• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

去中心化临床试验在癌症药物研发中的作用:肿瘤学家和患者调查结果

Role of decentralized clinical trials in cancer drug development: Results from a survey of oncologists and patients.

作者信息

de Las Heras Begoña, Daehnke Adam, Saini Kamal S, Harris Melissa, Morrison Kenneth, Aguilo Ariel, Chico Isagani, Vidal Laura, Marcus Robin

机构信息

Labcorp Drug Development Inc., Burlington, North Carolina, USA.

Madrid Medical Doctors Association, Spain.

出版信息

Digit Health. 2022 May 25;8:20552076221099997. doi: 10.1177/20552076221099997. eCollection 2022 Jan-Dec.

DOI:10.1177/20552076221099997
PMID:35646380
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9136463/
Abstract

As a result of the unprecedented challenges imposed by the COVID-19 pandemic on enrollment to cancer clinical trials, there has been an urgency to identify and incorporate new solutions to mitigate these difficulties. The concept of decentralized or hybrid clinical trials has rapidly gained currency, given that it aims to reduce patient burden, increase patient enrollment and retention, and preserve quality of life, while also increasing the efficiency of trial logistics. Therefore, the clinical trial environment is moving toward remote collection and assessment of data, transitioning from the classic site-centric model to one that is more patient-centric.

摘要

由于新冠疫情给癌症临床试验的入组带来了前所未有的挑战,因此迫切需要识别并采用新的解决方案来缓解这些困难。去中心化或混合型临床试验的概念迅速流行起来,因为它旨在减轻患者负担、增加患者入组和留存率、保持生活质量,同时还能提高试验后勤效率。因此,临床试验环境正在朝着远程数据收集和评估发展,从传统的以研究点为中心的模式转变为更以患者为中心的模式。

相似文献

1
Role of decentralized clinical trials in cancer drug development: Results from a survey of oncologists and patients.去中心化临床试验在癌症药物研发中的作用:肿瘤学家和患者调查结果
Digit Health. 2022 May 25;8:20552076221099997. doi: 10.1177/20552076221099997. eCollection 2022 Jan-Dec.
2
Remote Monitoring and Data Collection for Decentralized Clinical Trials.去中心化临床试验的远程监测和数据收集。
JAMA Netw Open. 2024 Apr 1;7(4):e246228. doi: 10.1001/jamanetworkopen.2024.6228.
3
From a decentralized clinical trial to a decentralized and clinical-trial-in-a-box platform: Towards patient-centric and equitable trials.从分散式临床试验到分散式一体化临床试验平台:迈向以患者为中心的公平试验。
J Clin Transl Sci. 2023 Oct 9;7(1):e236. doi: 10.1017/cts.2023.629. eCollection 2023.
4
The impact of COVID-19 on cancer care and oncology clinical research: an experts' perspective.COVID-19 对癌症护理和肿瘤临床研究的影响:专家观点。
ESMO Open. 2022 Feb;7(1):100339. doi: 10.1016/j.esmoop.2021.100339. Epub 2021 Nov 23.
5
Ethical Considerations in Decentralized Clinical Trials.去中心化临床试验中的伦理考量。
J Bioeth Inq. 2023 Dec;20(4):711-718. doi: 10.1007/s11673-024-10341-3. Epub 2024 Mar 1.
6
Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.试验创新网络中的去中心化临床试验:价值、策略及经验教训
J Clin Transl Sci. 2023 Jul 25;7(1):e170. doi: 10.1017/cts.2023.597. eCollection 2023.
7
The Patient Motivation Pyramid and Patient-Centricity in Early Clinical Development.患者激励金字塔与早期临床开发中的以患者为中心
Curr Rev Clin Exp Pharmacol. 2022;17(1):8-17. doi: 10.2174/1574884716666210427115820.
8
Decentralized Clinical Trials in Early Drug Development-A Framework Proposal.早期药物研发中的去中心化临床试验——一项框架提案
J Immunother Precis Oncol. 2024 Aug 19;7(3):190-200. doi: 10.36401/JIPO-23-33. eCollection 2024 Aug.
9
Exploring the divergence in perspectives on clinical trial operations in South Korea during the COVID-19 pandemic: a comparison of a trial site and sponsors.探索新冠疫情期间韩国临床试验运营视角的差异:试验场所与申办方的比较
Front Med (Lausanne). 2024 Mar 6;11:1342184. doi: 10.3389/fmed.2024.1342184. eCollection 2024.
10
Quantifying Site Burden to Optimize Protocol Performance.量化研究部位负担以优化方案性能。
Ther Innov Regul Sci. 2024 Mar;58(2):347-356. doi: 10.1007/s43441-023-00602-5. Epub 2024 Jan 8.

引用本文的文献

1
Adaptation of Clinical Research Staff to Decentralized Clinical Trials and Impacts on the Patient-Centered Experience: Qualitative Interview Study.临床研究人员对去中心化临床试验的适应及其对以患者为中心体验的影响:定性访谈研究
J Med Internet Res. 2025 Jun 16;27:e62947. doi: 10.2196/62947.
2
Sample-size determination for decentralized clinical trials.去中心化临床试验的样本量确定
Int J Epidemiol. 2025 Apr 12;54(3). doi: 10.1093/ije/dyaf053.
3
Design and analysis considerations for investigating patient subgroups of interest within cancer clinical trials.在癌症临床试验中研究感兴趣的患者亚组的设计与分析考量
J Natl Cancer Inst Monogr. 2025 Mar 1;2025(68):22-29. doi: 10.1093/jncimonographs/lgae045.
4
Patient and Public Perceptions in Canada About Decentralized and Hybrid Clinical Trials: "It's About Time we Bring Trials to People".加拿大民众对分散式和混合临床试验的看法:“是时候把试验带给人们了”。
Ther Innov Regul Sci. 2024 Sep;58(5):965-977. doi: 10.1007/s43441-024-00665-y. Epub 2024 Jun 21.
5
TBCRC 057: Survey about willingness to participate in cancer clinical trials during the pandemic.TBCRC 057:关于疫情期间参与癌症临床试验意愿的调查。
Cancer Med. 2024 Mar;13(5):e7090. doi: 10.1002/cam4.7090.
6
Narrative review of telemedicine applications in decentralized research.远程医疗在分散式研究中的应用叙述性综述
J Clin Transl Sci. 2024 Jan 22;8(1):e30. doi: 10.1017/cts.2024.3. eCollection 2024.
7
Methods and perceptions of success for patient recruitment in decentralized clinical studies.分散式临床研究中患者招募的方法与成功认知
J Clin Transl Sci. 2023 Oct 6;7(1):e232. doi: 10.1017/cts.2023.643. eCollection 2023.
8
Leveraging Virtual Technology to Conduct Clinical Trials in Inflammatory Bowel Disease.利用虚拟技术开展炎症性肠病的临床试验。
Gastroenterol Hepatol (N Y). 2023 Aug;19(8):468-474.
9
Towards a conceptual framework for addressing state-level barriers to decentralized clinical trials in the U.S.构建一个解决美国州级分散式临床试验障碍的概念框架
J Clin Transl Sci. 2023 Jul 3;7(1):e162. doi: 10.1017/cts.2023.584. eCollection 2023.
10
Clinical trial reform in the post-COVID era.新冠疫情后时代的临床试验改革。
Ther Adv Med Oncol. 2023 Jul 8;15:17588359231183676. doi: 10.1177/17588359231183676. eCollection 2023.

本文引用的文献

1
COVID-19 Pandemic and Cancer Clinical Trial Pandemonium: Finding the Silver Lining.COVID-19大流行与癌症临床试验的混乱局面:寻找一线希望。
J Immunother Precis Oncol. 2020 Nov 16;4(2):64-66. doi: 10.36401/JIPO-20-X7. eCollection 2021 May.
2
Rethinking cancer clinical trials for COVID-19 and beyond.重新思考癌症临床试验在 COVID-19 及以后的应用。
Nat Cancer. 2020 Jun;1(6):568-572. doi: 10.1038/s43018-020-0083-x.
3
Rethinking Cancer Clinical Trial Conduct Induced by COVID-19: An Academic Center, Industry, Government, and Regulatory Agency Perspective.重新思考 COVID-19 引发的癌症临床试验实施:学术中心、工业界、政府和监管机构的观点。
Cancer Discov. 2021 Aug;11(8):1881-1885. doi: 10.1158/2159-8290.CD-21-0850. Epub 2021 Jul 21.
4
Clinical research during the COVID-19 pandemic: The role of virtual visits and digital approaches.2019冠状病毒病大流行期间的临床研究:虚拟问诊和数字方法的作用
J Clin Transl Sci. 2021 Mar 8;5(1):e102. doi: 10.1017/cts.2021.19.
5
Barriers and Facilitators to Telemedicine: Can You Hear Me Now?远程医疗的障碍与促进因素:你能听清我说话吗?
Am Soc Clin Oncol Educ Book. 2021 Mar;41:25-36. doi: 10.1200/EDBK_320827.
6
Uveitis Specialists Harnessing Disruptive Technology during the COVID-19 Pandemic and Beyond.葡萄膜炎专家在新冠疫情期间及之后利用颠覆性技术。
Semin Ophthalmol. 2021 May 19;36(4):296-303. doi: 10.1080/08820538.2021.1896753. Epub 2021 Mar 23.
7
COVID-19 and Clinical Trials: Current Challenges and Future Directions.新型冠状病毒肺炎与临床试验:当前挑战与未来方向。
Rev Recent Clin Trials. 2021;16(3):258-261. doi: 10.2174/1574887116666210122160705.
8
"When Offered to Participate": A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials.“被邀请参与时”:关于患者同意参与癌症临床试验的系统评价与荟萃分析
J Natl Cancer Inst. 2021 Mar 1;113(3):244-257. doi: 10.1093/jnci/djaa155.
9
Reimagining Global Oncology Clinical Trials for the Postpandemic Era: A Call to Arms.重塑大流行后时代的全球肿瘤学临床试验:战斗的号角。
JCO Glob Oncol. 2020 Sep;6:1357-1362. doi: 10.1200/GO.20.00346.
10
Telemedicine in Germany During the COVID-19 Pandemic: Multi-Professional National Survey.新冠疫情期间德国的远程医疗:多专业全国性调查
J Med Internet Res. 2020 Aug 5;22(8):e19745. doi: 10.2196/19745.