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肿瘤学临床试验中的患者报告结局：2019 年加速抗癌药物研发和验证研讨会的利益相关者观点。

Patient-Reported Outcomes in Oncology Clinical Trials: Stakeholder Perspectives from the Accelerating Anticancer Agent Development and Validation Workshop 2019.

机构信息

Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Quantitative Science, Clinical Outcomes Solutions, Tucson, Arizona, USA.

出版信息

Oncologist. 2020 Oct;25(10):819-821. doi: 10.1634/theoncologist.2020-0062. Epub 2020 Jun 9.

DOI:10.1634/theoncologist.2020-0062
PMID:32463153
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7543246/
Abstract

The measurement and analysis of patient‐reported outcomes is important in cancer clinical trials. This commentary reports advances and challenges from presentations at the 2019 Accelerating Anticancer Agent Development and Validation (AAADV) Workshop Patient‐Reported Outcomes Session.

摘要

患者报告结局的测量和分析在癌症临床试验中很重要。本篇述评报道了在 2019 年加速抗癌药物开发和验证（AAADV）研讨会患者报告结局会议上的演讲所取得的进展和面临的挑战。

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本文引用的文献

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Patient preferences of chemotherapy treatment options and tolerance of chemotherapy side effects in advanced stage lung cancer.晚期肺癌患者对化疗治疗方案的偏好和对化疗副作用的耐受性。
BMC Cancer. 2019 Aug 27;19(1):835. doi: 10.1186/s12885-019-6054-x.
2
Fit for purpose and modern validity theory in clinical outcomes assessment.适用于临床结局评估的目的和现代效度理论。
Qual Life Res. 2018 Jul;27(7):1711-1720. doi: 10.1007/s11136-017-1644-z. Epub 2017 Jul 7.
3
Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms.关注癌症临床试验中的核心患者报告结局：症状性不良事件、身体功能和疾病相关症状。
Clin Cancer Res. 2016 Apr 1;22(7):1553-8. doi: 10.1158/1078-0432.CCR-15-2035. Epub 2016 Jan 12.
4
Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.癌症药物研发和美国监管审查中的患者报告结局：来自工业界、美国食品和药物管理局以及患者的观点。
JAMA Oncol. 2015 Jun;1(3):375-9. doi: 10.1001/jamaoncol.2015.0530.
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Toward patient-centered drug development in oncology.迈向肿瘤学中以患者为中心的药物研发。
N Engl J Med. 2013 Aug 1;369(5):397-400. doi: 10.1056/NEJMp1114649. Epub 2013 Jul 3.