Figure 4
From: Generating and evaluating evidence of the clinical utility of molecular diagnostic tests in oncology
Designs having disadvantages. (a) Marker enrichment design. This is not recommended except where there exists compelling evidence that marker-negative patients cannot benefit from a treatment, or when a group of responders has been identified for further study within an otherwise highly heterogeneous population; no information on the excluded group is obtained. (b) Biomarker strategy design. This is not preferred because the approach reduces statistical power, given that patients in both study arms receive the “standard of care” as their intervention. MDx, molecular diagnostic. Adapted from ref. 40.
