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A Roadmap for the Development of Targeted Therapeutics in the
New Paradigms for Clinical Drug Development in the Genomic Era Richard Simon, D.Sc. Chief, Biometric Research Branch National Cancer Institute /brb “Biomarkers” Surrogate endpoints A measurement made on a patient before, during and after treatment to determine whether the treatment is working Predictive classifier A measurement made before treatment to predict whether a particular treatment is likely to be beneficial Surrogate Endpoints It is extremely difficult to properly validate a biomarker as a surrogate for clinical outcome. It requires a series of randomized trials with both the candidate biomarker and clinical outcome measured Biomarkers for use in phase I/II studies need not be validated as surrogates for clinical outcome Surrogate Endpoints Intermediate endpoints are useful for phase I and phase II studies. They don’t need to be “validated” surrogates for this purpose It is often more difficult to properly “validate” an endpoint as a surrogate than to use the clinical endpoint in phase III trials Validity of a Surrogate Endpoint Prentice RL. Surrogate endpoints in clinical trials: Definition and operational criteria. Statistics in Medicine 8:431-40, 1989. Test of the null hypothesis of no effect on surrogate outcome S between treatment and control is a valid test of the null hypothesis of no effect on true outcome T between treatment and control. i S fully captures the effect of treatment on T ii S is informative about T “One rarely can establish that surrogate endpoints are valid. Even in that rare setting in which data on treatment Z would allow one to view S as a valid surrogate for T, one cannot extrapolate this surrogacy to any new treatment Z* that could have mechanisms of action that differ from those of Z.” Fleming TR, Statistical Science 7:428-56, 1992 Partial Surrogate Endpoint Improvement of a partial surrogate endpoint is a necessary but not sufficient condition for improvement of the clinical endpoint When to hold and when to fold
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