Performing Phase I Clinical Trials of Anticancer Agents: Perspectives from within the European Union and Japan

Drug discovery and early clinical development is an international endeavor, conducted in partnership between commercial entities such as biotechnology and pharmaceutical companies and academic investigators. Although once considered quite disparate, early clinical trials requirements and conduct are largely harmonized between the European Union, Japan, and the United States, increasing the opportunities for productive commercial-academic collaborations. Clin Cancer Res; 16( 6); 1737-44. (C) 2010 AACR.