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Future clinical trials could also use measurements of such levels as a surrogate endpoint of efficacy.
Thus, the current study evaluated clinical benefit response as an endpoint of efficacy.
The main endpoint of efficacy was a "success" (i.e. no further nausea or vomiting in a nauseated or vomiting patient).
The American College of Rheumatology 20/50/70% Response Criteria was utilized as the primary endpoint of efficacy.
The second aspect is more challenging and important; can the biomarker predict the clinical endpoint of efficacy and serve as a surrogate endpoint?
The recent announcement that SYMPLICITY HTN-3 failed to reach its primary endpoint of efficacy confirms the need for a radically different approach.
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These can be a family of primary safety endpoints, of secondary safety endpoints, of efficacy on subgroups, and so on.
We review the current literature for results of imaging endpoints of efficacy and safety in published clinical trials.
As this was primarily a safety study no formal a-priori power calculation was conducted for secondary endpoints of efficacy.
The development of ipilumumab brought up interesting ques-tions about the best endpoints of efficacy assessment for this class of agents.
This review concentrated on dichotomous outcomes reflecting clinically relevant endpoints of efficacy and harm, and included four atypical antipsychotics over the short, medium, and long term, with trials included if they were published up to December 2006.
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