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Reflections and insights into the evolution of restrictive eligibility criteria for cancer clinical trials in China and beyond.

作者信息

Huang Huiyao, Miao Huilei, Tang Jinling, Li Ning

机构信息

Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.

Shenzhen Institute of Advanced Technology of the Chinese Academy of Sciences, Shenzhen, Guangdong, P. R. China.

出版信息

Cancer Commun (Lond). 2025 Jun;45(6):673-676. doi: 10.1002/cac2.70007. Epub 2025 Mar 12.

DOI:10.1002/cac2.70007
PMID:40077834
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12187573/
Abstract
摘要

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Thorac Cancer. 2024 May;15(14):1187-1194. doi: 10.1111/1759-7714.15269. Epub 2024 Apr 4.
2
Impact of Broadening Trial Eligibility Criteria on the Inclusion of Patients With Brain Metastases in Cancer Clinical Trials: Time Series Analyses for 2012-2022.拓宽试验纳入标准对癌症临床试验中纳入脑转移患者的影响:2012-2022 年的时间序列分析。
J Clin Oncol. 2024 Jun 1;42(16):1953-1960. doi: 10.1200/JCO.23.01777. Epub 2024 Mar 27.
3
Unfair older patients restriction in cancer drug trials in mainland China and corresponding solution.中国大陆癌症药物临床试验中对老年患者的不公平限制及相应解决方案。
BMC Geriatr. 2023 Mar 30;23(1):199. doi: 10.1186/s12877-023-03886-2.
4
Growth in eligibility criteria content and failure to accrue among National Cancer Institute (NCI)-affiliated clinical trials.资格标准内容的增长和国家癌症研究所(NCI)附属临床试验的累积失败。
Cancer Med. 2023 Feb;12(4):4715-4724. doi: 10.1002/cam4.5276. Epub 2022 Nov 18.
5
Evaluating eligibility criteria of oncology trials using real-world data and AI.利用真实世界数据和人工智能评估肿瘤学试验的入组标准。
Nature. 2021 Apr;592(7855):629-633. doi: 10.1038/s41586-021-03430-5. Epub 2021 Apr 7.
6
Eligibility in Cancer Clinical Research: The Intersection of Discovery, Generalizability, Beneficence, and Justice.癌症临床研究的资格:发现、可推广性、惠益和公正的交集。
Clin Cancer Res. 2021 May 1;27(9):2369-2371. doi: 10.1158/1078-0432.CCR-21-0085. Epub 2021 Feb 18.
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J Clin Oncol. 2020 Sep 20;38(27):3119-3128. doi: 10.1200/JCO.19.02104. Epub 2020 May 13.
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Re-Evaluating Eligibility Criteria for Oncology Clinical Trials: Analysis of Investigational New Drug Applications in 2015.重新评估肿瘤学临床试验的资格标准:2015年研究性新药申请分析
J Clin Oncol. 2017 Nov 20;35(33):3745-3752. doi: 10.1200/JCO.2017.73.4186. Epub 2017 Oct 2.
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J Thorac Oncol. 2017 Oct;12(10):1489-1495. doi: 10.1016/j.jtho.2017.07.020. Epub 2017 Aug 9.
10
External validity of randomised controlled trials: "to whom do the results of this trial apply?".随机对照试验的外部效度:“该试验结果适用于谁?”
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