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Yura ★ Belarus, 2016-01-13 07:51 (3393 d 05:05 ago) Posting: # 15817 Views: 6,658 |
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Hi How to calculate the sample size for the non-comparative trials for biosimilar, or what are the approaches to solving this problem? Aim - assessment of treatment effectiveness (improvement in symptoms). Best regards, Yura |
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BE-proff ● 2016-01-14 12:15 (3392 d 00:40 ago) @ Yura Posting: # 15826 Views: 5,414 |
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Hi Yura, IMHO, the best option is to involve qualified statistician who has an experience in such calculations. |
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Dr_Dan ★★ Germany, 2016-01-14 14:37 (3391 d 22:18 ago) @ Yura Posting: # 15827 Views: 5,344 |
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Dear Yura In a non-controlled (non-comparative) study no control/comparative group (in which subjects are given comparator drug) is used. Is it this what you mean? Pilot study for Proof-of-Concept to evaluate if some Parameters change? This would be an exploratory study and no formal sample size calculation would be needed. If you want to assess treatment efficacy you need to compare to something (placebo, comparator drug or no treatment at all) and for such a (confirmatory) study you can make a sample size calculation based on the desired outcome (non-inferiority, equivalence or superiority). Please advise. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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Yura ★ Belarus, 2016-01-15 09:53 (3391 d 03:02 ago) @ Yura Posting: # 15828 Views: 5,343 |
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Hi There are data in which the effectiveness of the similar biological product up to 80%. Can we compare the test biological product with these data and how should be the size of the sample? Best regards, Yura |
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Dr_Dan ★★ Germany, 2016-01-18 18:17 (3387 d 18:38 ago) @ Yura Posting: # 15838 Views: 5,149 |
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Dear Yura Sorry, but with such sparse information it is not possible to help. In general you will need at least the following Information:
Dr_Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz