Biomarker-Driven Randomization to Target Subjects

What is Biomarker-Driven Randomization to Target Subjects? Biomarker-driven randomization to target subjects is a clinical trial design that assigns patients to different treatment groups based on the presence or absence of specific biomarkers that may predict treatment response.

What Are The Benefits of Biomarker-Driven Randomization to Target Subjects?

  • Increases the likelihood of demonstrating treatment efficacy
  • Reduces the number of patients needed to demonstrate treatment efficacy
  • Maximizes the benefit-to-risk ratio of the treatment

 

What Are The Disadvantages of Biomarker-Driven Randomization to Target Subjects?

  • Limited generalizability
  • Increased complexity, cost, and time of trial
  • Increased risk of false positives
  • Limited availability and access for all patients

Source: Carrasco JL, Heng DY, Kapoor A. Biomarker-driven clinical trial design in oncology: past, present, and future. Curr Oncol Rep. 2020 Feb 17;22(3):23. doi: 10.1007/s11912-020-0896-2. PMID: 32067177.