Planning Patient Engagement
Raising awareness on managing competing interests in a multi-stakeholder environment: Guidance to patients and engaging stakeholders
Managing competing interests and conflicts of interest is of utmost importance when planning, considering and conducting patient engagement activities in medicines development (…)
Enhancement of the EUPATI industry guidance
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 (…)
Recommendations on required capabilities for patient engagement
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 (…)
Patient engagement agreements explained
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 (…)
Patient engagement in medicines development: Recommendations on how to find the right match for the right patient engagement activity
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
The code of conduct
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 (…)
Working with Community Advisory Boards: Guidance and tools for patient communities and pharmaceutical companies
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 (…)
Patient Engagement in Early Dialogues: Tools and resources for HTA bodies
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
Patient Engagement Monitoring and Evaluation Framework
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 (…)
Guidance for reporting and dissemination of patient engagement activities
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 (…)
