Replies to post #104573 on Innovation Pharmaceuticals Inc (IPIX)

[To infinity and beyond!]

A control group getting usual care is the standard for any proof of efficacy. You must prove it works in people and not just in the lab and, you also must show there are no serious side effects.

I agree with you that I would not want to be in the control group for this trial!

[thefamilyman]

Those were my thoughts as well...

Their's already tons of data about what the approx. percentage is of untreated patients who will get OM during chemo/rad. treatments. Why have a placebo group at all? Especially since you can't really predict who will and who will not get OM. Probably showing my lack of understanding of these things...
- Darwinian

[Pepperchino]

Thinking they would have an arm where B and the placebo aren't administered until after symptoms first appear to ensure a response.

[frrol]

Since there's no standard of care for OM, it's a non-lethal indication, and its occurrence is random, I suppose a placebo arm is what you should use as the control group.

[BonelessCat]

The control is used to measure efficacy by directly comparing the points of measure. For example two points of measure are lesion reduction and use of gastrostomy tubes. It's difficult to know if lesion size or numbers are actually decreased without comparing the treated group size and number to the control group. Or, compare the number of times a gastrostomy tube was needed. In an area of unmet need, efficacy can be nothing more than reducing the severity and size of lesions, and not an all or none approach that many think in terms of treatment. So, if the treated group showed fewer lesions per patient and only required a gastrostomy tube for 3 cases of 20 rather than 6 seen in the untreated group, the placebo arm provides that direct measure of reduction for treated patients. Without the comparison arm, one might think a treatment ineffective because there were individuals still showing lesions or rquiring feeding tubes following chemo and radiation. It's the comparison that provides the measurement (proof) for increased comfort, life quality and pain reduction, that is the placebo helps quantify otherwise qualitative assessments.