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A review on the evolving environment of medical device real-world evidence regulation on market access in the USA.

作者信息

Shi Lizheng, Xuan Dennis, Jakovljevic Mihajlo

机构信息

School of Public Health and Tropical Medicine, Health Systems Analytics Research Center, Tulane University, New Orleans, LA, USA.

UNESCO-The World Academy of Sciences TWAS, Trieste, 34100, Italy.

出版信息

Cost Eff Resour Alloc. 2024 Oct 25;22(1):75. doi: 10.1186/s12962-024-00582-9.

DOI:10.1186/s12962-024-00582-9
PMID:39456032
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11515808/
Abstract
摘要

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本文引用的文献

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Development of the China's list of ambulatory care sensitive conditions (ACSCs): a study protocol.中国门诊医疗敏感条件（ACSCs）清单的制定：一项研究方案。
Glob Health Res Policy. 2024 Mar 19;9(1):11. doi: 10.1186/s41256-024-00350-5.
2
Real-world evidence for regulatory decision-making: updated guidance from around the world.用于监管决策的真实世界证据：来自世界各地的最新指南。
Front Med (Lausanne). 2023 Oct 30;10:1236462. doi: 10.3389/fmed.2023.1236462. eCollection 2023.
3
Strategic management and organizational culture of medical device companies in relation to corporate performance.医疗器械公司的战略管理和组织文化与企业绩效的关系。
J Med Econ. 2023 Jan-Dec;26(1):781-792. doi: 10.1080/13696998.2023.2224168.
4
Evidence-based objective performance criteria for the evaluation of hip and knee replacement devices and technologies.基于证据的髋关节和膝关节置换装置和技术的客观绩效评估标准。
Int J Surg. 2023 May 1;109(5):1125-1135. doi: 10.1097/JS9.0000000000000169.
5
Access and reimbursement pathways for digital health solutions and diagnostic devices: Current scenario and challenges.数字健康解决方案和诊断设备的准入与报销途径：现状与挑战
Front Med Technol. 2023 Feb 20;5:1101476. doi: 10.3389/fmedt.2023.1101476. eCollection 2023.
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Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.通过协调注册网络推进医疗器械的真实世界证据
BMJ Surg Interv Health Technol. 2022 Nov 11;4(Suppl 1):e000123. doi: 10.1136/bmjsit-2021-000123. eCollection 2022.
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Real-world data: a brief review of the methods, applications, challenges and opportunities.真实世界数据：方法、应用、挑战和机遇的简要回顾。
BMC Med Res Methodol. 2022 Nov 5;22(1):287. doi: 10.1186/s12874-022-01768-6.
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HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force.协调方案模板以提高治疗效果的真实世界证据研究中假说评估的可重复性：ISPE/ISPOR 联合工作组的良好实践报告。
Pharmacoepidemiol Drug Saf. 2023 Jan;32(1):44-55. doi: 10.1002/pds.5507. Epub 2022 Oct 10.
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Technol Health Care. 2022;30(6):1315-1329. doi: 10.3233/THC-220284.