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. Author manuscript; available in PMC: 2009 Feb 1.
Published in final edited form as: J Stat Plan Inference. 2008 Feb 1;138(2):308–320. doi: 10.1016/j.jspi.2007.06.010

Figure 3.

Figure 3

Targeted clinical trial design for evaluating a new experimental therapy. A biomarker classifier is developed for identifying those patients most likely to respond to the new treatment (E). Only those patients are randomized to E versus the control treatment. The patients predicted less likely to respond (marker negative) are off study. The targeted design is most useful in cases where the biomarker classifier has a strong biological rationale for identifying responsive patients and where it may not be ethically advisable to expose marker negative patients to the new treatment.