Signal detection in real-world data and confirmation in clinical trials: Diabetes as a case study for a conversation worth having.
Signal detection in real-world data and confirmation in clinical trials: Diabetes as a case study for a conversation worth having.
复制标题
现实世界数据中的信号检测和临床试验中的确认：糖尿病作为值得讨论的案例研究。
DOI：
10.1002/cncr.34939
复制
发表时间：
2023
期刊：
影响因子：
6.2
通讯作者：
Quandt,ZoeEloise
中科院分区：
文献类型：
--
作者：
Sharon,Elad;Othus,Megan;Quandt,ZoeEloise
2017年，美国临床肿瘤学会、美国食品药品监督管理局和癌症研究之友发表了一系列关于扩大癌症临床试验资格标准的文章。[1]这些文章和之前的工作组的目标是使临床试验能够更准确地反映癌症患者的总体情况。美国国家癌症研究所（NCI）于2018年更新了其临床方案模板，以反映这一行动呼吁，并在2021年进一步努力继续这一过程，并针对其他领域进行优化，包括减少与洗脱期和性能状态相关的排除标准。与此同时，电子健康记录的快速数字化带来了真实世界数据（RWD）的革命，对患者数据进行了大量的行业和学术分析，从而可以更好地了解临床试验之外的患者结局。3-5在Leshem等人的文章中，研究人员使用两个独立的数据库来评估糖尿病对接受免疫检查点抑制剂治疗的非小细胞肺癌患者的预后的影响，无论是单独治疗还是与化疗联合治疗。研究人员发现，糖尿病患者与非糖尿病患者的生存结果存在差异。这一发现随后在更广泛的RWD数据集中得到证实。
In 2017, the American Society of Clinical Oncology, the US Food and Drug Administration, and Friends of Cancer Research published a series of articles on broadening eligibility criteria for cancer clinical trials. 1 The laudable goals of the articles and the preceding working groups were to enable clinical trials to more accurately reflect the population of cancer patients generally. The US National Cancer Institute (NCI) updated its clinical protocol templates to reflect this call to action in 2018, and further efforts in 2021 have continued the process with additional areas targeted for optimization, including reducing exclusion criteria related to washout periods and performance status. 2At the same time, a revolution in real-world data (RWD) has been emerging from the rapid digitization of electronic health records, with numerous industry and academic analyses of patient data, allowing for improved understanding of patient outcomes outside of clinical trials. 3–5 In the accompanying article by Leshem et al., 6 the investigators used two separate databases to evaluate the effect of diabetes on outcomes for patients with non–small cell lung cancer being treated with immune checkpoint inhibitors, either alone or in combination with chemotherapy. The investigators found a difference in survival outcomes when comparing diabetic patients to nondiabetic patients. This finding was then confirmed in a broader data set of RWD.