III 期多中心 RTS，S/AS01 疟疾疫苗在非洲儿童中的疫苗效力评估的统计方法学。
Statistical methodology for the evaluation of vaccine efficacy in a phase III multi-centre trial of the RTS, S/AS01 malaria vaccine in African children.
机构信息
GlaxoSmithKline Biologicals, Wavre, Belgium.
出版信息
Malar J. 2011 Aug 4;10:222. doi: 10.1186/1475-2875-10-222.
Abstract
BACKGROUND
There has been much debate about the appropriate statistical methodology for the evaluation of malaria field studies and the challenges in interpreting data arising from these trials.
METHODS
The present paper describes, for a pivotal phase III efficacy of the RTS, S/AS01 malaria vaccine, the methods of the statistical analysis and the rationale for their selection. The methods used to estimate efficacy of the primary course of vaccination, and of a booster dose, in preventing clinical episodes of uncomplicated and severe malaria, and to determine the duration of protection, are described. The interpretation of various measures of efficacy in terms of the potential public health impact of the vaccine is discussed.
CONCLUSIONS
The methodology selected to analyse the clinical trial must be scientifically sound, acceptable to regulatory authorities and meaningful to those responsible for malaria control and public health policy.
摘要
背景
对于疟疾现场研究评估的适当统计方法以及这些试验产生的数据解释所面临的挑战，一直存在很多争议。
方法
本文描述了 RTS，S/AS01 疟疾疫苗关键性 III 期功效评估的统计分析方法及其选择原理。本文还介绍了用于评估初级疫苗接种疗程和加强剂量预防无并发症和严重疟疾临床发作的功效，以及确定保护持续时间的方法。本文还讨论了根据疫苗对公共卫生的潜在影响来解释各种功效衡量标准的问题。
结论
选择用于分析临床试验的方法学必须具有科学合理性，得到监管机构的认可，并对负责疟疾控制和公共卫生政策的人员有意义。
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