In summary, the field of tumor marker generation is evolving rapidly, with a convergence of molecular biology and technology and understanding of clinical trial design and analysis. Several of the large cooperative trialists' groups have now established separate correlative/biologic committees that are charged with designing hypothesis-driven LOE I and II studies, based on results from pilot studies. The emergence of erbB-2 in breast cancer as a predictive factor, in a manner similar to ER, may serve as a model of directed studies that lead to determination of the relative strength of the marker and determination of whether it should be used clinically. One hopes that careful and thoughtful consideration of study design will considerably shorten the life cycle required to being a tumor marker from the laboratory to the clinic.

Acknowledgment. Supported in part by NIH grant CA64057 and by the Fashion Footwear Association of New York (FFANY)/QVC Presents/Shoes on Sale.

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