Patients active in research and dialogues for an improved generation of medicines: advancing meaningful patient engagement in the life cycle of medicines for better health outcomes


Start Date
End Date
IMI2 - Call 10
Grant agreement number

Type of Action: 
RIA (Research and Innovation Action)

IMI Funding
4 498 931
EFPIA in kind
4 601 344
Total Cost
9 100 278


There is growing recognition that patients can and should be more involved in the medicines development process. However, many stakeholders still have questions on how to put this principle into practice – who should be involved, how, and when? The PARADIGM project aims to provide a framework for structured, effective, meaningful and ethical patient engagement and demonstrate the ‘return on engagement’ for all stakeholders. Building on existing initiatives, the consortium will develop a comprehensive set of tools and practices to support the integration of patient perspectives into drug development and enhance trust among different stakeholders.

The project will focus on three decision-making points in the medicines development process: research and priority setting; clinical trial design; and early dialogues with regulators and health technology assessment (HTA) bodies. Ultimately, the team hopes that the project will help patient engagement to become a reality and standard practice, helping to improve research and deliver results that are focused on patients’ needs.

Achievements & News

PARADIGM: a ‘game changer’ for patient engagement in R and D
January 2020

There is now growing recognition that patients and their representatives can and should be involved in all stages of medicines development (R&D). But how do you do this in practice, and is it worth it? IMI’s PARADIGM project was set up in 2018 to create a framework for structured, effective, meaningful and ethical patient engagement, and to demonstrate the ‘return on engagement’ for all stakeholders.###

The project focuses on patient involvement in three key points in the medicines R&D process: research and priority setting; clinical trial design; and early dialogues with regulators and health technology assessment (HTA) bodies. So what have they delivered so far? With just months to go before the end of the project in August this year, the IMI Programme Office caught up with project coordinator Mathieu Boudes of the European Patients’ Forum (EPF).

‘PARADIGM is an atypical project – very short and most of the tangible achievements are due at the end of the project,’ explains Boudes. ‘We have robustly identified what is still very much needed by all actors involved in the development of medicines and that will make the most impact in terms of patient engagement. The consortium is currently developing a monitoring and evaluation framework for stakeholders who are doing patient engagement to help them measure the impact of their initiatives. It will be a game changer to bring patient engagement to the next level.’

Read more

Join the Patient Engagement Open Forum
July 2019

On 18-19 September, IMI projects PARADIGM and EUPATI are joining forces with Patient Focused Medicines Development (PFMD) to organise the Patient Engagement Open Forum in Brussels, Belgium. ###The aim of the event is to provide a holistic perspective of patient engagement, the landscape and actors, and foster collaboration and co-creation while breaking down fragmentation and silos that are often present in patient engagement work. The agenda offers a deep dive into some ongoing patient engagement work done by many collaborative initiatives. Topics range from tools and recommendations for effective patient engagement, methods for monitoring and evaluation of impact and outcomes in patient engagement activities, and fair market compensation for patient input to interactive sessions on assessing good practices in patient engagement and more. Registration is free but obligatory.

IMI patient engagement projects sign memorandum of understanding
November 2018

Two IMI projects focusing on patient engagement, PARADIGM and PREFER, have signed a memorandum of understanding (MoU) to enhance collaboration between the projects and to maximise results. The MoU outlines how the projects will work together and share ideas. ###While PARADIGM is broadly focused on patient engagement at three points in the research and development process, PREFER looks at how and when it is best to perform and include patient preferences in decision making during the medical product life cycle. Through the MoU, the two projects hope to identify areas of mutual interest; identify any gaps that are hindering progress; establish collaborative activities to address these gaps; and share knowledge and data. The projects will also mutually participate in project events and use each other’s communications channels to promote news and results. In a joint statement, the projects write: ‘There is an ample opportunity to leverage the work of these projects, to avoid duplicate efforts as well as maximise results.’

Participants Show participants on map

EFPIA companies
  • Alexion Services Europe SPRL, Brussels, Belgium
  • Amgen Limited, Cambridge, United Kingdom
  • Bayer Aktiengesellschaft, Leverkusen, Germany
  • Covance Laboratories LTD, Harrogate, United Kingdom
  • Eli Lilly and Company Limited, Basingstoke, United Kingdom
  • F. Hoffmann-La Roche AG, Basel, Switzerland
  • Federation Europeenne D'Associations Et D'Industries Pharmaceutiques, Brussels, Belgium
  • Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
  • Grunenthal GMBH, Aachen, Germany
  • H. Lundbeck As, Valby, Denmark
  • Institut De Recherches Internationales Servier, Suresnes, France
  • Janssen Pharmaceutica Nv, Beerse, Belgium
  • Merck Kommanditgesellschaft Auf Aktien, Darmstadt, Germany
  • Merck Sharp & Dohme Corp, Whitehouse Station, New Jersey, United States
  • Novartis Pharma AG, Basel, Switzerland
  • Novo Nordisk A/S, Bagsvaerd, Denmark
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
  • The Association Of The British Pharmaceutical Industry, London, United Kingdom
  • UCB Biopharma SRL, Brussels, Belgium
  • Verband Forschender Arzneimittelhersteller Ev, Berlin, Germany
Universities, research organisations, public bodies, non-profit groups
  • Agenzia Italiana Del Farmaco, Rome, Italy
  • European Forum For Good Clinical Practice, Brussels, Belgium
  • Fundacio Sant Joan De Deu, Esplugues de Llobregat, Spain
  • Health Technology Assessment International Society, Edmonton, Canada
  • Instituto Aragones De Ciencias De La Salud, Zaragoza, Spain
  • Stichting Vu, Amsterdam, Netherlands
  • University of Oxford, Oxford, United Kingdom
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Synapse Research Management Partners SL, Barcelona, Spain
  • The Synergist, Bruxelles, Belgium
Patient organisations
  • Alzheimer Europe, Luxembourg, Luxembourg
  • European Aids Treatment Group Ev, Duesseldorf, Germany
  • European Patients’ Forum (EPF), Brussels, Belgium
  • Eurordis - European Organisation For Rare Diseases Association, Paris, France
Project coordinator
Nicola Bedlington
Forum Europeen Des Patients (Fpe)
Project leader
Magda Chlebus