Non-Superiority [Design Issues]
❝ ❝ You hope that the complication rates in group A (with medicine) are lower than in group B (without medicine), right?
❝ However, we try to show the complication rates in group B (without medicine) are lower (or not worse or non-inferiority) than in group A (with medicine), …
Essentially you are trying to show that the medicine doesn’t perform better than placebo (assuming the study is double-blind).
❝ … duo to the medicine is very expensive.
Likely you will face problems with the IEC/IRB:
- The – traditional* – medicine is approved (I guess). The fact that it is expensive is not relevant.
- While it would be acceptable to administer yet another treatment (hoping that it performs at least as good as the standard whilst still being cheaper), administering just nothing is unacceptable.
❝ Is there any other probelm for the design?
- 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’.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
The quality of responses received is directly proportional to the quality of the question asked. 🚮
- Could we design the RCT as a non-inferiority trial at this situation? dennis001 2022-07-24 17:39 [Design Issues]
- Non-Superiority Helmut 2022-07-25 16:37
- 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