PARADIGM Patient Engagement Toolbox

This toolbox centralises all PARADIGM’s co-created recommendations, tools and relevant background information to make patient engagement in medicines development easier for all. Browse from the sections below for the tools you might need, hover over to see a quick preview and click on the tool to access all related resources. Let us know how you’ve used these tools, we’d love to know how they’ve helped you in your patient engagement activities!

Planning Patient Engagement

Managing competing interests and conflicts of interest is of utmost importance when planning, considering and conducting patient engagement activities in medicines development (…)

During the PARADIGM project further expansion of specific sections of the EUPATI Guidance for Patient Involvement in Medicines Research and Development (R&D); Guidance for Pharmaceutical Industry-Led Medicines R&D guidance were required (…)

This tool provides recommendations on the competencies (understood as knowledge, skills and behaviours) and resources that each stakeholder organisation should aspire to have in place in order to plan, implement and evaluate meaningful and sustainable patient engagement (PE) activities across the medicines lifecycle (…)

PARADIGM has created this Patient Engagement Agreements Explained- tool to enable the suitability and usability of the co-created Guiding Principles and the four reference agreements – a project led by the pan-European cancer patients’ network through WECAN/MPE and partnered with PFMD – for all stakeholders (…)

During the analysis of existing practices and processes of patient engagement in the context of the PARADIGM project, a clear gap was identified under the theme ‘Selection of participants and adequate representation’. This related to a description of the steps followed to identify patient representatives between the engaging partners (…)

Conducting Patient Engagement

There is no European or international legislation defining the rules for patient engagement in medicines’ lifecycle activities. Guidelines and recommendations exist covering different aspects and conditions of the collaboration between patients, sponsors, ethics committees, competent authorities or HTA bodies (…)

Community Advisory Boards (CABs) can improve research by providing direct and independent advice from the community of patients about different aspects of a clinical trial in ways that are more inclusive from the perspective of patients. Setting up and running a CAB requires careful planning, organisation, follow-up, monitoring and evaluation (…)

Early Dialogues with regulators and health technology assessment (HTA) bodies are a well-established processes in which medicines developers have the opportunity to discuss their research plans and gain advice and feedback on their planned approach (…)

Reporting and Evaluation

Capturing the ‘return on engagement’ is complex, given the many factors that influence the impact of patient engagement. This Patient Engagement Monitoring and Evaluation Framework, with metrics, was created to help partnerships between patients and/or patient organisations, bio-pharmaceutical companies, regulators and (…)

The complete and reliable reporting and dissemination of all patient engagement (PE) activities is essential to ensure transparency and enable continuous broad learning for all relevant stakeholders undertaking PE (…)