Surrogate Endpoints: Wishful Thinking or Reality?

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Abstract
More than 100 years ago, the noted French mathematician Henri Poincaré quoted the following remark about the assumption of a normal distribution: “Everybody firmly believes in it because the mathematicians imagine it is a fact of observation, and observers that it is a theory of mathematics” ( 1 ) . A similar generalization could be made about methods to validate surrogate endpoints: Biostatisticians believe that the methods they propose are useful because clinicians adopt them, and clinicians believe that the methods proposed by biostatisticians are useful because they have the “imprimatur” of mathematical statistics. Given this state of affairs, a critical examination of methods to validate surrogate endpoints is needed.