Introduction
Over the past two decades, Patient and Public Involvement and Engagement (PPIE) has gained increasing attention in clinical research. Described as research carried out with or by patients rather than about or for them [1], PPIE represents a major change in how research is conceived and conducted. Patients are no longer regarded solely as research participants but as collaborators whose experiential knowledge can enrich study design, strengthen feasibility and ensure that research outcomes reflect the priorities of those most directly affected [2-6].
This recognition is gradually reshaping international standards. For example, in 2023, the World Health Organization published a “Framework for Meaningful Engagement” [7], the 2024 revision of the International Council for Harmonisation’s Good Clinical Practice (ICH E6) guidelines now explicitly references PPIE [8], and the revision of the Declaration of Helsinki reinforced the ethical imperative of involving patients and communities throughout research [9]. In 2025, major reporting guidelines implemented PPIE requirements [10, 11]. At the same time, national research organisations and funding agencies are increasingly encouraging, and in some cases requiring, the integration of PPIE into research funding applications.
In Switzerland, PPIE has only recently gained momentum, largely driven by the Swiss National Science Foundation (SNSF) which, since 2018, has gradually integrated PPIE as a requirement in its Investigator-Initiated Clinical Trials (IICT) programme. In 2022, the SNSF introduced a dedicated grant to support PPIE activities during grant preparation, and in 2025 swissethics (https://swissethics.ch/en) revised its protocol templates to include a section requiring the description of PPIE plans.
Clinical Trial Units (CTU), established in 2007 within Swiss academic hospitals, provide methodological and operational support for clinical research and researchers are strongly encouraged to collaborate with a CTU or equivalent infrastructure. Yet the role of CTUs in supporting PPIE remains undocumented.
This study aimed to describe current knowledge, experience, training, practices and perceived needs related to PPIE support among staff working in Swiss CTUs, and to explore how PPIE support is organised and implemented within these structures.
Materials and methods
Study design
This SPIRIT project includes three parts exploring the state of PPIE in research. Part 1 focuses on CTU staff, part 2 on researcher’s perspectives and part 3 on patients’ views. The present article reports the results of SPIRIT part 1. We used a sequential mixed-methods design [12], in which quantitative data collection and analysis preceded and informed the qualitative component. The survey examined CTU staff’s knowledge of, experience with, and training on PPIE, as well as actual practices and perceived needs. The qualitative component was developed based on the survey results and used to expand upon and provide depth of understanding of the survey findings, as well as to explore the organisational and operational context of PPIE support within CTUs.
The study team benefited from a grant from the Swiss Clinical Trial Organisation (SCTO, project number RoR2025_009) and the support of at least one CTU staff member from each CTU. It is reported according to the STROBE [13] and SRQR [14] guidelines.
Setting
The study was led by a team based at Geneva University Hospitals (HUG), which worked with the SPIRIT group composed of a CTU staff representative from each Swiss CTU. Meetings with the SPIRIT group were held online, three times during the implementation of the project. The group helped identify and provide access to the contact details of CTU staff, reviewed the protocol and the questionnaires and was kept informed throughout the project. The questionnaires were sent out from 16 April 2025 to 14 May 2025. The interviews were held from 25 June 2025 to 31 July 2025.
Participants
All staff members working in one of the nine participating Swiss CTUs (Basel, Bern, Geneva, Lausanne, Lugano, St Gallen, Zürich, ETH Zürich and Lucerne) were eligible (n = 289), regardless of their involvement in PPIE. Approaches to survey distribution differed across CTUs. While most CTUs shared staff contact details for direct emailing, Zürich and Bern preferred to implement an opt-in procedure to safeguard employees’ personal rights and privacy. Participation was voluntary.
Ten CTU staff members from 8 CTUs, identified through a dedicated survey item, were interviewed between June and July 2025. Although all CTU staff were invited to participate in interviews, as participation was voluntary, respondents who agreed to be interviewed were predominantly PPIE leads or their close collaborators.
Variables
The variables collected in the survey included: involvement in PPIE support (formal or informal), and self-reported knowledge, experience, training and confidence in advising researchers on PPIE. Questions on knowledge explored the staff’s general understanding regarding PPIE. Questions on experience explored the staff’s individual practical experience with PPIE in research. Questions on training examined the type of training followed by CTU staff.
Further variables included the actual practices in the CTU, including the frequency of PPIE support demand and type of support provided to researchers, the perceived adequacy between the support provided and the researchers’ expectations, and the perceived needs including training needs as well as the barriers and facilitators to PPIE implementation. For the qualitative component, outcomes consisted of themes related to the organisational integration of PPIE, conceptual understandings, barriers and enablers, and emerging challenges.
Data sources and measurements
A self-administered questionnaire was developed on REDCap software and hosted on secure institutional servers at HUG. The questionnaire was informed by existing literature on PPIE and the study objectives, and designed to capture key dimensions of PPIE support within CTUs. Although no formal validation was attempted, the questionnaire was pilot-tested by three CTU staff members (one each in Basel, Geneva, Zürich) to assess clarity, relevance and feasibility, after which minor adjustments were made accordingly. The final questionnaire included both closed and open-ended questions (file 1 of the appendix) covering: (1) respondent role and involvement in CTU activities, (2) involvement in PPIE support, (3) knowledge, experience and confidence in advising on PPIE, (4) support provided (practices), training and training needs, and (5) perceived barriers, facilitators and institutional needs related to PPIE implementation. The survey took approximately 10 minutes to complete.
The interview guide (file 2 of the appendix) was developed iteratively, informed by the survey results and covered: origins and implementation; current support provided by CTUs; views on training; views on PPIE; assessment of the participatory process; challenges; enablers and successes; and future perspectives, complemented by inductively emerging themes. One topic, tokenism [16], was introduced from the literature. The guide addressed the types of support offered, availability of internal resources (e.g. time, funding, staff), perceived institutional barriers, and examples of good practice. Interviews were conducted online via Microsoft Teams. For the Bern Department of Clinical Research (DCR), where scheduling was not possible, the interview guide was completed in writing and returned by email. Interviews were held in English or French, recorded with the consent of participants, and transcribed verbatim. Each lasted 60–70 minutes. Transcripts were stored securely on institutional servers. Relevant parts of transcripts were extracted.
Eight CTUs provided additional information on the number of CTU-supported projects and the share involving PPIE in 2023–2024, the year their PPIE activities began, the number of staff dedicated to PPIE, and the existence of patient databases or remuneration model.
Researcher reflexivity and bias
Two interviewers (MA and NE) contributed to data collection and analysis. The senior author (NE) is also an active PPIE actor at HUG (though not CTU staff) and may have influenced the interview of the Geneva staff. To mitigate this, the team held regular discussions to reflect on potential biases and ensure analytical rigour. The study was funded by the SCTO, a central coordinating body for CTUs in Switzerland. The SCTO had no role in the study design, data collection, analysis, interpretation of the data, or writing of the manuscript.
Study size
No estimation of required sample size was made, as this was a descriptive study with no aim to draw inferences or test hypotheses; we aimed to exhaustively contact all CTU staff members in Switzerland.
Quantitative data
Several questionnaire variables were recoded into broader analytical categories to improve interpretability and ensure sufficient subgroup sizes for comparison. These recategorisations concerned age, professional role, years of experience, familiarity with PPIE, knowledge and experience with PPIE, training, confidence in advising researchers, and frequency of PPIE support requests. Detailed recoding procedures are provided in table S1.1 in the appendix.
Data analysis
Quantitative survey data were analysed using Stata 18 (StataCorp, College Station, TX, USA). Analyses were descriptive. Counts and proportions are reported overall and stratified by CTU, distinguishing respondents with or without a PPIE support role. Missing data were reported for each item and not accounted for in the percentage calculation. Open-ended responses were categorised when enough responses were available.
Qualitative data were analysed thematically following Braun and Clarke’s approach [17, 18], without the use of dedicated qualitative data analysis software. This approach was chosen for its flexibility and suitability for identifying and reporting patterns across a heterogeneous dataset, in line with the descriptive and exploratory aims of the study. Interviews were conducted across 8 CTUs to capture the diversity of organisational contexts and approaches to PPIE support in Switzerland. Although recurring themes emerged, each interview contributed distinct perspectives and experiences. In addition, given the very small pool of PPIE-engaged staff in Switzerland, achieving thematic saturation was not feasible. Analysis followed the interview guide. The lead author read all transcripts multiple times and conducted an initial coding round to identify subthemes and illustrative verbatim quotes. A second round refined and consolidated subthemes across interviews. All codes and subthemes were reviewed by the senior author. The final synthesis grouped themes into four clusters: (1) organisational integration, (2) concepts, (3) barriers and enablers, and (4) emerging themes. Prevalent subthemes per cluster were selected for results presentation, supported by representative verbatim quotes. In addition, examples of original or repeatedly observed situations and practices were summarised.
Ethics approval
Upon request, swissethics confirmed that the study fell outside the scope of the Swiss Human Research Act [15] and therefore did not require their formal ethics approval (req-2025-00682).
Open science statement
The study protocol is publicly available on the Open Science Framework (OSF) (https://osf.io/dpn45/overview) and describes the overall SPIRIT project, including the present study (Part 1). No major deviations from the protocol occurred.
Results
Participants
The survey was distributed to 225 of the 289 (77.9%) identified CTU staff members across 9 CTUs; 139 responded, yielding a response rate of 61.8%. Response rates ranged from 28% (Zürich) to 87% (St Gallen) (figure 1). Ten respondents agreed to be interviewed; all were subsequently interviewed.
Descriptive data
Respondents were mostly women, aged 40 or older, with four or more years of CTU experience. Their expertise and primary roles (the role for which they were employed within the CTU) varied from methodology and statistics support to leadership and project management, reflecting the various profiles typically found in Swiss CTUs (table 1, appendix 3.1 and 3.2).
Table 1: Respondent characteristics. Percentages exclude missing data.
| Respondent characteristics | All respondents, n = 139 | PPIE-active staff, n = 56 | |
|---|---|---|---|
| Sex | Man | 36 (27.5%) | 15 (27.8%) |
| Woman | 83 (63.4%) | 34 (63.0%) | |
| Prefer not to say | 12 (9.2%) | 5 (9.3%) | |
| Missing data | 8 | 2 | |
| Age | Under 30 | 4 (3.3%) | 0 |
| 30–39 | 32 (26.2%) | 13 (26.0%) | |
| 40+ | 86 (70.5%) | 37 (74.0%) | |
| Missing data | 17 | 6 | |
| Experience within a CTU | <4 years | 45 (32.4%) | 15 (26.8%) |
| ≥4 years | 94 (67.6%) | 41 (73.2%) | |
| Primary role | CTU director & project management | 36 (26.7%) | 21 (38.2%) |
| Methodology, Statistics | 37 (27.4%) | 13 (23.6%) | |
| Clinical operations | 22 (16.3%) | 7 (12.7%) | |
| Regulatory, Quality & Safety | 15 (11.1%) | 2 (3.6%) | |
| Education/Teaching | 6 (4.4%) | 1 (1.8%) | |
| PPIE | 3 (2.2%) | 3 (5.5%) | |
| Support roles & other | 16 (11.9%) | 8 (14.5%) | |
| Missing data | 4 | 1 | |
CTU: Clinical Trial Unit; PPIE: Patient and Public Involvement and Engagement.
Main results
Fifty-six of the 139 respondents (40%) declared playing a role in PPIE support (formal or informal), of whom 3 (one each in Bern, Basel and Zürich) reported having PPIE as their primary role in the CTU. Twelve named PPIE as one of their domains of expertise (appendix 3.1). One quarter of CTU staff indicated having received training in PPIE (table 2, figure 2, appendix 3.3). Their training sources included internal CTU trainings (n = 7), a hospital-based course offered by Lausanne University Hospital (CHUV) and HUG (n = 7), SCTO online initiatives (n = 6), other online modules (n = 5), EUPATI courses (n = 4) and online trainings organised by the SNSF (n = 3). One respondent did not specify their training source.
Detailed results, by CTU, are provided in table 2.
Table 2: PPIE support within CTUs: an overview. Percentages exclude missing data.
| PPIE support | Basel | Bern | Geneva | Lausanne | Lugano | St Gallen | Zürich | ETH Zürich | Lucerne | Total | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| n = 34 | n = 17 | n = 17 | n = 24 | n = 9 | n = 13 | n = 14 | n = 6 | n = 5 | n = 139 | ||
| Primary role in PPIE | No | 32 (97.0%) | 15 (93.8%) | 17 (100.0%) | 23 (100.0%) | 9 (100.0%) | 13 (100.0%) | 12 (92.3%) | 6 (100.0%) | 5 (100.0%) | 132 (97.8%) |
| Yes | 1 (3.0%) | 1 (6.2%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (7.7%) | 0 (0.0%) | 0 (0.0%) | 3 (2.2%) | |
| Missing data | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 4 | |
| Advisory role on PPIE | Yes, formal role | 4 (12.5%) | 3 (17.6%) | 2 (11.8%) | 4 (18.2%) | 1 (11.1%) | 1 (7.7%) | 3 (21.4%) | 0 (0.0%) | 0 (0.0%) | 18 (13.3%) |
| Yes, informal help | 12 (37.5%) | 2 (11.8%) | 4 (23.5%) | 6 (27.3%) | 2 (22.2%) | 2 (15.4%) | 4 (28.6%) | 3 (50.0%) | 3 (60.0%) | 38 (28.1%) | |
| No involvement | 16 (50.0%) | 12 (70.6%) | 11 (64.7%) | 12 (54.5%) | 6 (66.7%) | 10 (76.9%) | 7 (50.0%) | 3 (50.0%) | 2 (40.0%) | 79 (58.5%) | |
| Missing data | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 4 | |
| Self-reported PPIE expertise | No | 32 (94.1%) | 15 (88.2%) | 16 (94.1%) | 20 (83.3%) | 9 (100.0%) | 13 (100.0%) | 12 (85.7%) | 5 (83.3%) | 5 (100.0%) | 127 (91.4%) |
| Yes | 2 (5.9%) | 2 (11.8%) | 1 (5.9%) | 4 (16.7%) | 0 (0.0%) | 0 (0.0%) | 2 (14.3%) | 1 (16.7%) | 0 (0.0%) | 12 (8.6%) | |
| Trained in PPIE | No | 25 (83.3%) | 13 (76.5%) | 13 (86.7%) | 15 (68.2%) | 8 (88.9%) | 11 (84.6%) | 5 (35.7%) | 5 (83.3%) | 2 (50.0%) | 97 (74.6%) |
| Yes | 5 (16.7%) | 4 (23.5%) | 2 (13.3%) | 7 (31.8%) | 1 (11.1%) | 2 (15.4%) | 9 (64.3%) | 1 (16.7%) | 2 (50.0%) | 33 (25.4%) | |
| Missing data | 4 | 0 | 2 | 2 | 0 | 0 | 0 | 0 | 1 | 9 | |
| PPIE support request frequency (n = 56) | At least once a week | 2 (12.5%) | 2 (40.0%) | 2 (33.3%) | 3 (30.0%) | 0 (0.0%) | 0 (0.0%) | 2 (28.6%) | 0 (0.0%) | 0 (0.0%) | 11 (19.6%) |
| Few/year or less | 14 (87.5%) | 3 (60.0%) | 4 (66.7%) | 7 (70.0%) | 3 (100.0%) | 3 (100.0%) | 5 (71.4%) | 3 (100.0%) | 3 (100.0%) | 45 (80.4%) | |
CTU: Clinical Trial Unit; PPIE: Patient and Public Involvement and Engagement; Primary role: main function for which the respondent is employed within the CTU; Advisory role on PPIE: providing support or advice to researchers on PPIE, either as part of a formal role or informally; PPIE expertise: self-reported, reflects whether respondents consider PPIE to be one of their domains of expertise; Trained in PPIE: any formal or informal training reported by respondents (e.g. courses, workshops or online modules).
Focus on 56 staff members providing PPIE support
Fifty-six participants reported being involved in PPIE support, whether this was part of their official role in the CTU (18; 32.1%) or not (38; 67.9%) (appendix 3.4, 3.5). Only 3 declared advising on PPIE at least once a week while 80.3% reported interacting with researchers only a few times per year or less (table 3, appendix 3.6).
When asked about their knowledge of PPIE, less than half reported having good knowledge. Two thirds reported having no or only limited experience with PPIE and less than one quarter reported being confident when advising researchers; 7 (12.7%) reported not being confident at all. The support provided to researchers included providing information on existing resources, budgeting and funding advice, and providing hands-on support for conducting PPIE activities (figure 3, appendix 3.7).
One third of the 56 respondents involved in PPIE support reported having received specific training in PPIE; 51.0% wished to be trained. The 56 respondents involved in PPIE support did not think a specific training was necessary (table 3).
Table 3: Focus on CTU staff providing PPIE advising within CTUs (n = 56). Percentages exclude missing data.
| CTU staff providing PPIE advising within CTUs | n (%) | |
| Advisory role on PPIE | Formal role | 18 (32.1%) |
| Informal help | 38 (67.9%) | |
| PPIE support request frequency | Weekly+ | 3 (5.4%) |
| Monthly+ | 8 (14.3%) | |
| Few/year | 25 (44.6%) | |
| Rare/never | 20 (35.7%) | |
| Trained in PPIE | Yes | 20 (37.7%) |
| No, but would like to receive a training | 27 (51.0%) | |
| No, and think it is not necessary | 6 (11.3%) | |
| Missing data | 3 | |
| Use of PPIE-related guidelines, frameworks or tools | Yes | 22 (40.0%) |
| No | 28 (50.9%) | |
| Unsure | 5 (9.1%) | |
| Missing data | 1 | |
| Source of PPIE experience | Current position | 40 (90.9%) |
| Previous position | 4 (9.1%) | |
| Missing data | 12 | |
| Self-reported familiarity | No familiarity | 0 (0%) |
| Moderately familiar | 21 (38.2%) | |
| Familiar | 34 (61.8%) | |
| Missing data | 1 | |
| Self-reported knowledge | No knowledge | 3 (5.5%) |
| Basic knowledge | 28 (50.9%) | |
| Good to expert knowledge | 24 (43.6%) | |
| Missing data | 1 | |
| Self-reported experience | No experience | 11 (20.0%) |
| Limited experience | 22 (40.0%) | |
| Moderate experience | 22 (40.0%) | |
| Missing data | 1 | |
| Self-reported confidence in advising | Not confident at all | 7 (12.7%) |
| Slightly confident | 35 (63.6%) | |
| Confident | 13 (23.6%) | |
| Missing data | 1 | |
CTU: Clinical Trial Unit; PPIE: Patient and Public Involvement and Engagement; Advisory role on PPIE: providing support or advice to researchers on PPIE, either formally or informally; PPIE support request frequency: how often respondents reported being contacted by researchers for PPIE-related support; Trained in PPIE: any formal or informal training reported by respondents (e.g. courses, workshops or online modules); Use of documentation: use of any guidelines, frameworks or tools to support PPIE activities; Position providing experience: whether respondents’ experience with PPIE was acquired in their current or previous role; Self-reported familiarity, knowledge, experience and confidence: based on respondents’ subjective assessment. Percentages are calculated on available data, excluding missing values.
The most frequently requested training topics are reported in figure 4.
Twenty-three of the staff invovled in PPIE support (48.9%) believed that the support offered met the researcher’s needs. When asked about additional types of support that would be relevant to provide, respondents selected a broad and balanced range of options with no single option clearly standing out (appendix 1, Q18), and none being rejected or considered irrelevant. Notably, only 3 respondents reported that no additional support needed to be offered (appendix 3.8).
To improve PPIE integration into clinical research, respondents most frequently cited the need for institutional recognition, a dedicated budget, clearer policies and dedicated staff. The importance of a strong umbrella organisation was mentioned by 26.8% of respondents. Barriers identified included low researcher awareness, lack of dedicated resources and absence of an institutional policy or strategy for PPIE (figure 5).
A detailed description of these results by CTU is available in file 3 of the appendix.
Qualitative study
Participants
In total, 10 staff members, 8 women and 2 men, from 8 CTUs provided qualitative insights; 9 were interviewed online and 1 provided a written response. The interviews were conducted with two representatives each for Lausanne and Basel CTUs. A selection of relevant verbatim transcripts is provided in file 4 of the appendix.
CTU characteristics
Table 4: An overview of the characteristics of the participating CTUs. The Lucerne CTU is not included as its PPIE activities started in 2025.
| CTU | Number of CTU- supported projects involving PPIE / all projects | Start of PPIE activities | Dedicated staff | Patient database for PPIE | PPIE remuneration model | |
|---|---|---|---|---|---|---|
| 2023 | 2024 | |||||
| Basel | 15/227 (6.6%) | 27/267 (10.1%) | 2020 | 1 role, part-time | Yes, expert patients only (not condition-specific) | Expert patients paid from project budgets (SCTO recommendations) |
| Bern | 6/138 (4.3%) | 8/109 (7.3%) | 2023 | 2 roles, part-time (PPIE support outside of CTU, but with the same department of clinical research) | Yes, public representatives, including patients (not condition-specific) | Public representatives paid from project budgets (SCTO recommendations) |
| Geneva | 12/404 (3.0%) | 6/349 (1.7%) | (2018) * | External group financially supported by the hospital, no formal position within CTU | Yes, coordinated externally; different levels of expertise and engagement | Patients paid from project and institution budgets (internal remuneration policy) |
| Lausanne | 5/206 (2.4%) | 14/226 (6.2%) | 2023 | 5 roles of which 3 employed by the CTU part-time; 1 project manager also 1 patient representative | Yes, different levels of expertise and engagement | Patients and staff paid from project budgets; internal remuneration policy |
| Lugano | 0/133 (0.0%) | 2/166 (1.2%) | 2023 | 1 role, part-time | No; relies on patient associations | Patient associations paid from project budgets |
| St Gallen | 0/119 (0.0%) | 0/106 (0.0%) | NA | 1 role, part-time | No | NA |
| Zürich | 18/550 (3.3%) | 12/617 (1.9%) | 2020 | 1 role, part-time | Yes, different levels of expertise and engagement | Patients paid from project and institution budgets (internal remuneration policy) |
| ETH Zürich | 1/15 (6.7%) | 2/25 (8.0%) | 2023 | 1 role, part-time; engaged in EUPATI and patient representative | No | No |
CTU: Clinical Trial Unit; NA: Not Applicable; PPIE: Patient and Public Involvement and Engagement; SCTO: Swiss Clinical Trial Organisation. In Geneva, PPIE support was provided through the PartnerREC network rather than within the CTU. Synthesis of the qualitative analysis
Organisational integration
The implementation of PPIE across CTUs originates from both institutional directives and individual initiatives. Formal or informal impulses from CTU leadership, such as encouragement from directors, or external funder requirements, like the SNSF calls for IICT proposals, have initiated PPIE activities through a soft top-down approach. As one participant illustrated: “The request came out of a discussion with (a director...). Researchers didn’t really know what to do with this whole PPI concept. And naturally, it was directed toward us (...).”
This institutional backing was often driven by motivated individuals whose personal commitment and expertise sustained and developed these initiatives. While such grassroots efforts (understood as actions emerging from individuals operating outside formal mandates) demonstrate important bottom-up energy, they expose PPIE activities to risks of discontinuity if not supported by institutional mandates or stable resource allocation. As another participant mentioned: “If I'm away, I really don't know if it would continue.”
Over time, some CTUs have begun developing internal resources such as patient databases (table 5, first row). In parallel, other structures to support PPIE have emerged, including the SCTO working group on PPIE, independent initiatives like PartnerREC in Geneva or PatientsLab in Lausanne, and networks of patient organisations. Yet, substantial variability persists in how CTUs formalise their support, with some having established structures and others lacking direct activities altogether.
Table 5: Original practices reported across CTUs.
| Patient databases | Implementation and content of patient databases varied across CTUs. Some databases include contributors without medical histories, leaving researchers responsible for condition-specific recruitment. One CTU invited patients and citizens to self-register via an online form, with no selection criteria. Other teams curate smaller lists of “research-expert patients”, though there is no shared definition of “research-expert”. Others rely on PPIE networks coordinated outside the CTU within institutions, outsource contact to patient associations or operate without any database at all. |
| Patient hiring | No CTU formally employs a patient as “patient-partner” in a dedicated PPIE role. In two exceptional cases, some staff combined professional expertise with lived experience; though recruited mainly for their professional qualifications, their partnership expertise may have influenced selection. One example involved a project manager who was a patient research-expert and was also active in a patient association. Another was a PPIE lead whose background as a patient was considered an asset, but not the decisive factor in the hiring decision. |
| Outsourcing patient perspectives | One CTU has no direct contact with patients and therefore outsources the collection of patient perspectives to patient associations. To do so, researchers develop questions regarding their study aims and design, which the associations, remunerated for their role, use to organise focus groups or interviews. The collected responses are then returned to the research team. |
| Matchmaking | To connect researchers and patients, one CTU organises “speed dating” style events. In these events, researchers present their projects in short sessions to different patient audiences, and patients get to listen to different research projects. Researchers receive immediate feedback from patients, and both can explore opportunities for collaboration. |
| The ambiguity of the patient expert | The contributions of patient partners range from sharing lived experience to co-leading research projects or shaping health policies. The Montreal Model classified these roles through different “levels of involvement” from consultation to genuine partnership [19]. Recent approaches have emphasised the recognition of patient knowledge as central to co-production, although the knowledge of what exactly is needed remains unclear. The status of patient expert remains debated by patients themselves. A Canadian survey of more than 600 patient partners [20] highlighted that for some, lived experience is sufficient to confer expertise, while others argue that additional training, skills or formal recognition are required. Some reject the label altogether, noting that their experience was not a chosen pursuit of knowledge but an imposed condition. In research, the meaning of patient expert is particularly ambiguous. For the EUPATI programme [21], it refers to patients trained in research methodology and regulatory processes, enabling them to act as informed interlocutors within clinical research teams. In contrast, Anglo-Saxon models often frame expertise less in terms of mastering research methodology but rather through skills such as communication, reflexivity or representation of diverse patient perspectives [22, 23]. |
Procedural challenges are frequent, particularly concerning remuneration models for patient partners, legal contracts and follow-up with researchers (table 5, second row).
Despite researchers receiving funding for PPIE activities, feedback loops to the CTU team are often lacking, limiting opportunities for continuous evaluation and improvement. “Very often (…), once they [the researchers] have this PPI plan and receive the funding, we usually don’t hear back from them.”
Concepts
Interviewees emphasised the intrinsic value of patients’ lived experience in making studies more relevant and meaningful. As a participant noted: “Research has to be patient-relevant. There’s no question about it. That’s why I think PPI should become the new normal. Patients should be included in every project, to make sure it really is meaningful for them. And to make sure we choose the right endpoints, the ones that matter to patients, not just to researchers.” Some expressed doubts about the genuine purpose and added value of PPIE, questioning whether it is a guiding principle or merely a procedural requirement linked to funding. One interviewee summarised this tension: “But do you know what’s harder for me to understand? It’s what the actual purpose is, what they’re trying to achieve. Is this just something we do to get funding, or is it supposed to be a real principle guiding the organisation?”
Tokenism, whether intentional or not, manifesting as superficial patient involvement with limited real influence, was acknowledged by participants as likely present, though not a primary concern. Participants rather highlighted how genuine patient partnership develops when researchers move towards intrinsic motivation, particularly when supported by evidence demonstrating PPIE’s positive impact. Evaluating the impact of PPIE on research outcomes and process was viewed as essential for learning and improving partnerships, though defining assessment methods remains challenging. Most agreed that demonstrating the real benefits of PPIE is more important than documenting procedural compliance.
Barriers and enablers
Perceived barriers to sustainable PPIE implementation included limited formal institutional support, unclear mandates and unstable resource allocation. Small teams, often managing competing priorities, faced capacity constraints that threatened the continuity and depth of PPIE activities. Unclear guidelines, fragmented coordination and complex administrative processes further complicated implementation.
A recurrent concern was the limited clarity of SNSF regarding what constitutes an acceptable PPIE plan, and how it is evaluated in grant reviews. This places CTUs in a challenging position, expected to advise researchers without established reference points. As one participant noted: “The SNSF does not provide clear examples of what they consider as a ‘good’ implementation of PPI and can hardly take into account the amount of resources needed to implement PPI.”
Interviewees reported that researchers’ ability to engage meaningfully with PPIE was another barrier, which they explained by both attitudes and practical issues such as heavy workloads, clinical duties and scarce resources. Many seek support only at the last minute, when meaningful involvement is difficult to achieve. Interviewees felt that perceptions of PPIE among researchers ranged from scepticism, seeing it as an administrative burden, to recognition of its concrete benefits, for example in outcome design and recruitment.
Despite these challenges, progress is evident. Networks are maturing and bringing together researchers, professionals and patients. In some cases, CTUs have responded creatively to capacity constraints (table 5, rows 3 and 4).
Participants emphasised the need for research and evaluation to demonstrate PPIE’s impact. Establishing centralised platforms to promote and coordinate PPIE evaluation nationally was highlighted as a strategic priority. As one participant noted: “But if you want to do research-on-research, it probably won't work if you only do it in one study (...) You would need something bigger, like a survey comparing lots of trials (...) led by SCTO or another central body. It’s hard to do on a single-study level.”
Showcasing success emerged as a critical enabler of awareness. Visible examples of effective PPIE, through accessible communication channels and informal interactions were seen as powerful ways to highlight benefits and motivate researchers towards PPIE. As one participant observed: “Researchers want to read: ‘Involving PPI in this way improved recruitment’ or ‘It improved the relevance of the endpoints’. If we can show that with evidence, they’ll be much more likely to engage.”
Emerging themes
Bias and conflicts of interest were recognised as issues affecting both patients and researchers. Although interviewees showed awareness of these risks, they believe these could be addressed through transparency, fairness in managing patient roles, clarifying expectations, rotating responsibilities, or ensuring that patient input is balanced.
The evolving identity of “patient experts” also raised concerns. Some were described as “super patients” blending both scientific and lived experience, which could bias authentic representation and induce academic insularity. As one participant noted: “I seriously wonder: do we really need patients to be experts to that extent? ... I really like the [research-]naïve patient side, which maybe corresponds more to your average Joe and Jane in the population. At least for many things, the naïve patient is almost more useful to us than the expert patient.” (table 5, fifth row)
Training was another recurrent theme. Embedding PPIE principles in medical and nursing curricula was seen as essential to foster awareness among future researchers and clinicians. Views diverged on how to train patients and CTU staff: some supported joint sessions to build mutual understanding, while others favoured separate tracks. A few warned against “over-training” patients, arguing that excessive professionalisation could dilute the value of lived experience. Some participants also recognised the importance of training researchers.
Communication challenges between researchers and patients further underscored the need for facilitation. PPIE experts were seen as mediators who could bridge gaps and help identify where patients might contribute most meaningfully. As one participant put it: “It’s difficult, sometimes, to know in which projects patients could really help or contribute meaningfully (…). Maybe that’s exactly where an expert could play an important role, as a moderator between the two.”
Capacity building also emerged as critical. Participants called for stronger infrastructures, including a clear training curriculum for CTU staff, better knowledge sharing, and more systematic evaluation of PPIE’s impact to consolidate efforts into coherent national practices.
Finally, practices around patient remuneration or compensation varied, reflecting different administrative approaches and highlighting the complexity of formalising compensation.
Discussion
Our findings show that PPIE support is a recent development in Switzerland, unevenly implemented and largely dependent on motivated individuals with some training but lacking experience. These results should be situated within international developments and considered through the lens of organisational readiness [24-26].
International development of PPIE
Countries with strong national structures have adopted PPIE earlier: the United Kingdom created INVOLVE in 1996 as a dedicated advisory body [27]; the United States followed with PCORI in 2010, mandating patient engagement in all funded projects [28], while Canada launched SPOR in 2011, building national networks and training programmes [29, 30]. National frameworks in the Netherlands and Australia have also promoted patient involvement in research since the 2000s [31-33].
In Scandinavia, with decentralised health systems and strong public-sector research, PPIE began to gain formal recognition during the early 2010s but remains variably institutionalised. A Nordic scoping review reports growing use of PPIE with heterogeneous terms, methods, and uneven evidence on management and impact, underscoring the need for clearer frameworks and “international agreement on terms and definitions” [34]. In Norway, a NorCRIN-linked national survey of researchers and PPIE contributors found broadly positive attitudes yet persistent gaps in time, budget, tools and role clarity, pointing to underuse in dissemination [35]. In Denmark, a case study highlights practical challenges around workload, insurance and honoraria, reflecting the relative novelty of PPIE and limited national guidance [36].
In low- and middle-income countries, engagement is often tied to community participation in disease-specific trials (e.g. HIV, TB), rather than research-based infrastructures [37, 38].
Switzerland: delayed uptake and the limits of incentive-based policies
In Switzerland, PPIE support within CTUs is still at an early stage, with fewer than 10% of all projects implementing PPIE in 2024, according to our findings. Most initiatives were launched only from 2021 onwards. One earlier exception is Geneva, where PPIE activities emerged in 2018 through a grassroots initiative developed outside CTU structures [39]. Adoption has been uneven, reflecting CTUs’ original mandate to provide methodological and regulatory expertise rather than participatory approaches [34], making PPIE both a cultural and structural shift.
The SCTO, founded in 2009 [40, 41], began to prioritise PPIE only in its 2021–2024 strategy. Overall, development has been mainly stimulated by SNSF IICT requirements, while emerging enablers such as patient databases, matchmaking events and outsourcing remain fragile without broader institutionalisation. Limited prioritisation at the institutional level means progress relies on motivated individuals and local initiatives to sustain PPIE.
While more than half of CTUs report providing theoretical support, only 25% of CTU staff reported being involved in hands-on PPIE activities (figure 3). This suggests that PPIE support in CTU mostly focuses on advice to researchers rather than concrete help in the engagement processes. This can be due to PPIE being developed as a response to a funding incentive, rather than as an institution-funded mandate. This illustrates a limitation of incentive-based policies: although they can stimulate awareness and local initiatives, they do not ensure the structural and human resources required for lasting implementation. This contrasts, for example, with Canada, where national or regional governments have rapidly funded dedicated PPIE coordinator roles resulting in more concrete implementation [28].
Fragility of support and organisational readiness
A key finding was the absence of dedicated PPIE roles and resources within Swiss CTUs, with most staff reporting limited to no experience, and low confidence in advising researchers. Reliance on motivated individuals risks discontinuity, as champions cannot compensate for absent institutional structures [24]. Limited expertise and training compound the problem.
This reflects low organisational readiness, defined as the collective commitment and capability of an institution to implement new practices [25, 26]. By contrast, UK CTUs employ dedicated PPIE managers and advisory panels; Canadian SPOR SUPPORT Units include engagement specialists who provide training and methodological support; and Australia’s Consumer and Community Involvement Program has built capacity through networks and tailored resources [42-45].
These examples highlight possible pathways for Switzerland. Meaningful integration of PPIE will require investment in organisational readiness, including dedicated CTU positions, research on PPIE methods, clear mandates, protected resources, systematic training and stronger national coordination. Embedding PPIE into training curricula for researchers and CTU staff would further reinforce readiness.
Our results confirm recent national observations showing that, although awareness and acceptance of PPIE are increasing in Switzerland, structural and financial support remain limited, with progress still reliant on local leadership and resources [46, 47].
Low visibility of patients in CTU teams
No CTU currently employs patients as “patient-partner” in their support teams or, when they do, they hire them as a scientific collaborator or project manager – which are not roles explicitly defined by their patient expertise. This is not unique to Switzerland. In the UK and Canada, patient partners are typically engaged through advisory, governance or project-based mechanisms rather than as salaried CTU staff [34, 45, 48-51]. The reasons for this remain unclear. It may reflect limited organisational readiness to accommodate new profiles within established research infrastructures, or hesitation among professionals to share leadership.
Conceptual ambiguity around “patient expertise”
Interviews highlighted an absence of a common understanding of what constitutes an appropriate patient profile for inclusion in research ranging from “research-naïve patients” to “expert patients” without clearly defining the term, others preferring the perspective of “hybrid” profiles. In the absence of agreed definitions, recruitment and evaluation of practices remain inconsistent, and remuneration policies difficult to harmonise. This echoes findings from a mapping review of HIV research, where differing levels of knowledge and expertise between PPI members and researchers emerged as common challenges [52].
Similar issues have been documented internationally. In the Nordic countries, reviews and surveys note heterogeneous terminology and a lack of consensus on expectations for user representatives [34]. In the Netherlands, role definitions are often negotiated project by project [33]. In the UK, blurred boundaries between “lay” and “expert” roles have been observed [53], although case studies also show that clearly defined roles can add tangible value [49]. In Canada, the SPOR programme explicitly emphasises the need for shared frameworks to guide role definition [29, 50], and several adaptations of the national SPOR framework have since been developed [54-56]. Evidence suggests, however, that while these resources are frequently cited, their use remains uneven, with many teams adapting them flexibly to local contexts [5, 30, 57].
This ambiguity may be intrinsic to the idea of partnership itself. Patients can be experts in living with a disease, experts in patient-partnership, they can master methodological, training or advocacy skills, and no single definition captures this diversity. Switzerland therefore mirrors a broader debate, and progress may lie less in imposing a single definition than in adopting flexible role descriptions, transparent recruitment and remuneration, and recognising both lay and expert contributions as complementary.
Limitations
Several limitations should be acknowledged. First, although we aimed to reach all CTU staff, confidentiality constraints prevented us from obtaining all email addresses, and only 62% of those contacted responded. It is possible that individuals more interested or involved in PPIE were more likely to respond, as suggested by the 40% of respondents reporting being involved in PPIE support, leading to an overrepresentation of PPIE-active staff and to an overestimation of the level of awareness, involvement and support for PPIE within CTUs. Second, the questionnaire was delivered by email, and we cannot be certain who completed it. However, invitations were sent to professional email accounts, which should have limited responses from non-concerned individuals. Third, inconsistencies were observed in some responses. For instance, multiple respondents within the same CTU reported being the “head of the unit”, raising questions about the reliability of certain items. Also, the lack of a standardised definition of expertise with regards to PPIE may have led to different interpretations. Fourth, the direct comparison of the proportion of supported projects including PPIE should be taken cautiously since the denominators were gathered unevenly across CTUs. Fifth, the interviews, although guided by a structured script, were flexibly conducted to allow participants to expand on issues of importance to them. Full thematic saturation was not reached due to the heterogeneity of PPIE practices across Swiss CTUs. Additionally, one of the interviewer’s own involvement in PPIE support (outside CTU) may have influenced the discussions. Finally, no patient participated in this part 1 of the SPIRIT project. This decision was made at the start of the project. To allow an initial mapping of institutional and professional viewpoints, patient participation was not deemed necessary; patients will collaborate in parts 2 and 3.
Conclusion
This first national study on how Swiss CTUs support PPIE highlights that support is recent, with only a few staff holding formal PPIE roles and most advice provided informally. Training and expertise are limited, and many respondents express low confidence in advising researchers. PPIE relies largely on motivated individuals and rarely on employed patients. These findings highlight important gaps in institutional support, resources, roles and conceptual clarity and calls for institutional mandates, dedicated budgets, protected staff positions and systematic training. Clarifying the role of patient partners while allowing flexible forms of contribution will be essential. Whether the PPIE support provided by the CTU aligns with researchers’ needs and expectations is unknown and will be the topic of SPIRIT part 2.
Data sharing statement
Custom analytical code and deidentified quantitative data underlying the findings of this study may be made available upon reasonable request to the corresponding author. Due to the qualitative nature of the study and the small number of participants within each CTU, full interview transcripts cannot be shared as they may contain potentially identifiable information. Selected deidentified excerpts are provided in the appendix. Additional study documents, including the questionnaire and the interview guide, are available in the appendix.