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对口服抗癌疗法的患者报告结果数据的可用性
Britny R Brown1, Jessica Samuel1,2, Morgan Teeters3
1University of Rhode Island College of Pharmacy, Kingston, RI.
JCO oncology practice
|November 21, 2025
概括
大多数口服抗癌疗法收集患者报告的结果 (PRO),但在批准时报告率仍然低于最佳水平. 需要进一步的研究,以改善癌症治疗的PRO数据的及时可用性.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 健康 结果 研究 研究 结果
背景情况:
- 美国食品和药物管理局 (FDA) 在2016年发布了有关患者报告结果 (PRO) 的指南,旨在将其纳入临床试验.
- 尽管取得了进展,但在FDA批准时,许多口服抗癌疗法的PRO数据尚未报告.
- 需要加强口服抗癌疗法PRO数据的收集和报告.
研究的目的:
- 量化2018年1月至2023年8月期间FDA批准的口服抗癌疗法PRO数据的可用性率.
- 确定影响PRO数据在口服抗癌疗法的临床试验中报告的因素.
主要方法:
- 美国FDA批准的口服抗癌疗法的回顾性,横截面审查.
- 从2018年1月到2023年8月收集的数据.
- 使用SPSS版本29进行的描述性数据分析和统计测试.
主要成果:
- 75%的FDA批准包括PRO数据收集,每次批准中位数为3个PRO.
- 报告了收集的PRO的69.7%.
- 作为次要目标收集的PRO更有可能被报告 (80.1%),而不是作为探索性目标 (52.6%).
- 癌症治疗功能评估 (FACT) 调查显示报告率最高 (95.2%).
- 随后的PRO出版物与最初的出版物 (158.6) 相比,具有较低的中位影响因子 (7.1).
结论:
- 大多数口服抗癌疗法试验收集PRO,表明数据收集的进展.
- 有机会在药物批准时增加PRO数据的可用性.
- 需要进一步的研究,以了解和优化影响及时PRO数据报告的因素.
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