Surrogate End-Points or Primary Outcomes in Clinical Trials in Women with Polycystic Ovary Syndrome?

    June 2004 in “ Human Reproduction ”
    Richard S. Legro, Evan R. Myers
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    TLDR The document suggests that clinical trials for PCOS should focus on meaningful primary outcomes like live birth rates, rather than less reliable surrogate markers.
    The document from 2004 critiques the use of surrogate end-points in clinical trials for women with Polycystic Ovary Syndrome (PCOS), emphasizing the need for primary clinical outcomes that are meaningful to patients. It points out that surrogate markers like ovulation do not guarantee pregnancy due to other factors and that there is a lack of well-validated measures for hirsutism and cardiovascular disease risk in PCOS. The paper suggests that future research should focus on primary clinical endpoints, such as hirsutism and live birth rates, and that more studies are needed to validate surrogate markers. It also notes the evolution of PCOS from a disease to a syndrome and the consensus towards using unexplained hyperandrogenemic chronic anovulation as the central diagnostic criteria, with polycystic ovary morphology as a potential additional criterion.
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