We created a database of reconstructed patient-level data from published clinical trials that includes multiple time-to-event outcomes such as overall survival and progression-free survival. Outcomes were extracted from Kaplan–Meier (KM) curves reported in 153 oncology Phase III clinical trial publications identified through a PubMed search of clinical trials in breast, lung, prostate and colorectal cancer, published between 2014 and 2016. For each trial that met our search criteria, we curated study-level information and digitized all reported KM curves with the software Digitizelt. We then used the digitized KM survival curves to estimate (possibly censored) patient-level time-to-event outcomes. Collections of time-to-event datasets from completed trials can be used to support the choice of appropriate trial designs for future clinical studies. Patient-level data allow investigators to tailor clinical trial designs to diseases and classes of treatments. Patient-level data also allow investigators to estimate the operating characteristics (e.g. power and type I error rate) of candidate statistical designs and methods. Database URL: https://10.6084/m9.figshare.14642247.v1

中文翻译：

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KMDATA：来自 153 项肿瘤临床试验的重建个体患者水平数据的精选数据库

我们从已发表的临床试验中创建了一个重建患者水平数据的数据库，其中包括多个事件发生时间结果，例如总生存期和无进展生存期。结果提取自 2014 年至 2016 年间发表的通过 PubMed 搜索乳腺癌、肺癌、前列腺癌和结直肠癌临床试验确定的 153 篇肿瘤学 III 期临床试验出版物中报告的 Kaplan-Meier (KM) 曲线。搜索标准，我们策划了研究级别的信息，并使用软件 Digitizelt 将所有报告的 KM 曲线数字化。然后，我们使用数字化的 KM 生存曲线来估计（可能经过审查）患者级别的事件发生时间结果。来自已完成试验的时间到事件数据集的集合可用于支持为未来的临床研究选择适当的试验设计。患者级别的数据使研究人员能够根据疾病和治疗类别定制临床试验设计。患者级别的数据还允许研究人员估计候选统计设计和方法的操作特征（例如功率和 I 类错误率）。数据库网址：https://10.6084/m9.figshare.14642247.v1