In the health research space, it is becoming more common to see patient and public partners as members of teams and contributing to various initiatives rather than solely as participants in research. We use the term patient and public engagement (PPE) to describe this approach. While reporting mechanisms such as the Guidance for Reporting Involvement of Patients and the Public, Version 2 (GRIPP2), are being used to share teams’ PPE efforts related to specific research projects, to date we have seen less about how organisations have collaborated with patient and public partners on a broader scale. Clinical Trials Ontario (CTO) is a not-for-profit organisation in the clinical trials space that has been set up to improve the environment for trials rather than conduct trials. We share CTO’s PPE processes, how they have evolved over the past decade, outputs related to this work, and lessons learned.

Patient and public partners and team members from CTO used a co-production model. We have co-developed PPE processes to guide and carry out the work under CTO’s strategic pillar of Engage. The Patient and Public Engagement Evaluation Tool has played a role in helping ensure CTO’s approaches to co-production are on track. Feedback and insights provided in the evaluation tool after engagements have resulted in iterative changes to this work.

CTO has engaged patient and public partners in its work since its inception in 2014. Gradually, this work has evolved based on both the needs of CTO and the patient and public partners with whom it collaborates. Originally, a small group called the patient and public advisory group was created, which met quarterly in person and provided guidance related to specific products (eg, CTO’s website about clinical trials, a clinical trial finder). Based on lessons learned with that group and the abilities of people to participate, the group was expanded to become CTO’s College of Lived Experience. The College of Lived Experience includes more perspectives and meets more frequently and predominantly virtually, having been formed just before the COVID-19 pandemic was declared. Working with the College has resulted in: members being embedded in a range of CTO projects, a number of public-facing outputs and generating a research idea and carrying out a project that resulted in a patient partner co-authored, peer-reviewed publication. The College is also available to and has provided input and insights into projects and initiatives outside of CTO. We share lessons learned from organisational perspectives and from those College members who are co-authors of this work.

CTO’s work in PPE has resulted in a co-production model that is critical to efforts in CTO’s Engage strategic pillar and beyond. We provide templates and outputs of this co-production work and lessons learned. We hope our work helps other clinical trials organisations across the globe to include patient and public partners in their operational efforts.

Equity, diversity and inclusion (EDI), patient engagement and shared decision-making are important considerations throughout clinical trials, including the research ethics review stage. Meaningfully integrating these considerations can enhance the relevance and generalisability of trial results and reduce participation barriers among equity-deserving populations. Presently, it is unclear to what extent such guidance is provided at the ethics application stage for clinical trials. This study aimed to report the degree of guidance on EDI, patient engagement and shared decision-making in clinical trial research ethics documents.

This was an embedded mixed methods study conducted in collaboration with Clinical Trials Ontario.

This study analysed research ethics board (REB) forms and templates from 17 institutions across seven provinces in Canada.

15 REB application forms, 9 protocol templates and 17 informed consent document (ICD) templates were assessed for guidance related to EDI, patient engagement and shared decision-making. The Place of residence, Race, ethnicity, culture and language, Occupation, Gender and sex, Religion, Education, Socio-economic status, Social capital (PROGRESS)-Plus framework, International Association for Public Participation Spectrum of Public Participation, Patient-Oriented Research Level of Engagement Tool, Indigenous Research Level of Engagement Tool and shared decision-making standards guided our coding. We engaged with patients and persons with lived experience to inform interpretation, reporting and dissemination.

EDI guidance from 15 ethics application forms and 9 protocol templates predominantly covered the ‘Race, ethnicity, culture, language’ (n=14; 93.3%), ‘Age’ (n=13; 86.7%) and ‘Gender and sex’ (n=12; 80%) categories of PROGRESS-Plus but lacked nuance on diverse gender identities (n=1; 6.7%). Patient engagement guidance mostly covered the ‘inform’ level (n=7; 46.7%) and applying ‘knowledge in practice’ with non-Indigenous (n=7; 46.7%) or Indigenous communities (n=13; 86.7%). All 17 (100%) ICD templates included guidance on information about options, disclosures, key elements, ethical issues and study design. No guidance was available on time-dependent relationships, empowering patients and communities in co-leading trials or providing structured guidance in making trial participation decisions (all n=0; 0%).

We provided a comprehensive view of EDI, patient engagement and shared decision-making guidance in trial ethics applications in Canada. REB guidance may be strengthened in several areas to support the inclusion of equity-deserving populations in trials, meaningful engagement with patients and Indigenous communities and evidence-informed, values-aligned decisions about trial participation.