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肿瘤学临床试验的演进:使用创新研究设计定义谁能从新药中获益。

The Evolution of Clinical Trials in Oncology: Defining Who Benefits from New Drugs Using Innovative Study Designs.

机构信息

Department of Medicine, Morgantown, West Virginia, USA

West Virginia University Cancer Institute, Morgantown, West Virginia, USA.

出版信息

Oncologist. 2017 Sep;22(9):1015-1019. doi: 10.1634/theoncologist.2017-0153. Epub 2017 Jun 15.

DOI:10.1634/theoncologist.2017-0153
PMID:28620092
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5599203/
Abstract

Historically, advocates of randomized drug treatment trials in oncology contributed to the changing paradigm for testing cancer treatments in the U.S., which led to global efforts to generate evidence of promise in preclinical model systems and translate those findings into improved patient outcomes. In the age of genomic medicine, the challenge to speed the evolution of how clinical trials are conducted in patients with cancer continues.

摘要

从历史上看,肿瘤学中随机药物治疗试验的倡导者推动了美国癌症治疗试验范式的改变,这促使全球努力在临床前模型系统中产生有希望的证据,并将这些发现转化为改善患者的治疗结果。在基因组医学时代,加快癌症患者临床试验开展方式演变的挑战仍在继续。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/5599203/bf9fe755a060/onco12196-fig-0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/5599203/bf9fe755a060/onco12196-fig-0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a27/5599203/bf9fe755a060/onco12196-fig-0001.jpg

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本文引用的文献

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Clin Pharmacol Ther. 2016 Dec;100(6):699-712. doi: 10.1002/cpt.515. Epub 2016 Oct 19.
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Adaptive Randomization of Veliparib-Carboplatin Treatment in Breast Cancer.维利帕尼-卡铂治疗乳腺癌的适应性随机分组
N Engl J Med. 2016 Jul 7;375(1):23-34. doi: 10.1056/NEJMoa1513749.
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Mining the ACCENT database: a review and update.挖掘ACCENT数据库:综述与更新
临床试验是否满足当前的护理需求?西班牙加利西亚地区消化肿瘤专家运用德尔菲法的观点。
Healthcare (Basel). 2021 Jun 3;9(6):665. doi: 10.3390/healthcare9060665.
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Evaluating a Video-Based, Personalized Webpage in Genitourinary Oncology Clinical Trials: A Phase 2 Randomized Trial.评估基于视频的个性化网页在泌尿生殖系统肿瘤临床试验中的应用:一项2期随机试验。
J Med Internet Res. 2019 May 2;21(5):e12044. doi: 10.2196/12044.
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Clinical Trials in Oncology and Defining Benefit.肿瘤学临床试验与获益定义。
Oncologist. 2018 Jan;23(1):135. doi: 10.1634/theoncologist.2017-0476. Epub 2017 Nov 13.
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The role of nonrandomized trials in the evaluation of oncology drugs.非随机临床试验在肿瘤药物评价中的作用。
Clin Pharmacol Ther. 2015 May;97(5):502-7. doi: 10.1002/cpt.86. Epub 2015 Apr 7.
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Commensurate Priors for Incorporating Historical Information in Clinical Trials Using General and Generalized Linear Models.使用广义线性模型和广义线性模型在临床试验中纳入历史信息的相称先验。
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The ARCAD clinical trials program: an update and invitation.ARCAD 临床试验项目:更新与邀请
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