Klin Farmakol Farm. 2026;40(2):112-115 | DOI: 10.36290/far.2026.025
Patient and Public Involvement in clinical research: from regulatory requirements to partnerships with patients
- CZECRIN, Lékařská fakulta Masarykovy univerzity, Brno
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.
Keywords: Patient and Public Involvement, clinical research, clinical trial design, patient advocate, patient reported outcomes.
Received: April 16, 2026; Revised: June 15, 2026; Accepted: June 15, 2026; Published: July 1, 2026 Show citation
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References
- Egher C, Zvonareva O. Knowledge-based Representation: Patient Engagement in Drug Development. Health Expect. 2024;27(1):e13912.
Go to original source... - Geißler J, Isham E, Hickey G, et al. Patient Involvement in Clinical Trials. Commun Med. 2022;2(1):94. Go to original source...
- U.S. Food and Drug Administration (FDA). Patient-Focused Drug Development: Collecting Comprehensive and Representative Input [Internet]. FDA; 2020 [cited 11-02-2026]. Available from: http://resource.nlm.nih.gov/9918230998606676.
- U.S. Food and Drug Administration (FDA). Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making [Internet]. FDA; 2023 [cited 11-02-2026]. Available from: https://www.hhs.gov/guidance/document/patient-focused-drug-development-incorporating-clinical-outcome-assessments-endpoints.
- Amjad A, Ratcliffe N, Smith AL, et al. Patient and Public Involvement in Laboratory Based Research: Reflections on Six Studies.
- Arumugam A, Phillips LR, Moore A, et al. Patient and Public Involvement in Research: A Review of Practical Resources for Young Investigators. BMC Rheumatol. 2023;7(1):2. Go to original source...
- The Lancet Healthy Longevity. Increasing Patient and Public Involvement in Clinical Research. Lancet Healthy Longev. 2024;5(2):e83. Go to original source...
- Tong A, Scholes-Robertson N, Hawley C, et al. Patient-Centred Clinical Trial Design. Nat Rev Nephrol. 2022;18(8):514-523. Go to original source...
- Jackson-Perry D, Cart-Richter E, Haerry D, et al. Patient and Public Involvement in HIV Research: A Mapping Review and Development of an Online Evidence Map. J Int AIDS Soc. 2024;27(11):e26385. Go to original source...
- U.S. Food and Drug Administration (FDA). Patient-Focused Drug Development: Methods to Identify What Is Important to Patients [Internet]. FDA; 2022 [cited 11-02-2026]. Available from: https://www.hhs.gov/guidance/document/patient-focused-drug-development-methods-identify-what-important-patients-guidance.
- U.S. Food and Drug Administration (FDA). Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments [Internet]. FDA; 2022 [cited 11-02-2026]. Available from: https://www.hhs.gov/guidance/document/patient-focused-drug-development-methods-identify-what-important-patients-guidance.
- Dews SA, Bassi A, Buckland S, et al. Characterising Meaningful Patient and Public Involvement in the Pharmaceutical Industry Research Setting: A Retrospective Quality Assessment. BMJ Open. 2023;13(8):e071339. Go to original source...
- Sand AS, Grimsgaard S, Pettersen I. Patient and Public Involvement in Health Research: A Nordic Perspective. Scand J Public Health. 2020;48(1):119-121. Go to original source...
- Schilling I, Herbon C, Jilani H, et al. Aktive Beteiligung von Patientinnen an klinischer Forschung - Eine Einführung. Z Evid Fortbild Qual Gesundhwes. 2020;155:56-63. Go to original source...
- Zeissler ML, Bakshi N, Bartlett M, et al. Patient and Public Involvement and Engagement in the Development of a Platform Clinical Trial for Parkinson's Disease: An Evaluation Protocol. J Parkinsons Dis. 2024;14(4):809-821. Go to original source...