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JNCI Journal of the National Cancer Institute 2006 98(8):502-503; doi:10.1093/jnci/djj153
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© The Author 2006. Published by Oxford University Press.

EDITORIAL

Surrogate Endpoints: Wishful Thinking or Reality?

Stuart G. Baker

Correspondence to: Stuart G. Baker, ScD, National Cancer Institute, EPN 3131, 6130 Executive Blvd., MSC 7354, Bethesda, MD 20892-7354 (e-mail: sb16i@nih.gov).

The first 150 words of the full text of this article appear below.

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.

However, before delving further it is necessary to precisely state the role of surrogate endpoints. The purpose of a surrogate endpoint is to draw conclusions about the effect of intervention on true endpoint without having to observe the true endpoint. . . . [Full Text of this Article]


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