Searching for potential surrogate endpoints of overall survival in clinical trials for patients with prostate cancer

Author:

Maeda Hideki1ORCID,Takeda Kentaro2,Urushihara Hisashi3,Kurokawa Tatsuo3

Affiliation:

1. Department of Regulatory Science, Faculty of Pharmacy Meiji Pharmaceutical University Kiyose‐city Tokyo Japan

2. Biostatistics Group, Data Science Department Astellas Pharma Global Development, Inc Northbrook Illinois USA

3. Division of Drug Development & Regulatory Science, Faculty of Pharmacy Keio University Minato‐ku Tokyo Japan

Publisher

Wiley

Subject

Cancer Research,Oncology

Reference30 articles.

1. Fool’s gold, lost treasures, and the randomized clinical trial

2. Food and Drug Administration Center for Drug Evaluation and Research Center for biologics Evaluation and Research.Guidance for industry. Clinical trial endpoints for the approval of cancer drugs and biologics.2007.http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf. Accessed August 16 2020

3. Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs

4. Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval

5. Acceptance of surrogate end points in clinical trials supporting approval of drugs for cancer treatment by the Japanese regulatory agency

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