Blom Johanna M C, Rivi Veronica, Tascedda Fabio, Pani Luca
Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.
Center for Neuroscience and Neurotechnology, University of Modena and Reggio Emilia, Modena, Italy.
Front Pharmacol. 2025 Jul 16;16:1570899. doi: 10.3389/fphar.2025.1570899. eCollection 2025.
Trust and trustworthiness are critical to the success of clinical research, profoundly influencing participant engagement, data integrity, and study outcomes. These behaviors emerge from complex, dynamic interactions within the clinical research ecosystem, involving stakeholders such as sponsors, participants, clinicians, researchers, and regulatory bodies. The rapid development of COVID-19 vaccines has underscored the potential of scientific advancements to build public trust in the scientific outcomes, while also exposing vulnerabilities in the procedural trust framework due to misinformation and historical unethical practices. This paper explores trust and trustworthiness as emergent properties within the complex systems of clinical research, highlighting their evolution through transparent communication, participant empowerment, and ethical governance. A systems approach is emphasized, where trust develops holistically, influenced by regulatory frameworks, interpersonal relationships, and the overall research environment. Practical implications include the adoption of adaptive consent models, interdisciplinary collaboration, and the integration of continuous feedback mechanisms. To address trust erosion, especially among marginalized communities, we advocate for participatory research approaches and the development of new professional competencies, such as the role of a Clinical Research Liaison. This role would ensure ongoing alignment with community needs, enhance transparency, and maintain ethical standards, ultimately fostering a research environment where trust and trustworthiness thrive, benefiting both participants and the broader scientific community. A roadmap for future efforts includes the systematic incorporation of these elements into clinical research practices to enhance trust and improve research outcomes.
信任和可信赖性对于临床研究的成功至关重要，深刻影响着参与者的参与度、数据完整性和研究结果。这些行为源自临床研究生态系统内复杂、动态的互动，涉及赞助商、参与者、临床医生、研究人员和监管机构等利益相关者。新冠疫苗的迅速研发凸显了科学进步建立公众对科学成果信任的潜力，同时也因错误信息和历史上的不道德行为暴露了程序信任框架中的脆弱性。本文探讨信任和可信赖性作为临床研究复杂系统中的新兴属性，强调它们通过透明沟通、参与者赋权和道德治理的演变。强调采用系统方法，信任在监管框架、人际关系和整体研究环境的影响下全面发展。实际影响包括采用适应性同意模型、跨学科合作以及整合持续反馈机制。为解决信任侵蚀问题，尤其是在边缘化社区中，我们倡导采用参与式研究方法并发展新的专业能力，如临床研究联络官的角色。这一角色将确保与社区需求持续保持一致，提高透明度并维持道德标准，最终营造一个信任和可信赖性蓬勃发展的研究环境，使参与者和更广泛的科学界都受益。未来努力的路线图包括将这些要素系统地纳入临床研究实践，以增强信任并改善研究结果。
