Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.
University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC.
JCO Clin Cancer Inform. 2024 Apr;8:e2300183. doi: 10.1200/CCI.23.00183.
Mortality data can complement primary end points from cancer clinical trials. Yet, identifying deaths after trial completion is challenging, as timely and comprehensive vital status data are unavailable in the United States. We developed and evaluated a multisource approach to capture death data after clinical trial completion.
Individuals age 70 years and older with incurable solid tumors or lymphoma and ≥1 aging-related condition were enrolled from October 2014 to March 2019 (ClinicalTrials.gov identifier: NCT02107443 and NCT02054741). Participants provided consent to link trial information to external sources. We developed a stepped approach for extended death capture using (1) active trial follow-up up to 1 year, (2) linkage to the National Death Index (NDI), and (3) obituary searches, thus generating a 5-year survival curve. In a random sample of 50 participants who died during trial follow-up, we estimated sensitivity of death data using NDI and obituary sources and computed survival times by data source.
The two trials enrolled 1,169 participants; mean age was 76 years; 46% were female; and gastrointestinal cancer (30%) and lung cancer (26%) were the most common cancer types. Across data sources, maximum follow-up was >7 years; 5-year survival was 18%. In total, there were 841 deaths: 603 identified during trial follow-up; 199 from the NDI; and 39 from obituary searches. The sensitivity for death capture was 92% for the NDI and 94% for the obituary searches compared with the trial data, and computed survival times were similar across data sources.
Extending clinical trial mortality follow-up through linkage with external data sources was feasible and accurate. Future cancer clinical trials should collect necessary consent and patient identifiers for vital status linkages that can enhance understanding of longer-term outcomes.
死亡率数据可以补充癌症临床试验的主要终点。然而，在美国，由于缺乏及时和全面的生存状况数据，确定试验完成后的死亡情况具有挑战性。我们开发并评估了一种多源方法，以捕获临床试验完成后的死亡数据。
从 2014 年 10 月至 2019 年 3 月，共招募了年龄在 70 岁及以上、患有不可治愈的实体瘤或淋巴瘤且≥1 种与衰老相关疾病的患者（ClinicalTrials.gov 标识符：NCT02107443 和 NCT02054741）。参与者同意将试验信息与外部来源进行链接。我们开发了一种扩展死亡捕获的分步方法，包括（1）主动试验随访 1 年，（2）与国家死亡指数（NDI）链接，以及（3）讣告搜索，从而生成 5 年生存曲线。在试验随访期间死亡的 50 名随机参与者的样本中，我们使用 NDI 和讣告来源估计了死亡数据的敏感性，并按数据源计算了生存时间。
两项试验共纳入 1169 名参与者；平均年龄为 76 岁；46%为女性；最常见的癌症类型为胃肠道癌（30%）和肺癌（26%）。在所有数据源中，最长随访时间超过 7 年；5 年生存率为 18%。共有 841 人死亡：603 人在试验随访期间死亡；199 人来自 NDI；39 人来自讣告搜索。与试验数据相比，NDI 对死亡的捕获灵敏度为 92%，讣告搜索为 94%，计算的生存时间在不同数据源之间相似。
通过与外部数据源的链接扩展临床试验死亡率随访是可行且准确的。未来的癌症临床试验应收集必要的同意书和患者标识符，以便进行生存状况链接，从而增强对长期结局的理解。
