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Of the 368 patients evaluable for clinical benefit response, 21 percent of the Alimta/cisplatin patients and 14 percent of cisplatin patients were considered responders.
In designing clinical trials for Gemzar, Lilly developed a new and unique clinical endpoint, clinical benefit response, to objectively assess the effect of Gemzar on measured disease-related symptoms.
The primary endpoint for the Phase 2b 003-A1 pivotal study is overall response rate, and secondary endpoints include clinical benefit response, duration of response, progression-free survival, time-to-progression, overall survival and safety.
The studies measured tumor shrinkage, survival, and an overall estimate of clinical benefit response rate.

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