The Use of Patient-Reported Outcome Measures in Phase I Oncology Clinical Trials
The Use of Patient-Reported Outcome Measures in Phase I Oncology Clinical Trials
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DOI：
10.1159/000514874
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发表时间：
2021-04-06
期刊：
影响因子：
3.5
通讯作者：
Ganti, Apar Kishor
中科院分区：
文献类型：
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作者：
Coleman, Robert L.;Beck, J. Thaddeus;Ganti, Apar Kishor
目的：调查I期肿瘤临床试验中患者报告结果(PRO)的使用情况，包括PRO措施的类型和随时间的变化。方法：我们分析了截至2019年12月完成的I期肿瘤临床试验的ClinicalTrials.gov记录。结果：在所有符合条件的试验中，2.3%(129/5,515)报告的>；=1 PRO，总计181次PRO用法。随着时间的推移，PRO的使用率从0.6%(2000年之前开始的试验)增加到3.4%(2015年至2019年开始的试验)。最常见的预防措施是未指明的(29%)、肿瘤特异性的(24%)和普通癌症(19%)。结论：虽然PRO在I期肿瘤临床试验中并不常见，但随着时间的推移，PRO的使用量正在增加。在ClinicalTrials.gov上，预防措施往往没有具体说明，这表明需要更准确的报告和标准化。
Objective: To investigate patient-reported outcome (PRO) usage in phase I oncology clinical trials, including types of PRO measures and changes over time. Methods: We analyzed ClinicalTrials.gov records of phase I oncology clinical trials completed by December 2019. Results: Of all eligible trials, 2.3% (129/5,515) reported >= 1 PRO, totaling 181 instances of PRO usage. PRO usage increased over time, from 0.6% (trials initiated before 2000) to 3.4% (trials starting between 2015 and 2019). The most common PRO measures were unspecified (29%), tumor-specific (24%), and generic cancer (19%). Conclusion: Although uncommon in phase I oncology clinical trials, PRO usage is increasing over time. PRO measures were often unspecified on ClinicalTrials.gov, suggesting that more precise reporting and standardization are needed.