Patient and Public Engagement in Clinical Trials: CTO’s Decade of Co‑production Lessons

Background and rationale for patient and public engagement at CTO

Clinical Trials Ontario (CTO) is a not‑for‑profit organization established to improve the environment for clinical trials rather than to conduct them. Since its inception in 2014, CTO has intentionally involved patient and public partners as active contributors to organizational work. The organization uses the term patient and public engagement (PPE) to describe efforts that move partners beyond the role of research participant to team members who help shape initiatives and products.

This approach recognizes that mechanisms such as project‑level reporting tools (for example, GRIPP2) document PPE for individual studies, but fewer accounts exist of how organizations collaborate with patient and public partners across programs and operations. CTO’s experience provides an example of PPE applied at an organizational level under a strategic pillar devoted to engagement.

Co‑production model and methods used for engagement

CTO and its patient and public partners adopted a co‑production model to design and execute engagement processes. Team members and partner representatives worked together to co‑develop procedures that would guide participation across CTO’s Engage strategic pillar. The co‑production approach emphasized shared responsibility for setting agendas, contributing to products, and evaluating outcomes.

Processes were developed iteratively: engagement workflows, expectations for partners, and roles within projects were refined through ongoing collaboration between CTO staff and partners. The description indicates that CTO intentionally embedded partners into project teams rather than treating input as occasional consultation.

Use of the Patient and Public Engagement Evaluation Tool

To monitor and align engagement practice with co‑production aims, CTO used the Patient and Public Engagement Evaluation Tool. This evaluation instrument collected feedback and insights after engagements, which informed iterative changes to CTO’s PPE processes.

The use of a structured evaluation tool allowed CTO to identify areas for improvement and to adjust engagement formats, frequency, and membership to better meet the needs of both the organization and partners. Details of specific metrics or scores reported from this tool were not provided in the source.

Evolution from advisory group to the College of Lived Experience

CTO’s PPE activities began with a small patient and public advisory group that met quarterly in person. That group provided guidance on specific products such as CTO’s website about clinical trials and a clinical trial finder.

Over time, and informed by lessons learned about participation and capabilities, CTO expanded the advisory group into the College of Lived Experience. This larger body includes a broader range of perspectives, meets more frequently, and shifted predominantly to virtual meetings. The College was formed just before the COVID‑19 pandemic was declared, which coincided with increased virtual engagement.

Members of the College have been embedded in a variety of CTO projects and are available to provide input both within CTO and to external initiatives. The evolution reflects deliberate changes in membership breadth, meeting cadence, and modality to increase inclusion and operational contribution.

Outputs, contributions, and examples of impact

Working with the College of Lived Experience produced several tangible outcomes:

• College members were embedded across multiple CTO projects, contributing to product development and operational activities.
• Public‑facing outputs were generated with partner input, including improvements to the CTO website and tools such as the clinical trial finder.
• The College generated a research idea that led to a project culminating in a peer‑reviewed publication co‑authored by a patient partner.
• The College has offered insights and input on projects beyond CTO, indicating the group’s utility as a resource for the broader clinical trials ecosystem.

Specific templates, outputs, or the publication citation were not included in the source text; CTO reports that these materials are provided as part of sharing their work but details were not reported in the source summary.

Lessons learned from CTO and College members

CTO shares lessons learned from both organizational and College member perspectives. Key themes reported include:

• The importance of adapting engagement structures to partners’ abilities and preferences, for example by moving to more frequent, virtual meetings to increase accessibility.
• Embedding patient and public partners into projects delivers practical benefits, including better product relevance and generation of research priorities that matter to lived‑experience stakeholders.
• Using an evaluation tool supports iterative improvement and helps keep co‑production efforts on track.

The source provides an overview of these lessons but does not enumerate a formal checklist or all specific operational templates in the summary.

Conclusions and resources shared for other organizations

CTO concludes that its decade of PPE activity supports a co‑production model that is central to the Engage strategic pillar and applicable across organizational functions. By providing templates, outputs, and lessons learned, CTO aims to assist other clinical trials organizations internationally in integrating patient and public engagement into operational efforts.

The source emphasizes practical evolution—expanded membership, virtual meeting formats, embedded roles, and use of an evaluation tool—as core components that other organizations can adapt. Specific materials and templates are noted as shared by CTO, but the source summary did not reproduce those documents or their contents.