title: Advances in Statistical Approaches Oncology Drug Development.
abstract: We describe some recent developments in statistical methodology and practice in oncology drug development from an academic and an industry perspective. Many adaptive designs were pioneered in oncology, and oncology is still at the forefront of novel methods to enable better and faster Go/No-Go decision making while controlling the cost.
authors.affiliation: Department of Biostatistics, University of North Carolina at Chapel Hill, NC, USA.
authors.forename: Anastasia
authors.initials: A
authors.lastname: Ivanova
authors.affiliation: Oncology Biostatistics & Bioinformatics, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
authors.forename: Gary L
authors.initials: GL
authors.lastname: Rosner
authors.affiliation: CSDD, Innovation, Quintiles, Durham, NC, USA.
authors.forename: Olga
authors.initials: O
authors.lastname: Marchenko
authors.affiliation: Tessella, Abingdon, Oxfordshire, England.
authors.forename: Tom
authors.initials: T
authors.lastname: Parke
authors.affiliation: Statistical Research and Consulting Center, Pfizer, Inc., Collegeville, PA, USA.
authors.forename: Inna
authors.initials: I
authors.lastname: Perevozskaya
authors.affiliation: Biometrics and Advanced Analytics, Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Yanping
authors.initials: Y
authors.lastname: Wang
keywords: MTD; cancer trial; model-based design; oncology drug development; stopping rule