Replies to post #45065 on Biotech Values

[gofishmarko]

>>> So if a drug gets on the market because of its effect on a surrogate, then it is reasonable to provide a framework to allow the sponsor to test survival. <<<

And according to the argument advanced by yourself and Dew , the best framework to accomplish this would be a CU program while the confirmatory trial is ongoing , so as not to allow full marketing of drugs that may turn out to have no clinical benefit.

For the life of me I can't see what I'm missing here.

A surrogate marker trial success is a " hypothesis generating " result that has a reasonable chance of predicting a clinical benefit.

A close miss on a survival result is exactly the same thing , but with a better chance of ultimately demonstrating that benefit , because no assumptions have be be made about the connection between the outcome measured and the desired outcome.

[AlpineBV_Miller]

DNDN, tangentially... I do think that this type of hyper-aware patient that tries to completely game the clinical trial system is the exception.</>

Patient groups in both the Nexavar RCC trial and the Sutent GIST trial cracked open the capsules and figured out by the color which were real and not. Never underestimate the ability of patients faced with death to work the system.

Incidentally, this was disclosed in a panel meeting with Pazdur in attendance and essentially meant the blind in the trial was broken from the very beginning. Both drugs were given full approval even though their SPAs said accelerated approval only on the initial surrogate endpoints.