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Ethics and Clinical Research: Improving Transparency and Informed Consent in Phase I Oncology Trials.

作者信息

Frankel Paul H, Groshen Susan, Beumer Jan H, Cleveland Laura, Kim Edward S, Karp Judith E

机构信息

Department of Computational and Quantitative Medicine, City of Hope, Duarte, CA.

Department of Preventive Medicine, University of Southern California, Los Angeles, CA.

出版信息

J Clin Oncol. 2023 Apr 20;41(12):2155-2158. doi: 10.1200/JCO.22.01736. Epub 2023 Feb 1.

DOI:10.1200/JCO.22.01736
PMID:36724409
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10448934/
Abstract
摘要

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The Drug-Dosing Conundrum in Oncology - When Less Is More.肿瘤学中的给药难题——少即是多。
N Engl J Med. 2021 Oct 14;385(16):1445-1447. doi: 10.1056/NEJMp2109826. Epub 2021 Oct 9.
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Untenable dosing: A common pitfall of modern DLT-targeting Phase I designs in oncology.不可持续的剂量：肿瘤学中现代 DLT 靶向 I 期设计的常见陷阱。
Curr Probl Cancer. 2020 Dec;44(6):100583. doi: 10.1016/j.currproblcancer.2020.100583. Epub 2020 May 7.
3
Model of a Queuing Approach for Patient Accrual in Phase 1 Oncology Studies.用于 1 期肿瘤学研究患者入组的排队方法模型。
JAMA Netw Open. 2020 May 1;3(5):e204787. doi: 10.1001/jamanetworkopen.2020.4787.
4
Phase I trials as valid therapeutic options for patients with cancer.I 期临床试验是癌症患者有效的治疗选择。
Nat Rev Clin Oncol. 2019 Dec;16(12):773-778. doi: 10.1038/s41571-019-0262-9. Epub 2019 Sep 2.
5
Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource.遵守在欧盟临床试验注册库中报告结果的要求：队列研究与网络资源
BMJ. 2018 Sep 12;362:k3218. doi: 10.1136/bmj.k3218.
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Do Patients With Advanced Cancer Have the Ability to Make Informed Decisions for Participation in Phase I Clinical Trials?晚期癌症患者是否有能力参与 I 期临床试验做出知情决策？
J Clin Oncol. 2018 Aug 20;36(24):2483-2491. doi: 10.1200/JCO.2017.73.3592. Epub 2018 Jul 9.
7
Adaptive dose-finding studies: a review of model-guided phase I clinical trials.适应性剂量探索研究：模型引导的I期临床试验综述
J Clin Oncol. 2014 Aug 10;32(23):2505-11. doi: 10.1200/JCO.2013.54.6051. Epub 2014 Jun 30.
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A modified toxicity probability interval method for dose-finding trials.改良毒性概率区间法在探索性剂量试验中的应用。
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