Advances in Statistical Approaches Oncology Drug Development

Ther Innov Regul Sci. 2014 Jan;48(1):81-89. doi: 10.1177/2168479013501309.


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.

Keywords: MTD; cancer trial; model-based design; oncology drug development; stopping rule.