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Patients Active in Research And Dialogues for an Improved Generation of Medicines (PARADIGM) is a large public-private partnership and is co-led by the European Patients’ Forum and European Federation of Pharmaceutical Industries and Associations (EFPIA). The consortium has a European focus with a global outlook consisting of 32 partner organisations that include; the pharmaceutical industry, patients and patient organsiations, academic institutions, regulators, and health technology assessment (HTA) bodies.

Aims

PARADIGM’s mission is to provide a unique framework that enables structured, effective, meaningful, ethical, innovative, and sustainable patient engagement and demonstrates the ‘return on the engagement’ for all major stakeholders involved in the medicines’ development continuum.

Why is it important?

There is increasing consensus among stakeholders that patient engagement (patient and public involvement (PPI) in the UK) 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? These basic issues are often amplified in vulnerable populations (such as people with dementia and their carers, and young people) where patient engagement barriers are poorly understood and in many cases enabling mechanisms are missing entirely.


Through maximizing synergies with other initiatives focusing on the patients’ voice in the lifecycle of medicines such as Patient Focused Medicines Development (PFMD) and European Patient Academy on Therapeutic Innovation (EUPATI), the objective of PARADIGM is to develop much needed processes and tools for three key decision-making points: 

 

 

Research priority setting

i.e. providing opinion, providing evidence and/or being part of a group that decides what is important to research

Design of clinical trials

i.e. designing protocols, discussing patient burden, discussing patient-related outcomes

Early dialogues with regulators and Health Technology Assessment bodies

i.e. early (multi-stakeholder) discussions between industry, HTA agencies and regulators (and in some contexts with payers) to discuss developmental plans for a medicinal product and to ensure they meet the requirements.

 

Within this context the consortium uses a co-creation approach to understanding, elucidating and addressing several key elements of patient engagement;

Needs and expectations: Strengthen the understanding of stakeholders’ needs and expectations for engagement (including underrepresented and vulnerable populations) and create agree minimum criteria for effective patient engagement;

 

Gap analysis of practices: Develop an inventory of where, when and how the agreed criteria are lacking or missing entirely, to inform the development of a tool box of supportive processes, guidance and templates that address the identified gaps.

 

Sustainability roadmap: Develop an inventive and workable sustainability roadmap to optimise patient engagement in key decision-making points across medicines’ R&D;

 

Agreed metrics: Develop agreed patient engagement metrics to increase evidence demonstrating the impact of patient engagement practices;

 

Systems-readiness: Strengthen system readiness towards patient engagement across the diverse range of stakeholders that develop, regulate and assess medicines.

PARADIGM Team