Your Easy Guide to Clinical Studies

Patient and Public Involvement (PPI) refers to research carried out with or by patients and members of the public rather than to, about, or for them.

PPI is the active involvement of patients as partners in research, rather than as study participants.

 

It is important to distinguish between:

• Patient participants → subjects enrolled in the study
• Patient partners → contributors to study design, conduct, and dissemination

 

PPI involvement may:

• Ensure the research question reflects real patient needs, priorities, and lived experience.
• Ensure the research aligns with what matters most to those affected.
• Improve relevance and usefulness of study outcomes

 

PPI is not limited to a single phase but integrated throughout:

• Before the study → co-design, research question, study protocol
• During the study → advisory role, improving feasibility, compliance
• After the study → dissemination, return of results

As a SP-INV:

• Start PPI as early as possible
• Involve patients when shaping the research question
• Identify patient-relevant outcomes / endpoints
• Conduct individual patient interviews or a small focus groups. Use structured methods (not ad hoc consultation)
• Consult a patient advisory board (PAB). A PAB is a group of patients (also caregivers) who advice healthcare establishments, researchers, or other patient relevant companies on how to improve services, treatments, and patient experiences
• Document how patient input has influenced the research question
• Clarify level of involvement and define clear roles for patient partners. PPI can occur at different levels, such as informing, consulting, involving, collaborating, or empowering patients
• Ensure fair compensation and recognition

 

Avoid common pitfalls

• Late involvement (after key decisions have been made)
• Tokenistic participation
• Lack of feedback to patient partners
• Overburdening patients without support
• Unclear expectations or roles

 

Today both the Ethics Committee and funders increasingly require PPI involvement during study planning and implementation (e.g. SNSF, IICT programmes).

References

• Swiss Clinical Trial Organisation, see in particular – Patient & Public Involvement in Clinical Research
• Federal Office of Public Health (FOPH), Switzerland, see in particular – Spectra: Engaging with patients at all levels
• Swiss Cancer Institute, see in particular – Patient Public Involvement
• University of Basel, see in particular – Patient Public Involvement (PPI)
• University of Bern, see in particular – Patient Public Involvement (PPI)
• University of Zurich, see in particular – PPI - Patient Public Involvement
• Swiss National Science Foundation (SNSF), see in particular – Investigator Initiated Clinical Trials (IICT) – FAQ PPI preparatory grant