General BE topics [Design Issues]

posted by VSL – India, 2017-06-06 21:34 (2487 d 16:15 ago) – Posting: # 17455
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Dear ElMaestro and Helmut,

Thank you very much for the explanation.

One more question, why regulatory agencies are allowing studies with deliberate high power? I mean, it is forced BE, unethical and violation of Declaration of Helsinki (Human exposure without scientific rationale). There has to be the scientific tradeoff in setting alfa and beta values while calculating sample size rather mere assumption. I have seen post analysis power more than 90% in many studies. If you ask biostatisticians, they say, we don't know, it comes, no justification is required as the study has passed.

Thank you again.

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