Other terms
- Biomarker-Driven Therapies
- Biosimilars
- BLA
- Blood-Brain Barrier (BBB)
- Branch Retinal Vein Occlusion (BRVO)
- Cancer Vaccines
- CAR T-Cell Therapy
- Cardiology
- Cardiomyopathy
- Case Report Form (CRF)
- Cataract
- Celiac Disease
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.
