Impact of a Biomarker-Based Strategy on Oncology Drug Development: A Meta-analysis of Clinical Trials Leading to FDA Approval.

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Published in J Natl Cancer Inst on September 15, 2015

Authors

Denis L Jardim1, Denis L Fontes Jardim1, Maria Schwaederle2, Caimiao Wei2, J Jack Lee2, David S Hong2, Alexander M Eggermont2, Richard L Schilsky2, John Mendelsohn2, Vladimir Lazar2, Razelle Kurzrock1

Author Affiliations

1: Department of Clinical Medicine, Hemocentro da Unicamp, University of Campinas, Sao Paulo, Brazil (DLFJ); Department of Clinical Oncology, Hospital Sirio Libanes, Sao Paulo, Brazil (DLFJ); Center for Personalized Cancer Therapy and Division of Hematology and Oncology, University of California, San Diego, CA (MS, RK); Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX (CW, JJL); Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX (DSH); Department of Functional Genomics, Institut Gustave Roussy, University Paris-Sud, Villejuif, France (AME, VL); Worldwide Innovative Network in Personalized Cancer Medicine, Villejuif, France (AME, RLS, JM, VL, RK); American Society of Clinical Oncology, Alexandria, VA (RLS); The University of Texas MD Anderson Cancer Center, Houston, TX (JM). rkurzrock@ucsd.edu jardimde@gmail.com.
2: Department of Clinical Medicine, Hemocentro da Unicamp, University of Campinas, Sao Paulo, Brazil (DLFJ); Department of Clinical Oncology, Hospital Sirio Libanes, Sao Paulo, Brazil (DLFJ); Center for Personalized Cancer Therapy and Division of Hematology and Oncology, University of California, San Diego, CA (MS, RK); Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX (CW, JJL); Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX (DSH); Department of Functional Genomics, Institut Gustave Roussy, University Paris-Sud, Villejuif, France (AME, VL); Worldwide Innovative Network in Personalized Cancer Medicine, Villejuif, France (AME, RLS, JM, VL, RK); American Society of Clinical Oncology, Alexandria, VA (RLS); The University of Texas MD Anderson Cancer Center, Houston, TX (JM).

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