Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration's Approval of Oncology Drugs

Sipuleucel-T Immunotherapy for Castration-Resistant Prostate Cancer

Philip W. Kantoff, Celestia S. Higano, Neal D. Shore et al. · New England Journal of Medicine · 2010 · 5.4K citations · Full text

Paclitaxel plus Bevacizumab versus Paclitaxel Alone for Metastatic Breast Cancer

Kathy D. Miller, Molin Wang, Julie R. Gralow et al. · New England Journal of Medicine · 2007 · 3K citations · Full text

U.S. Government Accountability Office

Choice Reviews Online · 2013 · 999 citations

Public Policy, Government Transparency, Accountability +2

Statistical validation of intermediate endpoints for chronic diseases

Laurence S. Freedman, Barry I. Graubard, Arthur Schatzkin · Statistics in Medicine · 1992 · 644 citations

The validation of surrogate endpoints in meta-analyses of randomized experiments

Marc Buyse, Geert Molenberghs, Tomasz Burzykowski et al. · Biostatistics · 2000 · 585 citations · Full text

Cancer Management, Clinical Endpoint, Research Ethics +18