设计患者对皮下医疗器械的偏好研究：结合卫生权威、科学建议和患者观点。

IF 2 4区医学 Q4 MEDICAL INFORMATICS

Therapeutic innovation & regulatory science Pub Date : 2025-05-01 Epub Date: 2025-02-26 DOI:10.1007/s43441-024-00725-3

Marie Picci, Nigel S Cook, Byron Jones, Mo Zhou, Conny Berlin, Christine Sturchler, Clemence Martinez, Irene Garcia Baena, Lauren Ziegler, Harriet Gaunt, Brad Mason, Dominique Hamerlijnck, Yoshiyuki Majima

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引用次数: 0

摘要

本文描述了一项患者偏好研究的计划，以评估用于皮下（SC）递送高剂量/大容量（例如，bbb20 ml）药物的设备特性。多种来源，包括定性患者访谈，患者伴侣的参与，以及征求美国食品和药物管理局（FDA）的意见，用于完善偏好研究方案开发中的属性和水平，以调查多发性硬化症（MS）患者认为高剂量SC给药的医疗器械特征重要的是什么。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Designing a Patient Preference Study on Subcutaneous Medical Devices: Incorporating Health Authority Scientific Advice and Patient Perspectives.

This paper describes the planning of a patient preference study for evaluating device features for the subcutaneous (SC) delivery of high dose/large volume (e.g., > 2 ml) of drugs. Multiple sources, including qualitative patient interviews, the involvement of patient partners, and solicitation of advice from the US Food and Drugs Administration (FDA), were used to refine the attributes and levels in the development of a preference study protocol to investigate what Multiple Sclerosis (MS) patients consider important regarding medical device features for high dose SC administration.

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来源期刊

Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY

CiteScore

3.40

自引率

13.30%

发文量

127

期刊介绍： Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health. The focus areas of the journal are as follows: Biostatistics Clinical Trials Product Development and Innovation Global Perspectives Policy Regulatory Science Product Safety Special Populations