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科学联合:策划合作。

Syndication in science: Curated collaboration.

机构信息

Koneksa Health, New York, New York, USA.

Takeda Pharmaceuticals, Cambridge, Massachusetts, USA.

出版信息

Clin Transl Sci. 2024 Dec;17(12):e70085. doi: 10.1111/cts.70085.

DOI:10.1111/cts.70085
PMID:39614378
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11606892/
Abstract

Development and validation of digital measures require dedicated clinical studies, which can be conducted by a single study sponsor or a precompetitive collaboration. In this perspective, we propose an alternative model, data syndication, a curated collaboration, which foresees a technology provider being a founding member with biopharmaceutical sponsors and other stakeholders joining. Its main advantages are the speed of the study startup and the opportunity for real-time data streaming.

摘要

数字测量的开发和验证需要专门的临床研究,可以由一个研究赞助商或一个竞争前的合作来进行。在这种情况下,我们提出了一种替代模式,即数据联合,一种经过策划的合作,其中技术提供商作为创始成员,生物制药赞助商和其他利益相关者加入。它的主要优点是研究启动的速度和实时数据流的机会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5dfc/11606892/f86b9aea2eba/CTS-17-e70085-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5dfc/11606892/f86b9aea2eba/CTS-17-e70085-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5dfc/11606892/f86b9aea2eba/CTS-17-e70085-g001.jpg

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1
Syndication in science: Curated collaboration.科学联合:策划合作。
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本文引用的文献

1
Regulatory Pathways for Qualification and Acceptance of Digital Health Technology-Derived Clinical Trial Endpoints: Considerations for Sponsors.数字健康技术衍生的临床试验终点的资格认定和接受的监管途径:申办者的考量因素
Clin Pharmacol Ther. 2025 Jan;117(1):56-72. doi: 10.1002/cpt.3398. Epub 2024 Aug 15.
2
Digital technologies: Innovations that transform the face of drug development.数字技术:改变药物研发面貌的创新。
Clin Transl Sci. 2023 Aug;16(8):1323-1330. doi: 10.1111/cts.13533. Epub 2023 May 8.
3
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.
4
Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience.基于目标的生物计量监测技术:利用实验室生物标志物经验。
Clin Transl Sci. 2021 Jan;14(1):62-74. doi: 10.1111/cts.12865. Epub 2020 Aug 25.
5
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.
6
Wearable Devices in Clinical Trials: Hype and Hypothesis.可穿戴设备在临床试验中的应用:炒作与假设。
Clin Pharmacol Ther. 2018 Jul;104(1):42-52. doi: 10.1002/cpt.966. Epub 2018 Apr 2.
7
Opening up to precompetitive collaboration.开放竞争前合作。
Sci Transl Med. 2010 Oct 6;2(52):52cm26. doi: 10.1126/scitranslmed.3001515.
8
Utility of adiponectin as a biomarker predictive of glycemic efficacy is demonstrated by collaborative pooling of data from clinical trials conducted by multiple sponsors.多个主办方开展的临床试验数据的联合汇总证明了脂联素作为预测血糖疗效生物标志物的效用。
Clin Pharmacol Ther. 2009 Dec;86(6):619-25. doi: 10.1038/clpt.2009.88. Epub 2009 Jun 24.