On Statistical Methodology for Clinical Trials with Biomarker

Project: National Science and Technology CouncilNational Science and Technology Council Academic Grants

Project Details

Abstract

After completion of the Human Genome Project (HGP), the disease biomarker can be identified. As a result, treatment modality for predictive biomarker can be developed. However, the accuracy of diagnostic devices for identification of such predictive biomarker is usually not perfect. Therefore, the treatment effects of the targeted therapy estimated from predictive biomarker clinical trials could be biased. We will propose the method to incorporate the inaccuracy of the diagnostic variance for statistical inference of the predictive biomarker clinical trials under enrichment design and unselected design, with respect to the censored data. Hence, this research proposal will be devoted to develop the statistical methodology for evaluation two types of designs under weibull distribution model.

Project IDs

Project ID:PA10207-0408
External Project ID:NSC102-2118-M182-002
StatusFinished
Effective start/end date01/08/1331/07/14

Keywords

  • Predictive biomarker
  • Targeted therapy
  • Enrichment design
  • Unselected design
  • EM algorithm

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