Optimal design of trials to demonstrate the utility ofgenomically-guided therapy: Putting Precision CancerMedicine to the test

Rodrigo Dienstmann, Jordi Rodon, Josep Tabernero

Research output: Contribution to journalReview articleResearchpeer-review

20 Citations (Scopus)

Abstract

© 2014 Federation of European Biochemical Societies. The new age of Precision Cancer Medicine, with specific biomarkers being used to direct targeted agents, generally concerns only a subset of patients within a certain histopathologically defined tumor type. This paradigm is challenged by the need to perform widespread molecular screening in certified laboratories, with results available to clinicians within reasonable timeframe. Tumor heterogeneity and clonal evolution must be considered in the decision making process. Adaptive and innovative clinical trial designs exploring predictive algorithms and reconsideration of traditional efficacy endpoints are required to rapidly translate scientific discoveries into patient care. Furthermore, international collaboration in cancer research and open discussions on the availability of investigational agents will likely redefine the drug development and approval process in the coming years.
Original languageEnglish
Pages (from-to)940-950
JournalMolecular Oncology
Volume9
Issue number5
DOIs
Publication statusPublished - 1 May 2015

Keywords

  • Clinical trial design
  • Precision Cancer Medicine
  • Targeted therapy

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