Pharmacogenetics- and pharmacogenomics-based rational clinical trial designs in oncology

Rui Qin, Manish Kohli

Research output: Contribution to journalReview articlepeer-review

2 Scopus citations


The rapid evolution of molecular technologies that can identify genetic markers and lead to dissecting the inherent variance of individual cancer biology has had a tangible impact on trial designs in oncology. Rational trial designs based on molecular marker expression coupled with drug-marker interactions have started to be adopted, challenging the previous paradigms of morphology-based, single-arm efficacy studies. This review summarizes novel trials being developed based on molecular predictive factor therapeutics and the potential impact these novel trial designs will have on the practice of oncology in future. A variety of clinical trial designs based on tumor and drug-host genetic interactions are discussed and the example of advanced prostate cancer is used to illustrate the changing landscape of clinical trial designs in cancer.

Original languageEnglish (US)
Pages (from-to)859-869
Number of pages11
JournalPersonalized Medicine
Issue number8
StatePublished - Nov 1 2013


  • adaptive clinical trial
  • genomic signature
  • molecular profiling
  • pharmacogenetic
  • predictive biomarker

ASJC Scopus subject areas

  • Molecular Medicine
  • Pharmacology


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