title: Integrating biomarkers in colorectal cancer trials in the West and China.
abstract: The discovery of biomarkers that provide information on drug efficacy is recognized as essential for successful and cost-effective treatment of cancer. However, biomarker discovery is difficult, and requires multiple independent studies to identify a target that serves as a suitable predictor of efficacy and to ensure appropriate biomarker validation. Clinical trials that are performed, sometimes sequentially, in Europe, the USA or Asia, are often similar in their design, in part owing to regulatory, marketing, or safety considerations. We believe some of these trials offer additional unique opportunities for biomarker discovery or validation. There are multiple hurdles to overcome, such as homogenous tissue acquisition and analysis, defining and aligning biomarker hypotheses across trials, and the need to adapt sample sizes and trial designs. Nevertheless, we believe that a collaborative engagement of the academic, regulatory and pharmaceutical community can go a long way in addressing these issues and producing more-rapid results in the field of personalized medicine. In this Perspectives, we describe our views on the current fragmented approach to biomarker discovery and validation in relevant trials run within our own regions-that is, Europe, China, and the USA-and hope this article serves as a base for further reflection.
authors.affiliation: Molecular Digestive Oncology, University Hospitals Leuven and KU Leuven, Herestraat 49, 3000 Leuven, Belgium.
authors.forename: Sabine
authors.initials: S
authors.lastname: Tejpar
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital &Institute, 52 Fucheng Street, Beijing 100142, People's Republic of China.
authors.forename: Lin
authors.initials: L
authors.lastname: Shen
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital &Institute, 52 Fucheng Street, Beijing 100142, People's Republic of China.
authors.forename: Xicheng
authors.initials: X
authors.lastname: Wang
authors.affiliation: American Society of Clinical Oncology, 2318 Mill Road, Suite 800, Alexandria, VA 22314, USA.
authors.forename: Richard L
authors.initials: RL
authors.lastname: Schilsky
mesh_terms: D001208:Asia; D014408:Biomarkers, Tumor / Q000378:metabolism; D002986:Clinical Trials as Topic; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D005060:Europe; D006801:Humans; D007391:International Cooperation; D057285:Precision Medicine; D014481:United States
chemical_list: D014408:Biomarkers, Tumor