There is increasing consensus among stakeholders that patient engagement at different points of the medicines lifecycle is critical to fostering patient access to innovative therapeutic solutions, and delivering better health outcomes for patients.
Despite such development, patients continue to be a largely underutilised resource in medicines development. While there are many initiatives emerging to involve and engage with patients, inconsistency and fragmentation remain the norm. For key stakeholders, such as researchers/drug developers, regulatory authorities, HTA bodies (reimbursement agencies), pertinent and basic issues across all groups are: who should be involved, how and when.
This project intends to address the current situation by delivering:
Tools and practices
A set of comprehensive tools and practices, that build upon, and will align with, amongst others existing EUPATI and PFMD platforms, in order to support mainstreaming the integration of patient perspectives and experiences while enhancing mutual trust among the different stakeholders in the patient engagement process
Metrics for impact
Develop agreed patient engagement metrics with validated tools to increase evidence demonstrating the impact of patient engagement practices;
PARADIGM has a European scope and will focus on the following decision-making points in the medicines development process:
Promoting the adoption of practices by stakeholder groups by creating a ‘lowest common denominator’ of expectations for effective engagement.
Engagement capability, capacity building and sustainability: identifying specific resource needs and mobilisation potential for each stakeholder to further advance implementation of meaningful patient engagement practices across disease states and diverse patient groups;
Rules of engagement: developing resources to enable engagement (the “how to engage”) focusing on the three selected phases of the medicines life cycle and taking into account the particular needs of the selected vulnerable populations;
Ensuring strategic and extensive outreach to a broad set of stakeholders within the medicines development community at large and engage with relevant initiatives and projects to ensure optimal synergies and cross-fertilisation, while avoiding duplication of efforts;