Can Disease-Free Survival Be a Surrogate for Overall Survival for Drug Approvals?
نویسندگان
چکیده
منابع مشابه
Can disease-free survival be a surrogate for overall survival for drug approvals?
The gold standard test for clinical benefit of oncology drugs is improvement in overall survival. The U.S. Food and Drug Administration allows drugs to be approved if they improve patient survival or if there is evidence that reliably predicts clinical benefit, such as an established surrogate. In a recent analysis of the 57 oncology drug applications approved in the last 13 years through the r...
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BACKGROUND Progression-free survival (PFS) and time to progression (TTP) are frequently used to establish the clinical efficacy of anti-cancer drugs. However, the surrogacy of PFS/TTP for overall survival (OS) remains a matter of uncertainty in metastatic breast cancer (mBC). This study assessed the relationship between PFS/TTP and OS in mBC using a trial-based approach. METHODS WE CONDUCTED ...
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ژورنال
عنوان ژورنال: JNCI Journal of the National Cancer Institute
سال: 2004
ISSN: 0027-8874,1460-2105
DOI: 10.1093/jnci/96.3.173