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Commentary on “Surrogate Endpoints In Aids Drug Development: Current Status”, By Christy Chuang-Stein and Ralph Demasi

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Abstract

This paper offers commentary on “Surrogate Endpoints in AIDS Drug Development-Current Status” by Cristy Chuang-Stein and Ralph DeMasi which appears in this issue of the Drug Information Journal. Chuang-Stein and DeMasi pose the question: “Are researchers likely to be misled?” by surrogate endpoints, but the critical question is “How likely are researchers to be misled?” This commentary provides a brief review of AIDS treatments and knowledge. A reasonable strategy for assessing new HIV therapies might be to couple studies in pre-AIDS patients using viral load endpoints with studies in more advanced patients that can evaluate effects on clinical progression and mortality in a timely way. Researchers cannot answer the question “how likely” until they have seen marker and clinical data for a wide variety of products.

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Authors and Affiliations

  1. Division of Biostatistics and Epidemiology, Center for Biologies Evaluation and Research, Food and Drug Administration, FDA, 1401 Rockville Pike, HFM-210, Rockville, MD, 20852-1448, USA

    Susan S. Ellenberg PHD

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  1. Susan S. Ellenberg PHD
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This work reflects the opinion of the author and does not represent an official position of the FDA.

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Ellenberg, S.S. Commentary on “Surrogate Endpoints In Aids Drug Development: Current Status”, By Christy Chuang-Stein and Ralph Demasi. Ther Innov Regul Sci 32, 449–452 (1998). https://doi.org/10.1177/009286159803200216

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