Bioequivalence and Bioavailability Forum • Non-Superiority

Non-Superiority [Design Issues]

posted by dennis001 – Hong Kong, 2022-07-27 07:18 (632 d 11:25 ago) – Posting: # 23180
Views: 2,061

Dear Helmut

Thanks!

❝ Essentially you are trying to show that the medicine doesn’t perform better than placebo (assuming the study is double-blind).

Thank you for your comment.
But I have to confess that I'm a little bit confused.
Dose the effect of placebo could be consided as the effect of patinets without medicine in the situation of our study?
that is, the effect of patinets with placebo equal to the effect of patinets without medicine in our study?

❝ IMHO, ethics.

It's very important for our study.

❝ Can you elaborate a bit – without naming the good stuff – what ‘traditional’ means in this context? Any studies demonstrating its efficacy & safety? Or ‘traditional’ like ‘It’s used for ages and obviously [sic] it works’.

Yes.
The medicine is a common prescription medications.

Complete thread:

Could we design the RCT as a non-inferiority trial at this situation? dennis001 2022-07-24 17:39
- Non-Superiority Helmut 2022-07-25 16:37
  - Non-Superiority dennis001 2022-07-26 02:32
    - Non-Superiority Helmut 2022-07-26 15:04
      - Non-Superioritydennis001 2022-07-27 05:18
        
        Placebo effect Helmut 2022-07-27 12:17
- Could we design the RCT as a non-inferiority trial at this situation? ElMaestro 2022-07-26 12:44
  - Could we design the RCT as a non-inferiority trial at this situation? dennis001 2022-07-27 05:21