Suppr超能文献

在兽医监管应用中使用真实世界数据作为关键证据。

Use of real-world data as pivotal evidence in veterinary regulatory applications.

作者信息

Bruno Raffaele

机构信息

Zoetis Veterinary Medicine Research & Development, Zaventem, Belgium.

出版信息

Front Vet Sci. 2025 Jun 18;12:1588068. doi: 10.3389/fvets.2025.1588068. eCollection 2025.

Abstract

Real-world data (RWD) has the potential to complement or serve as an alternative to randomized clinical trials (RCTs) in veterinary medicine, mirroring trends observed in human medicine. Sourced from diverse platforms including digital databases and wearable devices, RWD may provide valuable insights into the effectiveness, safety, and broader societal impacts of veterinary medicinal products. Although its role as pivotal evidence in veterinary drug submissions remains limited due to challenges related to data quality, methodological rigor, and regulatory acceptance, reflections on its potential applications in the veterinary domain are already possible.

摘要

真实世界数据(RWD)有潜力补充或替代兽医学中的随机临床试验(RCT),这反映了人类医学中观察到的趋势。RWD来源于包括数字数据库和可穿戴设备在内的各种平台,可能为兽用药品的有效性、安全性及更广泛的社会影响提供有价值的见解。尽管由于数据质量、方法严谨性和监管接受度等相关挑战,其在兽药申报中作为关键证据的作用仍然有限,但对其在兽医领域潜在应用的思考已经可行。

相似文献

1
Use of real-world data as pivotal evidence in veterinary regulatory applications.
Front Vet Sci. 2025 Jun 18;12:1588068. doi: 10.3389/fvets.2025.1588068. eCollection 2025.
4
Management of urinary stones by experts in stone disease (ESD 2025).
Arch Ital Urol Androl. 2025 Jun 30;97(2):14085. doi: 10.4081/aiua.2025.14085.
6
Direct composite resin fillings versus amalgam fillings for permanent posterior teeth.
Cochrane Database Syst Rev. 2021 Aug 13;8(8):CD005620. doi: 10.1002/14651858.CD005620.pub3.
7
10
Oral aspirin for treating venous leg ulcers.
Cochrane Database Syst Rev. 2016 Feb 18;2(2):CD009432. doi: 10.1002/14651858.CD009432.pub2.

本文引用的文献

5
Real-world data: a brief review of the methods, applications, challenges and opportunities.
BMC Med Res Methodol. 2022 Nov 5;22(1):287. doi: 10.1186/s12874-022-01768-6.
7
The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications.
Clin Pharmacol Ther. 2022 Jan;111(1):135-144. doi: 10.1002/cpt.2474. Epub 2021 Nov 22.
10
A Review of Enteric Methane Emission Measurement Techniques in Ruminants.
Animals (Basel). 2020 Jun 8;10(6):1004. doi: 10.3390/ani10061004.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验