Eberle Deborah, Bauer Annina, Landgraf Cordula, Roos Joëlle, Grossmann Regina
Clinical Trials Center Zurich, University Hospital Zurich, Zurich, Switzerland.
University of Zurich, Institute of Biomedicine, Zurich, Switzerland.
Swiss Med Wkly. 2024 Dec 6;154:3563. doi: 10.57187/s.3563.
While patient and public involvement (PPI) in clinical research contributes substantially to research ethics, feasibility and quality, the uptake and implementation of PPI-based approaches in Switzerland remain unknown. This study aimed to evaluate the current state and acceptance of PPI in academic clinical research in Switzerland, with the goal of developing recommendations for its future implementation and development.
A sequential explanatory mixed-methods study was conducted to assess the current landscape and acceptance of PPI in academic clinical research across different stakeholder groups in Switzerland. The groups were "Patients and Public", "Researchers", "Staff Members of Academic Research Infrastructure (ARI)" and representatives from "Regulatory and Funding Bodies". Data was collected through a combination of surveys and semi-structured interviews. The survey results were analysed descriptively, while interview data was analysed qualitatively. The results were further synthesised into a SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis.
A total of 123 survey responses were collected.Surveys revealed great support and acceptance for PPI in academic clinical research in Switzerland across all stakeholder groups. Despite this support, several challenges were identified, including gaps in training, limited funding opportunities and insufficient infrastructure to facilitate PPI.
The current framework for PPI in Switzerland is in an early stage of development. A joint effort by all stakeholders is needed to catch up with international progress to reach high-level ethical and quality standards. A basic framework for PPI in academic clinical research in Switzerland should be implemented, including guidelines for qualification and collaboration, best practices as well as widespread information for patients, the public and researchers. Further needed are training opportunities in "PPI in clinical research" for all stakeholders as well as sustainable sources of funding.
虽然患者和公众参与（PPI）临床研究对研究伦理、可行性和质量有重大贡献，但基于PPI的方法在瑞士的采用和实施情况仍不为人知。本研究旨在评估瑞士学术临床研究中PPI的现状和接受程度，以期为其未来的实施和发展提出建议。
开展了一项序列解释性混合方法研究，以评估瑞士不同利益相关者群体对学术临床研究中PPI的现状和接受程度。这些群体包括“患者和公众”、“研究人员”、“学术研究基础设施（ARI）工作人员”以及“监管和资助机构”的代表。通过调查和半结构化访谈相结合的方式收集数据。对调查结果进行描述性分析，对访谈数据进行定性分析。结果进一步综合成SWOT（优势、劣势、机会和威胁）分析。
共收集到123份调查问卷回复。调查显示，瑞士所有利益相关者群体对学术临床研究中的PPI都给予了大力支持和认可。尽管有这种支持，但仍发现了一些挑战，包括培训方面的差距、有限的资金机会以及促进PPI的基础设施不足。
瑞士目前的PPI框架尚处于发展初期。所有利益相关者需要共同努力，以赶上国际进展，达到高水平的伦理和质量标准。应实施瑞士学术临床研究中PPI的基本框架，包括资格认定和合作指南、最佳实践以及面向患者、公众和研究人员的广泛宣传。还需要为所有利益相关者提供“临床研究中的PPI”培训机会以及可持续的资金来源。
