Open AccessBlinded Independent Central Review of the Progression‐Free Survival Endpoint
Author(s) -
Amit Ohad,
Bushnell Will,
Dodd Lori,
Roach Nancy,
Sargent Daniel
Publication year - 2010
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2009-0261
Subject(s) - medicine , food and drug administration , audit , clinical endpoint , medical physics , oncology , intensive care medicine , family medicine , clinical trial , pharmacology , accounting , business
Presented are the efforts of the Pharmaceutical Research and Manufacturing Association PFS Working Group to address concerns related to blinded independent central review of locally evaluated progression times and the proposed audit methodology to minimize potential biases, along with the U.S. Food and Drug Administration's comments on this work.