Can molecular biomarker-based patient selection in Phase I trials accelerate anticancer drug development?

Craig P. Carden, Debashis Sarker, Sophie Postel-Vinay, Timothy A. Yap, Gerthardt Attard, Udai Banerji, Michelle D. Garrett, George V. Thomas, Paul Workman, Stan B. Kaye, Johann S. de Bono

Research output: Contribution to journalReview articlepeer-review

58 Citations (Scopus)

Abstract

Anticancer drug development remains slow, costly and inefficient. One way of addressing this might be the use of predictive biomarkers to select patients for Phase I/II trials. Such biomarkers, which predict response to molecular-targeted agents, have the potential to enrich these trials with patients more likely to benefit. Doing so could maximize the efficiency of anticancer drug development by facilitating earlier clinical qualification of predictive biomarkers and generating valuable information on cancer biology. In this review, we suggest a new model of early clinical trial design, which incorporates patient selection through predictive molecular biomarkers for selected targeted agents.

Original languageEnglish
Pages (from-to)88-97
Number of pages10
JournalDrug Discovery Today
Volume15
Issue number3-4
DOIs
Publication statusPublished - 1 Feb 2010
Externally publishedYes

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