Drug-Diagnostic Co-Development: Statistical Issues for Companion Diagnostic
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*Lakshmi Vishnuvajjala, U.S. Food and Drug Administration 

Keywords: Co-Development, Companion Diagnostic, Study Design

With the increase in the number of drugs that are used in conjunction with a diagnostic test, the study designs for co-development are extremely important. Issues for study design are sometimes complicated by the fact that the drugs and diagnostics are developed by different sponsors and a design that can demonstrate that the drug is efficacious cannot necessarily show that the diagnostic is effective.