Publication details

Patient and Public Involvement v klinickém výzkumu: od regulatorních požadavků k partnerské spolupráci s pacienty

Title in English Patient and Public Involvement in clinical research: from regulatory requirements to partnerships with patients
Authors

BLAHYNKOVÁ Hana SOUČKOVÁ Lenka PAPIEŽ Adriána

Year of publication 2026
Type Peer-reviewed scientific article
Magazine / Source KLINICKÁ FARMAKOLOGIE A FARMACIE
MU Faculty or unit

Faculty of Medicine

Citation
web https://klinickafarmakologie.cz/pdfs/far/2026/02/07.pdf
Doi https://doi.org/10.36290/far.2026.025
Keywords Patient and public involvement; clinical research; clinical trial design; patient advocate; patient reported outcomes
Description In recent years, clinical research has increasingly focused on the systematic involvement of patients and the public (Patient and Public Involvement, PPI), with patients no longer viewed merely as study participants but also as active partners contributing to research planning. This approach enhances the relevance of research questions, improves the feasibility of studies, and increases the applicability of their results in clinical practice. The principles of patient involvement are reflected in modern methodological and regulatory frameworks, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice (ICH GCP R3), Quality by Design, and the latest revision of the Declaration of Helsinki. Patient involvement is also frequently required or strongly preferred in public grant programs today, such as Horizon Europe, the National Institute for Health and Care Research, or the Patient-Centered Outcomes Research Institute. Patients can contribute to formulating research questions, selecting relevant endpoints, improving the clarity of study documents, and reducing the burden on study participants. A patient advocate can serve as an important intermediary between patients and researchers, supporting meaningful patient involvement at each stage of research. Systematic PPI thus represents an important step toward higher-quality and more ethical clinical research.
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