An Approach to the Validation of Markers for Use in AIDS Clinical Trials
作者： D. Mildvan , A. Landay , V. De Gruttola , S. G. Machado , J. Kagan
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摘要: Dr. Mildvan and coauthors have thoroughly reviewed documented what is known about the validation of surrogate markers for use in clinical trials. They proposed a classification system based on usefulness available immunologic virological assays as measures prognosis, drug activity, therapeutic efficacy. The latter, type II marker classification, should estimate proportion treatment effect explained by change induced therapy and, if complete, can substitute endpoints. HIV trialists had long-standing interest using surrogates endpoints to facilitate conduct experimental protocols decrease time effort required develop new strategies. approach outlined this review experienced clinicians, biostatisticians, immunologists provides framework evaluate currently potential markers.
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