doi: 10.5732/cjc.012.10248

New evidence-based adaptive clinical trial methods for optimally integrating predictive biomarkers into oncology clinical development programs

Robert A. Beckman, Cong Chen

Oncology Clinical Research, Daiichi Sankyo Pharmaceutical Development, Edison, New Jersey 08837, USA

[Abstract] Predictive biomarkers are important to the future of oncology; they can be used to identify patient populations who will benefit from therapy, increase the value of cancer medicines, and decrease the size and cost of clinical trials while increasing their chance of success. But predictive biomarkers do not always work. When unsuccessful, they add cost, complexity, and time to drug development. This perspective describes phases 2 and 3 development methods that efficiently and adaptively check the ability of a biomarker to predict clinical outcomes. In the end, the biomarker is emphasized to the extent that it can actually predict.

Chinese Journal of Cancer 2013, Volume: 32, Issue 5, Page: 233-241

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Robert A. Beckman, Cong Chen. New evidence-based adaptive clinical trial methods for optimally integrating predictive biomarkers into oncology clinical development programs. Chin J Cancer. 2013, 32(5):233-241. doi:10.5732/cjc.012.10248


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