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ratnakar1811 ★ India, 2008-09-01 10:53 (5748 d 10:11 ago) Posting: # 2292 Views: 7,725 |
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Dear Forum Members, Can anybody tell about the consideration of data of subjects for statistical analysis in a replicate design study (i.e. 4 period, 2 treatment, 2 sequence), whether we can consider the subjects who have not completed all four period (i.e. subjects completed 3 period, 2 or only 1 period of the study) or we have to consider subject who have completed all 4 periods of the study and what are the statistical implications and at the same time acceptance by regulatory bodies. Thanking you in advance. Ratnakar Jadhav |
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d_labes ★★★ Berlin, Germany, 2008-09-02 12:37 (5747 d 08:26 ago) @ ratnakar1811 Posting: # 2300 Views: 6,614 |
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Dear Ratnakar, ❝ […] whether we can consider the subjects who have not completed all four period (i.e. subjects completed 3 period, 2 or only 1 period of the study) or we have to consider subject who have completed all 4 periods of the study […] Since replicate studies are usually evaluated with SAS Proc MIXED (see FDA Guidance “Statistical Approaches to Establishing Bioequivalence” Appendix E for code) or equivalent software you can include subjects with missing data. But you have to assume that these missings are missings at random. For “missings at random” or “completely missing at random” Goooogle is your friend. To my restricted knowledge no regulatory body will have concerns if you include subjects with missing data in your statistical analysis. Except of course that missing data are not the rule, which will shed doubt on the quality of the performance of your study. Quite the contrary you will have to justify why you have not included certain subject. The Draft of the EMEA guideline explicitly states: “All treated subjects should be included in the statistical analysis, with the exception of subjects in a crossover trial who do not complete at least one period …” — Regards, Detlew |
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ratnakar1811 ★ India, 2008-09-02 15:42 (5747 d 05:21 ago) @ d_labes Posting: # 2302 Views: 6,578 |
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Dear Labes, I hope I have written your name correctly. Thanks for your information. If anybody else has some more information regarding the same he can also share with me. Tanking you, Ratnakar |
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ratnakar1811 ★ India, 2008-09-02 16:34 (5747 d 04:29 ago) @ ratnakar1811 Posting: # 2303 Views: 6,563 |
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Dear Labes and forum members, AS per the draft guideline which mentions that, "All treated subjects should be included in the statistical analysis, with the exception of subjects in a crossover trial who do not complete at least one period receiving each of the test and reference products (or who fail to complete the single period in a parallel group trial)." which i guess, means that in a crossover trial if it is a two period study subject should complete both the periods and in case of replicate study subject should complete at least two periods receiving test and reference at least once can be considered. Comment! Ratnakar Jadhav |
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d_labes ★★★ Berlin, Germany, 2008-09-02 18:33 (5747 d 02:30 ago) @ ratnakar1811 Posting: # 2307 Views: 6,625 |
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— Regards, Detlew |
Ing. Helmut Schütz