• 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

Digital health technologies in clinical trials for central nervous system drugs: an EU regulatory perspective.

作者信息

Mantua Valentina, Arango Celso, Balabanov Pavel, Butlen-Ducuing Florence

出版信息

Nat Rev Drug Discov. 2021 Feb;20(2):83-84. doi: 10.1038/d41573-020-00168-z.

DOI:10.1038/d41573-020-00168-z
PMID:32994577
Abstract
摘要

相似文献

1
Digital health technologies in clinical trials for central nervous system drugs: an EU regulatory perspective.中枢神经系统药物临床试验中的数字健康技术:欧盟监管视角
Nat Rev Drug Discov. 2021 Feb;20(2):83-84. doi: 10.1038/d41573-020-00168-z.
2
Deficiencies in proposed new EU regulation of clinical trials.欧盟新提议的临床试验法规存在的缺陷。
BMJ. 2012 Dec 20;345:e8522. doi: 10.1136/bmj.e8522.
3
Digital Health Technology (DHT) in European Clinical Trials, How to Improve the Status-Quo of the Regulatory Landscape?数字健康技术(DHT)在欧洲临床试验中的应用,如何改善监管现状?
Ther Innov Regul Sci. 2024 Jul;58(4):610-613. doi: 10.1007/s43441-024-00657-y. Epub 2024 Apr 24.
4
Regulatory impediments jeopardizing the conduct of clinical trials in Europe funded by the National Institutes of Health.在欧洲,由美国国立卫生研究院资助的临床试验受到监管障碍的威胁。
Clin Trials. 2010 Dec;7(6):705-18. doi: 10.1177/1740774510376547. Epub 2010 Aug 20.
5
Requirements for generic anti-epileptic medicines: a regulatory perspective.通用抗癫痫药物的要求:监管视角
J Neurol. 2009 Dec;256(12):1966-71. doi: 10.1007/s00415-009-5231-2. Epub 2009 Jul 15.
6
Regulatory implications of good clinical practice. Towards harmonisation.《药物临床试验质量管理规范》的监管影响。迈向协调统一。
Drugs. 1993 Feb;45(2):171-6. doi: 10.2165/00003495-199345020-00002.
7
Drug regulatory developments. The European regulatory environment.药品监管发展。欧洲监管环境。
Eur J Pharm Sci. 2004 Jan;21(1):101-2.
8
Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective.促进新型候选药物的早期临床研究安全:欧盟监管视角。
Clin Pharmacol Ther. 2018 Apr;103(4):564-566. doi: 10.1002/cpt.899. Epub 2017 Nov 6.
9
Moving toward a paradigm shift in the regulatory requirements for pediatric medicines.朝着儿科药物监管要求的范式转变迈进。
Eur J Pediatr. 2016 Dec;175(12):1881-1891. doi: 10.1007/s00431-016-2781-z. Epub 2016 Sep 19.
10
The optimum time for drug licensing.药品许可的最佳时机。
Nat Rev Drug Discov. 2003 Sep;2(9):691-2. doi: 10.1038/nrd1181.

引用本文的文献

1
Remote Monitoring of Amyotrophic Lateral Sclerosis Using Digital Health Technologies: Shifting Toward Digitalized Care and Research?利用数字健康技术对肌萎缩侧索硬化症进行远程监测:是否正在向数字化护理和研究转变?
Neurology. 2025 Jul 8;105(1):e213738. doi: 10.1212/WNL.0000000000213738. Epub 2025 Jun 3.
2
A Hierarchical Framework for Selecting Reference Measures for the Analytical Validation of Sensor-Based Digital Health Technologies.用于为基于传感器的数字健康技术的分析验证选择参考测量的分层框架。
J Med Internet Res. 2025 Feb 7;27:e58956. doi: 10.2196/58956.
3
V3+ extends the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies.

本文引用的文献

1
Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs).验证、分析验证和临床验证(V3):确定生物识别监测技术(BioMeTs)适用性的基础。
NPJ Digit Med. 2020 Apr 14;3:55. doi: 10.1038/s41746-020-0260-4. eCollection 2020.
2
A systematic review of feasibility studies promoting the use of mobile technologies in clinical research.一项关于促进移动技术在临床研究中应用的可行性研究的系统评价。
NPJ Digit Med. 2019 Jun 6;2:47. doi: 10.1038/s41746-019-0125-x. eCollection 2019.
3
Transforming Psychiatry into Data-Driven Medicine with Digital Measurement Tools.
V3+扩展了V3框架,以确保基于传感器的数字健康技术以用户为中心并具备可扩展性。
NPJ Digit Med. 2025 Jan 24;8(1):51. doi: 10.1038/s41746-024-01322-2.
4
Patient-centric assessment of rheumatoid arthritis using a smartwatch and bespoke mobile app in a clinical setting.在临床环境中,使用智能手表和定制移动应用程序进行以患者为中心的类风湿关节炎评估。
Sci Rep. 2023 Oct 25;13(1):18311. doi: 10.1038/s41598-023-45387-7.
5
Innovative Technologies in CNS Trials: Promises and Pitfalls for Recruitment, Retention, and Representativeness.中枢神经系统试验中的创新技术:招募、留存和代表性方面的前景与陷阱
Innov Clin Neurosci. 2023 Sep 1;20(7-9):40-46. eCollection 2023 Jul-Sep.
6
How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints.多少证据才足够?研究资助者寻求监管机构接受数字健康技术衍生终点的经历。
Digit Biomark. 2023 Jun 8;7(1):45-53. doi: 10.1159/000529878. eCollection 2023 Jan-Dec.
7
"suMus," a novel digital system for arm movement metrics and muscle energy expenditure.“suMus”,一种用于手臂运动指标和肌肉能量消耗的新型数字系统。
Front Physiol. 2023 Jan 26;14:1057592. doi: 10.3389/fphys.2023.1057592. eCollection 2023.
8
Health horizons: Future trends and technologies from the European Medicines Agency's horizon scanning collaborations.健康视野:欧洲药品管理局前瞻扫描合作中的未来趋势与技术
Front Med (Lausanne). 2022 Dec 8;9:1064003. doi: 10.3389/fmed.2022.1064003. eCollection 2022.
9
Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital health technologies.赋能药物研发:利用影像技术的洞见,推动数字健康技术的发展。
Clin Transl Sci. 2023 Mar;16(3):383-397. doi: 10.1111/cts.13461. Epub 2022 Dec 2.
10
Novel clinical trial design and analytic methods to tackle challenges in therapeutic development in rare diseases.应对罕见病治疗研发挑战的新型临床试验设计与分析方法。
Ann Transl Med. 2022 Sep;10(18):1034. doi: 10.21037/atm-21-5496.
利用数字测量工具将精神病学转变为数据驱动型医学。
NPJ Digit Med. 2018 Aug 22;1:37. doi: 10.1038/s41746-018-0046-0. eCollection 2018.
4
European regulators' views on a wearable-derived performance measurement of ambulation for Duchenne muscular dystrophy regulatory trials.欧洲监管机构对杜氏肌营养不良症监管试验中可穿戴设备得出的活动能力表现测量的看法。
Neuromuscul Disord. 2019 Jul;29(7):514-516. doi: 10.1016/j.nmd.2019.06.003. Epub 2019 Jun 7.
5
A quantitative approach to neuropsychiatry: The why and the how.神经精神病学的定量方法:原因和方法。
Neurosci Biobehav Rev. 2019 Feb;97:3-9. doi: 10.1016/j.neubiorev.2017.12.008. Epub 2017 Dec 12.