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Background <p>In recent years, the involvement of patient representatives has become increasingly important in the planning, conduct, and communication of clinical trials. Their participation is expected to improve the relevance of research questions, strengthen recruitment, enhance feasibility and patient compliance, and foster public trust in research.</p> Main body <p>The Coordination Center for Clinical Trials (KKS) in Heidelberg identified a need for structured support regarding participation processes and therefore established a “Competence Office for Patient Participation” (PPI Office, PPI = public and patient involvement). The PPI Office acts as a central service structure for clinical researchers at Heidelberg University Hospital (UKHD) and the Medical Faculty of Heidelberg University (MFHD). It complements existing structures, such as patient advisory boards, and is independent of specific departments or indication areas. The PPI Office consolidates a wide range of services related to patient involvement. These include the development of fact sheets, training activities for patient representatives and researchers, establishing a pool of trained patient representatives, providing a contract template, and offering consulting services for researchers.</p> Conclusion <p>The “Competence Office for Patient Participation” (PPI Office) is a newly established and valuable institution at UKHD and MFHD that supports clinical researchers in all aspects of patient involvement. This article shares experiences and aims to provide guidance for other institutions planning to set up similar support structures.</p>

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Establishment of a competence office for patient involvement (PPI Office) at a German university hospital

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  • 发表日期：

    2026年5月26日

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  • Bettina C. Thomas,
  • Friederike Dominick,
  • Andrea Seidel-Glätzer,
  • Gregor B. Ottawa,
  • Steffen P. Luntz

摘要

Background

In recent years, the involvement of patient representatives has become increasingly important in the planning, conduct, and communication of clinical trials. Their participation is expected to improve the relevance of research questions, strengthen recruitment, enhance feasibility and patient compliance, and foster public trust in research.

Main body

The Coordination Center for Clinical Trials (KKS) in Heidelberg identified a need for structured support regarding participation processes and therefore established a “Competence Office for Patient Participation” (PPI Office, PPI = public and patient involvement). The PPI Office acts as a central service structure for clinical researchers at Heidelberg University Hospital (UKHD) and the Medical Faculty of Heidelberg University (MFHD). It complements existing structures, such as patient advisory boards, and is independent of specific departments or indication areas. The PPI Office consolidates a wide range of services related to patient involvement. These include the development of fact sheets, training activities for patient representatives and researchers, establishing a pool of trained patient representatives, providing a contract template, and offering consulting services for researchers.

Conclusion

The “Competence Office for Patient Participation” (PPI Office) is a newly established and valuable institution at UKHD and MFHD that supports clinical researchers in all aspects of patient involvement. This article shares experiences and aims to provide guidance for other institutions planning to set up similar support structures.