Exaggeration of PFS by blinded, independent, central review (BICR)
نویسندگان
چکیده
منابع مشابه
Assessment of audit methodologies for bias evaluation of tumor progression in oncology clinical trials.
As progression-free survival (PFS) has become increasingly used as the primary endpoint in oncology phase III trials, the U.S. Food and Drug Administration (FDA) has generally required a complete-case blinded independent central review (BICR) of PFS to assess and reduce potential bias in the investigator or local site evaluation. However, recent publications and FDA analyses have shown a high c...
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Progression-free survival is an important end point in advanced disease settings. Blinded independent central review (BICR) of progression in randomized clinical trials has been advocated to control bias that might result from errors in progression assessments. However, although BICR lessens some potential biases, it does not remove all biases from evaluations of treatment effectiveness. In fac...
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ژورنال
عنوان ژورنال: Annals of Oncology
سال: 2019
ISSN: 0923-7534
DOI: 10.1093/annonc/mdy514