Finkelstein D M, Schoenfeld D A
Biostatistics Department, Harvard School of Public Health, Boston, MA 02115, USA.
Stat Med. 1999 Jun 15;18(11):1341-54. doi: 10.1002/(sici)1097-0258(19990615)18:11<1341::aid-sim129>3.0.co;2-7.
Clinical trials often assess therapeutic benefit on the basis of an event such as death or the diagnosis of disease. Usually, there are several additional longitudinal measures of clinical status which are collected to be used in the treatment comparison. This paper proposes a simple non-parametric test which combines a time to event measure and a longitudinal measure so that a substantial treatment difference on either of the measures will reject the null hypothesis. The test is applied on AIDS prophylaxis and paediatric trials.
临床试验通常基于诸如死亡或疾病诊断等事件来评估治疗效果。通常,还会收集若干额外的临床状态纵向测量指标,用于治疗比较。本文提出了一种简单的非参数检验方法,该方法将事件发生时间测量指标和纵向测量指标相结合,这样,任一测量指标上的显著治疗差异都会拒绝原假设。该检验方法应用于艾滋病预防试验和儿科试验。