Acceptance of surrogate end points in clinical trials supporting approval of drugs for cancer treatment by the Japanese regulatory agency
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Acceptance of surrogate end points in clinical trials supporting approval of drugs for cancer treatment by the Japanese regulatory agency.
BACKGROUND This study investigated the historic use of different end points to support approval of drugs for cancer treatment in Japan. PATIENTS AND METHODS Anticancer drugs approved between April 2001 and April 2014 were comprehensively investigated using publicly available information. RESULTS Before the revision of the guideline for oncology drugs in April 2006 in Japan, >80% of end poin...
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ژورنال
عنوان ژورنال: Annals of Oncology
سال: 2015
ISSN: 0923-7534
DOI: 10.1093/annonc/mdu500