Introduction
Health system was created to improve patients’ health and well-being. However, as medical knowledge expanded, specializations increased, and new technologies emerged, the health system created more or less involuntary a gap between what health professionals perceive as patients’ needs and preferences and what patients actually needs and value.
"The history of modern science has been shaped by the separation of citizens from scientists. The cleaving originated in the understable desire to create a profession. Scientists developed professional guidelines and established academic programs where people could acquire the necessary skills and the credentials that went along with them. But the effort eventually went too far. Scientists set themselves apart from the issues that were most urgent to patients struggling to find treatments and answers today. They essentially built a cathedral without people in it."
Amy Dockser Marcus – We the scientist – 2023
In 2013, WHO published a policy framework calling on health systems to reassess their practices and to place patients, their families, and the wider public at the center of healthcare decision-making.
“Health systems and services have become overly biomedical oriented, disease focused, technology driven and doctor dominated […] It is time to pay more attention to the demand side – patients, families, communities and society at large” – WHO – 2013
Unfortunately, this observation also applies to clinical research, whether in the development of new treatments or medical devices. When designing a clinical research project, researchers often rely on their own observations, expertise, or knowledge, but rarely seek input directly from their patients or members of the public.
As a result, involving patients and the public in clinical research is no longer simply an option, but it has become an essential component to develop a relevant, patient-centered and impact full research.
Modules
Module Summary
This module introduces the purpose, principles, and challenges of PPI in clinical research. Learners will distinguish between involvement, engagement, and participation, and explore how these concepts differ in the research process. The module also examines the scientific and ethical rationale for PPI, highlighting its potential to improve the relevance, quality, transparency, and impact of clinical research while considering the practical challenges of implementing meaningful involvement.
Learning outcomes
Explain the purpose, principles, and challenges of PPI in clinical research.
Learning objectives
- Distinguish the terms involvement from participation and engagement in clinical research.
- Identify the different PPI approach that can be used to implement PPI in clinical research.
- Justify the ethical and scientific relevance and benefits of PPI in clinical research.
- Identify common misconceptions and barriers to PPI implementation in clinical research.
- Develop strategies to address common misconceptions and barriers to PPI implementation in clinical research.
Module Summary
This module focuses on planning and implementing a practical PPI strategy for clinical research. Learners will explore how to define clear PPI goals, select appropriate involvement activities that align with different stages of the research process, and develop a realistic budget and resource plan. The module emphasizes practical approaches to embedding meaningful and sustainable PPI within clinical research projects.
Learning outcomes
Develop a practical PPI strategy including clear goals, suitable activities, and a realistic budget.
Learning objectives
- Develop a realistic strategy to implement PPI in a clinical study based on its characteristics, needs and stage in the research lifecycle.
- Estimate the budget and logistical requirements needed to support PPI activities in clinical research.
Module Summary
This module explores how to establish and sustain an inclusive PPI panel that meets the needs of a clinical research project. Learners will examine strategies for identifying and recruiting appropriate contributors, building a panel that reflects diverse perspectives and experiences, and creating an inclusive environment that supports meaningful, long-term participation and engagement.
Learning outcomes
Create an inclusive and sustainable PPI panel that is appropriate for the needs of a research project.
Learning objectives
- Identify who can be involved as a PPI contributor.
- Differentiate the different expertise level of PPI contributors.
- Identify barriers to participation.
- Apply equity, diversity, and inclusion principles to engage underrepresented groups.
- Explain key principles and practices for sustaining an inclusive and diverse PPI panel over time.
- Apply strategies to support inclusive participation and long-term engagement of PPI contributors in research activities.
Module Summary
This module develops the communication and facilitation skills needed to support effective PPI in clinical research. Learners will explore the principles of health literacy and how to communicate research information in clear, accessible ways. The module also covers practical strategies for facilitating productive and inclusive PPI panel meetings, fostering meaningful dialogue, respectful collaboration, and active participation.
Learning outcomes
Demonstrate effective communication strategies that support productive PPI interactions.
Learning objectives
- Explain the importance of Health Literacy in clinical research.
- Identify factors that influence Health Literacy in clinical research.
- Critically assess health information sources (e.g., website, social media, pamphlets).
- Identify potential language barriers for PPI contributors inside a text.
- Write a lay summary for a research project.