When early dropouts are classified as non-responders, Studies 009 and 011 meet the criteria for the categorical endpoint but Study 010 does not.
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The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least six months.
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The analysis of overall survival (OS), a key secondary endpoint of the study, is event driven.
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Merck announced today that the HPS2-THRIVE ( H eart P rotection S tudy 2- T reatment of H DL to R educe the I ncidence of V ascular E vents) study did not meet its primary endpoint.
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Patients don't care if a drug meets the original primary endpoint of Dendreon's study, an improvement in X-rays, says Penson.
It's unlikely Schering and Merck knew the full results of the study and suppressed them, otherwise they would never have made a controversial decision to change the study's main goal or primary endpoint.
In other words, the study lost because of the choice of primary endpoint.
The press release issued last week said the study failed to show a benefit on the changed endpoint as well.
This study, however imperfect because of its focus on a surrogate endpoint, demonstrates why we need to generate more information about how drugs compare.
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"The independent panel recommended focusing the primary endpoint to the common carotid artery to expedite the reporting of the study findings, " the companies said in a press release Nov. 19.
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