Given the increasing costs of medicines development and the financial consequences of market failure, incorporating PI early in biomedical research may reduce waste of R&D resources.

2017 Geissler Improving Patient Involvement in Medicines Research and Development

The reductions in cost and increases in NPV and ENPV all greatly exceed an investment of $100,000 in patient engagement. The reduction in development cost alone ($0.56MM for pre–phase 2, $2.1MM for pre–phase 3) as a result of having 1 less amendment exceeds the costs of engagement by a factor of 5 for pre–phase 2 and 21 for pre–phase 3. The gains in NPV and ENPV can be several hundred times the investment for engagements that avoid an amendment and improve the patient experience.

2018 Levitan Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI's Patient Groups and Clinical Trials Project

Integration of patients into the medicines development process needs to be structured and governed by clear rules and modes of operation to be effective and yield the best results for all stakeholders.

2018 Warner EUPATI guidance for patient involvement

Service user researchers may play a key role in establishing PPI in a scientific, hierarchical research environment. Adoption of a more democratic approach to involvement would build on the good work already being done and help to transform the culture and research processes. However, such an adoption requires considerable changes to the funding and policy environment orienting health research.

2020 Evans Between funder requirements and jobbing scientists: the evolution of patient and public involvement

A growing consensus is emerging that patient involvement is critical to clinical research and should happen as early as possible.
Patients and their caregivers may have more confidence in research outcomes if other patients have provided input to their development.

2023 Costa Adopting recommendations for implementing patient involvement in cancer research-a funders approach

Patients themselves are best placed to provide insights on the lived experience and to lead the analysis of such insights to bring the patient voice into peer-reviewed literature.
Patient insights can help healthcare professionals better understand the unmet needs of patients, which may facilitate shared decision-making.

2023 Lobban Evaluation of the quality of patient involvement in a patient-led analysis of the lived experience of a rare disease

It is our lives that are at stake, after all….' Many patient partners engage to prevent others from dealing with what they have; to help meet unmet needs of under-resourced communities; to develop, and to have a voice in research, policy, and clinical care

2023 Richards Reflections on patient engagement by patient partners: how it can go wrong

The present project serves as an example for how all relevant stakeholders can be involved in project design and study prioritization, since the steering group of the entire project was composed by HCPs as well as patient experts and advocates.

2023 Weiler-Wichtl Good to know - This is PPIE: Development of a training tool for public and patient involvement and engagement in pediatric oncological research

Among the benefits associated with PPIE in pediatric oncology, researchers name the increased relevance of research, higher patient satisfaction, more effective recruitment of participants and better acceptance and feasibility of research findings.

2024 Weiler-Wichtl Asking those who know their needs best: A framework for active engagement and involvement of childhood cancer survivors and parents in the process of psychosocial research—A workshop report

The PREFER Recommendations also advocate working with patients as research partners in the Patient Preference Study to increase the relevance, appropriateness, feasibility, and acceptability of the study design, as well as its conduct and the interpretation of study results.

2025 Picci Designing a Patient Preference Study on Subcutaneous Medical Devices:
Incorporating Health Authority Scientific Advice and Patient Perspectives

Institutions must value patient partners in research with fair and transparent compensation policies, or their commitments to equity will be hollow.
Compensation done right creates a seamless experience for patient partners, showing respect and commitment to inclusivity, enhancing collaboration and mutual trust.

2025 Price and Richards Patient partner research has a compensation crisis

Regulatory organizations such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) have long advocated for an integrated patient perspective in different regulatory activities of a medicine's lifecycle to improve trust in new approved medicines and in regulatory decisions.

2025 Talabardon Incorporating Patient Input into the Target Product Profile