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Re: poorgradstudent post# 45065

Sunday, 04/15/2007 3:10:52 PM

Sunday, April 15, 2007 3:10:52 PM

Post# of 257443
>>> 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.

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