Hypotheses in non-inferiority trials [Power / Sample Size]
Hi Outlaw Torn
Let me cite Emmanuel Lesaffre:
"Demonstrating non-inferiority necessitates rejecting the null hypothesis (H0: ∆ > ∆NI) in favor of the alternative hypothesis (HA: ∆ < ∆NI) with an adapted classical statistical test (as for an equivalence test). A significant result (p < 0.025) means, in this case, that the experimental treatment is not (much) worse, i.e., non-inferior, to the control treatment, whereby the conclusion “non-inferior” depends on the chosen value for ∆NI."
I highly recommend you to read his great article (for me it's the best one). I think the relationships between equivalence, non-inferiority and superiority will be more clear.
❝ What I'm getting at is this. When conducting a non-inferiority trial, are the roles of the type-I and type-II error rate reversed since the null hypothesis and the alternative hypothesis are reversed (Null Hypothesis H0 states non non-inferiority (i.e. inferiority) while Alternative Hypothesis H1 states non-inferiority between Test and Reference products)?
Let me cite Emmanuel Lesaffre:
"Demonstrating non-inferiority necessitates rejecting the null hypothesis (H0: ∆ > ∆NI) in favor of the alternative hypothesis (HA: ∆ < ∆NI) with an adapted classical statistical test (as for an equivalence test). A significant result (p < 0.025) means, in this case, that the experimental treatment is not (much) worse, i.e., non-inferior, to the control treatment, whereby the conclusion “non-inferior” depends on the chosen value for ∆NI."
I highly recommend you to read his great article (for me it's the best one). I think the relationships between equivalence, non-inferiority and superiority will be more clear.
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- The power of post hoc power The Outlaw Torn 2015-05-13 12:49 [Power / Sample Size]
- The power of post hoc power ElMaestro 2015-05-13 17:53
- Ad hoc power d_labes 2015-05-13 20:18
- Ad hoc power The Outlaw Torn 2015-05-14 11:38
- Ad hoc power The Outlaw Torn 2015-06-15 11:20
- Hypotheses in non-inferiority trialsmittyri 2015-06-16 21:52
- Hypotheses in non-inferiority trials The Outlaw Torn 2015-06-17 11:35
- Hypotheses in non-inferiority trials d_labes 2015-06-18 10:17
- Hypotheses in non-inferiority trials The Outlaw Torn 2015-06-22 10:23
- Hypotheses in non-inferiority trials arjunroy 2015-06-29 08:24
- Hypotheses in non-inferiority trials The Outlaw Torn 2015-06-22 10:23
- Hypotheses in non-inferiority trials d_labes 2015-06-18 10:17
- Hypotheses in non-inferiority trials The Outlaw Torn 2015-06-17 11:35
- Hypotheses in non-inferiority trialsmittyri 2015-06-16 21:52
- Ad hoc power The Outlaw Torn 2015-06-15 11:20
- Ad hoc power The Outlaw Torn 2015-05-14 11:38
- Ad hoc power d_labes 2015-05-13 20:18
- The power of post hoc power ElMaestro 2015-05-13 17:53