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利用患者报告的结局指标进行癌症早期试验的最佳剂量选择。

Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials.

作者信息

Byrom Bill, Everhart Anthony, Cordero Paul, Garratt Chris, Meyer Tim

机构信息

Science and Medicine, Signant Health, 785 Arbor Way, Blue Bell, PA, 19422, United States, 44 20 4526 1340.

Patient Informed Development & Health Value Translation, Sanofi Pharmaceuticals, Reading, United Kingdom.

出版信息

JMIR Cancer. 2025 Feb 28;11:e64611. doi: 10.2196/64611.

DOI:10.2196/64611
PMID:40020239
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11888580/
Abstract

While patient-reported outcome measures are regularly incorporated into phase 3 clinical trials, they have been infrequently used in early phase trials. However, the patient's perspective is vital to fully understanding dose toxicity and selecting an optimal dose. This viewpoint paper reviews the rationale for and practical approach to collecting patient-reported outcome data in early phase oncology drug development and the rationale for electronic collection.

摘要

虽然患者报告的结局指标经常被纳入3期临床试验，但在早期试验中却很少使用。然而，患者的观点对于全面理解剂量毒性和选择最佳剂量至关重要。这篇观点文章回顾了在肿瘤学药物早期开发中收集患者报告结局数据的基本原理和实际方法，以及电子收集的基本原理。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f8e/11888580/d1b3de3db176/cancer-v11-e64611-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f8e/11888580/4effdfda6405/cancer-v11-e64611-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f8e/11888580/3a8b18e4c8c7/cancer-v11-e64611-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f8e/11888580/6b9d55dfeb71/cancer-v11-e64611-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f8e/11888580/d1b3de3db176/cancer-v11-e64611-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f8e/11888580/4effdfda6405/cancer-v11-e64611-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f8e/11888580/3a8b18e4c8c7/cancer-v11-e64611-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f8e/11888580/6b9d55dfeb71/cancer-v11-e64611-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f8e/11888580/d1b3de3db176/cancer-v11-e64611-g004.jpg

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本文引用的文献

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A tailored phase I-specific patient-reported outcome (PRO) survey to capture the patient experience of symptomatic adverse events.定制的 I 期特定患者报告结局（PRO）调查，以捕捉症状性不良事件的患者体验。
Br J Cancer. 2023 Sep;129(4):612-619. doi: 10.1038/s41416-023-02307-w. Epub 2023 Jul 7.
2
Project Optimus, an FDA initiative: Considerations for cancer drug development internationally, from an academic perspective.“擎天柱计划”，一项美国食品药品监督管理局的倡议：从学术角度看国际癌症药物研发的考量因素
Front Oncol. 2023 Mar 3;13:1144056. doi: 10.3389/fonc.2023.1144056. eCollection 2023.
3
Using Patient-Reported Outcomes in Dose-Finding Oncology Trials: Surveys of Key Stakeholders and the National Cancer Research Institute Consumer Forum.
在肿瘤学剂量发现试验中使用患者报告结局：关键利益相关者和国家癌症研究所消费者论坛的调查。
Oncologist. 2022 Sep 2;27(9):768-777. doi: 10.1093/oncolo/oyac117.
4
Evaluating the clinical utility of the patient-identified most bothersome symptom measure from PROMISE-2 for research in migraine prevention.评估 PROMISE-2 中患者确定的最困扰症状测量指标在偏头痛预防研究中的临床效用。
Headache. 2022 Jun;62(6):690-699. doi: 10.1111/head.14295. Epub 2022 Apr 25.
5
Difference in Estimation of Side Effects of Chemotherapy between Physicians and Patients with Early-Stage Breast Cancer: The Use of Patient Reported Outcomes (PROs) in the Evaluation of Toxicity in Everyday Clinical Practice.早期乳腺癌患者与医生对化疗副作用估计的差异：在日常临床实践中使用患者报告结局（PROs）评估毒性
Cancers (Basel). 2021 Nov 25;13(23):5922. doi: 10.3390/cancers13235922.
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The Use of Patient-Reported Outcome Measures in Phase I Oncology Clinical Trials.在肿瘤 I 期临床试验中使用患者报告结局测量。
Oncology. 2021;99(7):444-453. doi: 10.1159/000514874. Epub 2021 Apr 6.
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