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Statistical challenges in the evaluation of surrogate endpoints in randomized trials.

机译：在随机试验中评估替代终点的统计挑战。

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摘要

The validation of surrogate endpoints has been studied by Prentice, who presented a definition as well as a set of criteria that are equivalent if the surrogate and true endpoints are binary. Freedman et al. supplemented these criteria with the so-called proportion explained. Buyse and Molenberghs proposed to replace the proportion explained by two quantities: (1) the relative effect, linking the effect of treatment on both endpoints, and (2) the adjusted association, an individual-level measure of agreement between both endpoints. In a multiunit setting, these quantities can be generalized to a trial-level measure of surrogacy and an individual-level measure of surrogacy. In this paper, we argue that such a multiunit approach should be adopted because it overcomes difficulties that necessarily surround validation efforts based on a single trial. These difficulties are highlighted.
机译：代理端点的验证已由Prentice研究，他提出了定义和一组标准（如果代理端点和真实端点是二进制的，则等价）。 Freedman等。通过解释的所谓比例对这些标准进行了补充。 Buyse和Molenberghs建议用两个数量代替解释的比例：（1）相对效果，将治疗对两个端点的影响联系在一起;（2）调整后的关联，这是两个端点之间协议的个体水平度量。在多单元环境中，这些数量可以概括为代孕的试验水平和代孕的个体水平。在本文中，我们认为应该采用这种多单元方法，因为它克服了围绕单个试验进行验证工作所必然遇到的困难。这些困难突出。

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