PARADIGM Patient Engagement Toolbox

The PARADIGM Patient Engagement Toolbox brings together the main outputs of the IMI‑PARADIGM project to support structured patient engagement across the medicines development lifecycle. Material is organised into three sections that mirror key stages of engagement: Planning Patient Engagement, Conducting Patient Engagement, and Reporting and Evaluation.

• Planning Patient Engagement includes guidance and tools on managing competing or conflicting interests, recommendations on required capabilities, explanations of patient engagement agreements, and advice on matching activities with appropriate patient participants. 
• Conducting Patient Engagement provides a code of conduct for patient engagement in the medicines lifecycle, guidance on working with Community Advisory Boards, and tools to support early dialogues with regulators and HTA bodies.
• Reporting and Evaluation offers a Patient Engagement Monitoring and Evaluation Framework with metrics to assess “return on engagement”, as well as guidance, checklists and templates for reporting and disseminating patient engagement activities.

Types of material include concise guidance documents (code of conduct, early dialogue guidance, reporting and dissemination guidance), checklists and templates (monitoring and evaluation framework, reporting template, log‑of‑activities, contract templates), and practical background documents explaining how recommendations were developed and how they can be adapted in different organisational settings.

Investigators can use the toolbox to plan patient engagement in clinical trials (clarifying roles, managing competing interests, defining required skills, and identifying appropriate patient partners), to support ethical and transparent collaboration with patient communities, regulators and HTA bodies during trial design and conduct, and to document, measure and report the impact of patient engagement in publications, reports and HTA submissions.

The toolbox offers a comprehensive, co‑created set of patient engagement tools tailored to medicines research & development, helps investigator‑initiated studies embed meaningful patient involvement across planning, conduct and reporting, and provides ready‑to‑use templates and frameworks that can be adapted in academic or hospital‑based research without developing new tools from scratch.