Opportunities and challenges of active patient involvement in clinical research in Germany - from the perspectives of a patient representative, a clinical researcher and two staff members of research funding management

Background: Active involvement of patients in clinical research is increasingly demanded in Germany. It has great potential to increase the quality and relevance of research and to contribute to patient empowerment. However, patients, researchers and research funders have experienced that the implementation of patient involvement is accompanied by cultural, practical and personal challenges. The aim of this article is to discuss the opportunities and challenges of patient involvement in Germany from the perspective of the stakeholders involved. Method: A patient representative, a clinical researcher and two staff members from research funding management were invited to discuss the opportunities and challenges of patient involvement. Their perspectives were recorded in two written open survey rounds. The answers were analyzed using qualitative content analysis. Result: In the opinion of the stakeholders involved, the increasing involvement of patients in clinical research is an opportunity to promote the practical relevance of research and the implementation of studies, to increase their acceptance by the target group and to improve the uptake of research results in practice. However, the implementation of patient involvement was also perceived as challenging. They described problems with regard to the acquisition and selection of patients, the training of the patients and the specifications and support structures for the implementation of patient involvement. Discussion: While patient involvement in clinical research offers great potential, the development of appropriate structures and framework conditions for its implementation is still virtually unestablished in Germany. This needs to include, among other things, creating a broader awareness of the potential of patient involvement, developing training programs for patients and researchers, providing sufficient, mainly project-independent resources and ensuring regular evaluations.