PARADIGM – Patients Active in Research and Dialogues for an Improved Generation of Medicines

Why?

There is increasing consensus among stakeholders that patient engagement at different points of the medicine’s 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.

Meaningful patient engagement brings mutual benefit to the community of medicine developers (meaning all stakeholders involved from the patients, industry, regulators, HTA bodies to the payers), and requires inputs into decision-making, co-production and dissemination of knowledge.

What?

The overarching mission of PARADIGM was to develop a framework that allows structured, meaningful, sustainable and ethical patient engagement throughout three key decision-making points of the development of medicinal products (prioritisation of research, early dialogue between regulators and HTA and design of clinical trials).

The framework included consensus-based recommendations on processes, tools (with the creation of templates) and methods to measure and demonstrate the added value of innovative and effective approaches to patient engagement.

Paradigm addressed the current situation by delivering:

• Tools and practices: a set of comprehensive tools and practices, that was built upon, and aligned 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: developed agreed patient engagement metrics with validated tools to increase evidence demonstrating the impact of patient engagement practices

With whom?

The consortium Is composed by 34 partners: 4 European patient organisations; 2 Competent authorities; 3 Academic teams; 1 Non-profit organisation; 2 SMEs; 1 Hospital; 21 Industry partners: 3 associations, 17 bio-pharmaceutical companies, 1 contract research organisation.

How?

EATG was co-leader of WP4 (Co-designed recommendations and resources for patient engagement) and involved in all the other work packages as well.

1. WP1: Defining stakeholders’ preferences, needs and expectations
2. WP2: Assessment of practices and processes
3. WP3: Development of metrics for monitoring and evaluation
4. WP4: Co-designed recommendations and resources for patient engagement
5. WP5: Dissemination and engagement
6. WP6: Sustainability strategy
7. WP7: Project Coordination and Management

For what outcome?

The main outcome of the PARADIGM project is the Patient Engagement Toolbox created under the co-leadership of EATG. The Patient Engagement toolbox centralises all PARADIGM’s co-created recommendations, tools and relevant background information to make patient engagement in medicines development easier for all. The material is organized under three layers:

1. Planning Patient Engagement
2. Conducting Patient Engagement
3. Reporting and Evaluation

Browse from the link below for the tools you might need, on the page of each tool you can find a version of the document in Russian:

https://imi-paradigm.eu/petoolbox/