Wu Lang, Gilbert Peter B
Department of Statistics, University of British Columbia, Vancouver, British Columbia V6T 1Z2, Canada.
Biometrics. 2002 Dec;58(4):997-1004. doi: 10.1111/j.0006-341x.2002.00997.x.
At the present time, many AIDS clinical trials compare drug therapies by a time-to-event primary endpoint that measures the durability of suppression of HIV replication. For such studies, survival differences tend to occur early and/or late in the follow-up period due to drug differences in initial potency and/or durability of efficacy, and detecting these differences is of primary interest. We propose a weighted log-rank statistic that emphasizes early and/or late survival differences. We also consider some versatile tests that also emphasize these differences but are sensitive to a wider range of alternatives. The performances of the new tests are evaluated in numerical studies. For the alternatives of interest, the new tests show greater power and flexibility than commonly used weighted log-rank tests and related versatile tests. When the main interest is in detecting early and/or late survival differences, these tests may be preferable to the other versatile and weighted log-rank tests that have been studied.
目前,许多艾滋病临床试验通过一个事件发生时间的主要终点来比较药物疗法,该终点衡量的是HIV复制抑制的持久性。对于此类研究,由于初始效力和/或疗效持久性方面的药物差异,生存差异往往在随访期的早期和/或晚期出现,而检测这些差异是主要关注点。我们提出了一种加权对数秩统计量,它强调早期和/或晚期生存差异。我们还考虑了一些通用检验,这些检验也强调这些差异,但对更广泛的备择假设敏感。在数值研究中评估了新检验的性能。对于感兴趣的备择假设,新检验比常用的加权对数秩检验和相关通用检验具有更大的功效和灵活性。当主要关注点是检测早期和/或晚期生存差异时,这些检验可能比已研究的其他通用检验和加权对数秩检验更可取。