首页> 外文期刊>The Journal of Infectious Diseases >Statistical interpretation of the RV144 HIV vaccine efficacy trial in Thailand: a case study for statistical issues in efficacy trials.
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Statistical interpretation of the RV144 HIV vaccine efficacy trial in Thailand: a case study for statistical issues in efficacy trials.

机译:泰国RV144 HIV疫苗功效试验的统计解释:功效试验中统计问题的案例研究。

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摘要

Recently, the RV144 randomized, double-blind, efficacy trial in Thailand reported that a prime-boost human immunodeficiency virus (HIV) vaccine regimen conferred approximately 30% protection against HIV acquisition. However, different analyses seemed to give conflicting results, and a heated debate ensued as scientists and the broader public struggled with their interpretation. The lack of accounting for statistical principles helped flame the debate, and we leverage these principles to provide a more scientific interpretation. We first address interpretation of frequentist results, including interpretation of P values, synthesis of results from multiple analyses (ie, intention-to-treat versus per-protocol/fully immunized), and accounting for external efficacy trials. Second, we address how Bayesian statistics, which provide clearly interpretable statements about probabilities that the vaccine efficacy takes certain values, provide more information for weighing the evidence about efficacy than do frequentist statistics alone. Third, we evaluate RV144 for completeness of end point ascertainment and integrity of blinding, necessary tasks for establishing robustly interpretable results.
机译:最近,在泰国进行的RV144随机,双盲,功效试验报告说,初免-加强型人免疫缺陷病毒(HIV)疫苗方案可提供约30%的保护,以防止感染HIV。但是,不同的分析似乎得出了相互矛盾的结果,随之而来的是激烈的辩论,因为科学家和广大公众都在为他们的解释而奋斗。缺乏统计原则的会计处理引发了争论,我们利用这些原则来提供更科学的解释。我们首先讨论对常客结果的解释,包括对P值的解释,多次分析结果的综合(即,意向性治疗与按方案/完全免疫的结果),以及考虑外部功效试验。其次,我们要解决的是贝叶斯统计如何提供有关疫苗功效具有特定价值的概率的清晰可解释的陈述,而不是仅仅依靠频繁性统计来提供更多信息来权衡有关功效的证据。第三,我们评估RV144的端点确定性和盲目性的完整性,这是建立可靠的可解释结果的必要任务。

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