Bioequivalence and Bioavailability Forum

Hi Dennis,

❝ ❝ 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.

It is the job of the IEC/IRB to make a benefit/risk-assessment for the subjects in the study. To assess a potential socio-econommic advantage for the health system is not in the job description of the members.

❝ Is there any other probelm for the design?

IMHO, ethics.

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• 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’.