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一种在研究者发起的临床试验中实现患者和公众参与的方法。

An approach to implementing patient and public involvement in investigator-initiated clinical trials.

作者信息

Bivens Kristin Marie, Guyon Amélie J A A, Behan Valerie, Segelov Eva

机构信息

Department of Clinical Research, University of Bern, Bern, Switzerland.

Department of Radiation Oncology, Bern University Hospital, Inselspital, Bern, Switzerland.

出版信息

Swiss Med Wkly. 2025 Jun 24;155:4563. doi: 10.57187/s.4563.

Abstract

As patient and public involvement (PPI) in academic clinical research, especially clinical trials, is gaining recognition, including acceptance and implementation, questions arise about how to establish an effective "basic framework for PPI in academic clinical research" for all stakeholders in Switzerland. In this Viewpoint, the authors focus on one aspect of the survey and interview results reported by Eberle and colleagues from PPI contributors, researchers, academic research infrastructure staff, and representatives of regulatory and funding bodies to identify a possible direction for a basic PPI framework in Switzerland. Specifically, they describe how they prepare two groups of stakeholders - clinical researchers and PPI contributors - for collaboration. They present clear definitional distinctions to help clinical researchers prepare for the 2025 call for proposals from the Swiss National Science Foundation (SNSF) for Investigator-Initiated Clinical Trials (IICT) and provide important background information that is essential for understanding the fundamentals of PPI.

摘要

随着患者及公众参与(PPI)在学术临床研究尤其是临床试验中日益得到认可,包括被接受和实施,关于如何为瑞士的所有利益相关者建立一个有效的“学术临床研究中PPI的基本框架”的问题也随之出现。在这一观点文章中,作者聚焦于Eberle及其同事报告的来自PPI贡献者、研究人员、学术研究基础设施人员以及监管和资助机构代表的调查及访谈结果的一个方面,以确定瑞士基本PPI框架的一个可能方向。具体而言,他们描述了如何让两组利益相关者——临床研究人员和PPI贡献者——为合作做好准备。他们给出了清晰的定义区分,以帮助临床研究人员为瑞士国家科学基金会(SNSF)2025年关于研究者发起的临床试验(IICT)的提案征集做好准备,并提供理解PPI基本原理所必需的重要背景信息。

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