Statistical aspect of translational and correlative studies in clinical trials

Chin Clin Oncol. 2016 Feb;5(1):11. doi: 10.3978/j.issn.2304-3865.2014.07.04.


In this article, we describe statistical issues related to the conduct of translational and correlative studies in cancer clinical trials. In the era of personalized medicine, proper biomarker discovery and validation is crucial for producing groundbreaking research. In order to carry out the framework outlined in this article, a team effort between oncologists and statisticians is the key for success.

Keywords: Big data; bioinformatics; biomarkers; oncology; personalized medicine; translational science.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Biomarkers, Tumor / analysis*
  • Clinical Trials as Topic / standards*
  • Clinical Trials as Topic / statistics & numerical data*
  • Humans
  • Multicenter Studies as Topic*
  • Neoplasms / therapy*
  • Prognosis
  • Research Design*
  • Translational Research, Biomedical*


  • Biomarkers, Tumor