Simes R J, Zelen M
J Clin Oncol. 1985 Oct;3(10):1418-31. doi: 10.1200/JCO.1985.3.10.1418.
This report discusses how one can use the hazard function to gain important insights on the patterns of failure in clinical studies when the principal endpoint is a time metric. These new insights may help gain increased understanding into the pathogenesis of a chronic disease and how it is affected by treatment intervention. The qualitative behavior of the hazard function can reveal whether mortality is increasing, decreasing, or is constant over time. Simple graphic plots are all that is necessary to show characteristic failure patterns. These informal procedures are in the spirit of carrying out exploratory analyses on the data. This report discusses the organization of clinical data using a "branch and leaf" plot, outlines the calculation of the hazard function and life table, and uses examples from lung cancer and uveal melanoma to illustrate calculations and ways of interpreting hazard functions.
本报告讨论了在主要终点为时间指标时，如何利用风险函数来深入了解临床研究中的失败模式。这些新的见解可能有助于增进对慢性病发病机制及其如何受治疗干预影响的理解。风险函数的定性行为可以揭示死亡率随时间是增加、减少还是保持不变。简单的图形绘制就足以展示特征性的失败模式。这些非正式程序符合对数据进行探索性分析的精神。本报告讨论了使用“枝叶”图来组织临床数据，概述了风险函数和生命表的计算，并以肺癌和葡萄膜黑色素瘤为例来说明计算方法和解释风险函数的方式。
