Replies to post #119891 on Biotech Values

[mouton29]

Randomized experience:

Must be referring to no prior randomized trial, i.e., one in which one arm gets the experimental treatment and the other standard of care. I assume you are not suggesting that randomized trials are unnecessary in oncology or other diseases whether the outcome is "measured."

[acgood]

BSR David

i guess by randomized experience you might also mean - distrust of management and clinicians that were involved in the trials thus far....otherwise i can not understand why randomized experience should have any meaning - its not like you are treating a flu patient - you are treating a cancer patient and the outcome is measured.

DFRAI- see, for example, Cell Genesys as to why that is a bad idea, for investors AND patients

[AlpineBV_Miller]

When treating patients with a new drug in combination with existing drugs, how do you separate the new drug's treatment effect? Management teams will point to historical data, but that is NOTORIOUSLY unreliable for either powering a pivotal trial or determining whether a new drug added to some existing drug has clinical efficacy.

The way you figure this out is to run randomized trials. When I say "no randomized experience" I mean no experience in a randomized trial to know for sure the magnitude of difference in efficacy, if any, between the existing drug and the new drug in combination with the existing drug.

Without randomized trials, management teams (and shareholders) are only guessing at the magnitude of benefit when powering their pivotal trial. This leads to underpowered trials that fail.

It has nothing to do with trusting management or the clinicians. It has to do with the right way and the wrong way to conduct a clinical program to maximize success.

David