Replies to post #3547 on Dendreon Corp fka DNDNQ

[walldiver]

Patients in each arm have the option of getting a treatment that the FDA says is already proven to extend survival (Taxotere). So to the FDA, this satisfies the ethics question.

[gofishmarko]

The crossover requirement for ethical concerns is a Catch-22 that only bureaucrats and Joseph Heller could love.

Any drug in a clinical trial to determine efficacy is , by definition , of unknown efficacy , therefore it's not unethical to withhold it from placebo arm patients. If you know it's efficacious , why are you running the trial ? If it's unethical to withhold from trial participants , how is it ethical to withhold it from everyone else ?

What IS unethical is to allow crossover designs to so confound results that a truly efficacious drug is never approved because of an inability to generate sufficiently soothing statistics. Not to mention that such trials must always be larger than they would be for a non-crossover design if they are to have any chance of succeeding , thus depleting the pool of needed trial enrollees for other potentially lifesaving drugs in development.

This from the same group of people who happily approve drugs based on surrogate endpoints ( soothing stats ! ) even when they have no freakin' idea whether the drug provides a true clinical benefit. They'll know whether it's truly beneficial only after running the post-approval P4 study , assuming the crossover design doesn't muck things up too much , of course.

[froggmister]

If in fact the FDA wants approve on the existing data but wants some data to confirm and pull the drug if it fails to be efficacious, would it be possible to amend the SPA to vacate the placebo arm and use Halabi while still tracking those that got the drug?