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Integrating biomarkers in colorectal cancer trials in the West and China

Nature Reviews Clinical Oncology volume 12, pages 553–560 (2015)Cite this article

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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.

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Figure 1: Current and future scenarios for registration and market-approval trials.

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Change history

  • 28 May 2015

    In the online version of this article, Lin Shen was incorrectly spelt Li Shen. This error has now been corrected for the HTML and PDF versions of the article published online.

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Author information

Authors and Affiliations

  1. Molecular Digestive Oncology, University Hospitals Leuven and KU Leuven, Herestraat 49, Leuven, 3000, Belgium

    Sabine Tejpar

  2. Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, 52 Fucheng Street, Beijing, 100142, People's Republic of China

    Lin Shen & Xicheng Wang

  3. American Society of Clinical Oncology, 2318 Mill Road, Suite 800, Alexandria, 22314, VA, USA

    Richard L. Schilsky

Authors
  1. Sabine Tejpar
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  2. Lin Shen
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  4. Richard L. Schilsky
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All authors researched the data for the article, contributed substantially to discussion of content, wrote the article, and reviewed and edited the manuscript before submission.

Corresponding authors

Correspondence to Sabine Tejpar or Lin Shen.

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Competing interests

S.T. has received research funding from Bayer and Sanofi. The other authors declare no competing interests.

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Tejpar, S., Shen, L., Wang, X. et al. Integrating biomarkers in colorectal cancer trials in the West and China. Nat Rev Clin Oncol 12, 553–560 (2015). https://doi.org/10.1038/nrclinonc.2015.88

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