want to continue the study with bioanalysis of remaining 50% subjects (N=25) and construct 90% CI at alpha=5% for entire data (N=50). With the first 50% data, if CV is high and ratios are very much beyond the limits of 80-125%, then we want to stop the bioanalysis and study. Whether this procedure is acceptable or not? Please clarify. Thanks&Regards Kotu |
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Mahesh M ★ India, 2014-11-28 09:54 (3793 d 23:55 ago) @ balakotu Posting: # 13942 Views: 3,485 |
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Dear Kotu, Interim analysis is not accepted by any regulatory. Only two stage design is allowed for the same. (Must be pre-defined in protocol) Regards |
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Ohlbe ★★★ France, 2014-11-28 15:15 (3793 d 18:34 ago) @ Mahesh M Posting: # 13951 Views: 3,455 |
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Dear Mahesh and Kotu, ❝ Interim analysis is not accepted by any regulatory. ❝ Only two stage design is allowed for the same. (Must be pre-defined in protocol) If I understand well the idea is only to test for futility. This is unusual in BE trials, but common practice in Phase III trials. The futility test should be described in the protocol submitted to the Ethics Committee. What I think would not be acceptable to Agencies (at least in Europe) would be to dose all 50 subjects, collect all samples, analyse the samples of the first 25 subjects, conclude that bioequivalence is demonstrated, and not analyse the samples of the remaining 25 subjects. — Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2014-11-28 15:21 (3793 d 18:28 ago) @ Ohlbe Posting: # 13952 Views: 3,473 |
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Dear all, ❝ If I understand well the idea is only to test for futility. This is unusual in BE trials, but common practice in Phase III trials. The futility test should be described in the protocol submitted to the Ethics Committee. Correct. Since to my knowledge nothing is published yet, perform simulations before the study in order to demonstrate that the patient’s risk (type I error) is maintained. Hint: The ![[image]](img/uploaded/Rlogo_15_12.svg) -package Power2Stage.❝ What I think would not be acceptable to Agencies (at least in Europe)… Correct again. BE-GL, Subject accountability: The data from all treated subjects should be treated equally. […] It should be planned that all treated subjects should be included in the analysis […]. — 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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priya ☆ India, 2014-11-28 14:41 (3793 d 19:08 ago) @ balakotu Posting: # 13948 Views: 3,460 |
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Hi Balakotu, No regulatory agencies recommends interim analysis. You can go for Sequential design but not for interim analysis of first set of subjects and analyzing the remaining set of subjects. FDA's Old guidance states that "A sequential design, in which the decision to study a second group of subjects is based on the results from the first group, calls for different statistical methods. Those wishing to use a sequential design should consult the appropriate CDER review division. I will raise so many concerns if you go for interim analysis of samples. Priya. |
Ing. Helmut Schütz