Acceptance of surrogate end points in clinical trials supporting approval of drugs for cancer treatment by the Japanese regulatory agency
Author:
Publisher
Elsevier BV
Subject
Oncology,Hematology
Reference25 articles.
1. Guideline for evaluation methods of anticancer drugs in Japan;Japan Antibiotics Research Association,1991
2. Endpoints for assessing drug activity in clinical trials;Pazdur;Oncologist,2008
3. Use of multiple endpoints and approval paths depicts a decade of FDA oncology drug approvals;Shea;Clin Cancer Res,2013
4. When are ‘Positive’ clinical trials in oncology truly positive?;Ocana;J Natl Cancer Inst,2011
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