Medicines research and development (R&D) is an increasingly complex process that remains a mystery for the majority of patients and the general public. Lifting the lid on the medical R&D process is the IMI-funded EUPATI project. EUPATI is a patient-led initiative that aims to develop the first European Patients’ Academy on Therapeutic Innovation, with training courses, educational material and an online public library that will empower patients to engage more effectively in the development and approval of new treatments and become true partners in pharmaceutical R&D.
While patients are keen to have access to better and safer treatments, many find it hard to understand the benefits and risks of novel therapies. With demand for healthcare rising, and a growing emphasis on both the quality and sustainability of healthcare services, it is critical to address this major gap in public perception and knowledge.
There is therefore a proven need for information resources, designed specifically for patients and the public, on how medicines R&D and clinical trials are conducted. This should cover diverse aspects of pharmaceutical research and innovation, including translationalresearch and personalised and predictive medicine, as well as the ways in which patients can support the research process and contribute to therapeutic breakthroughs. Well-informed patients are not only better placed to understand and make decisions about their treatments, but can also help to put patients’ needs at the heart of drug development, for example by joining scientific, ethical and regulatory committees and getting involved in clinical trial design.
Power to the patients
The Patients’ Academy will produce comprehensive, scientifically reliable and user-friendly information for patients on the of medicines development. It will increase the capacity and ability of well-informed patients and patients’ organisations to be effective advocates and advisors in medicines research. The patient-led consortium, which includes patients’ organisations, academic groups, non-governmental organisations (NGOs) and pharmaceutical companies, will generate educational resources in six key areas, namely the medicines development process; personalised medicine; drug safety and risk/benefit assessments; health economics and health technology assessment; clinical trials; and patients’ roles and responsibilities in medicines development. Material will be developed in English, French, German, Italian, Polish, Russian, and Spanish.
Objectivity, transparency and independence are essential if EUPATI is to achieve its goals. The project’s robust governance structure includes a multidisciplinary Project Advisory Board, a Regulatory Advisory Panel, and an Ethics Panel comprising renowned experts in bioethics, law, genetics, drug development, and patient advocacy, as well as representatives from regulatory authorities.
The project addresses three audiences. The ‘Expert Level’ will deliver a EUPATI Certificate Training Programme for patient experts, patient ambassadors and patient journalists. The accredited qualification will ensure that patients have the expertise and capacity to collaborate with all stakeholders involved in medicines R&D, wherever a strong patient voice is needed.
Advocacy leaders from patients’ organisations will be encouraged to access the ‘Education Level’ material in the EUPATI Toolbox. This will include a diverse range of cutting-edge resources such as e-learning courses, webinars, videos, slide shows for presentations, print material and face-to-face meetings.
Finally, all patients and the wider public will gain access to the EUPATI Internet Library, which will guide patients, including those with relatively low health literacy, through the complexities of the pharmaceutical R&D process.
Patients: industry’s partners in drug development
Involving patients in research can hugely benefit the drug development process; patients bring their own priorities and perspectives to the table and can offer fresh insights and challenge long-held beliefs, often resulting in entirely novel ideas and leading to better treatments for patients. Furthermore, greater patient involvement in R&D will boost the efficacy and safety of new treatments and raise public support for medical research.
Inducing a paradigm shift in patient involvement in medicines R&D
The Patients’ Academy is set to trigger a major rethink in the way patients and the public view the medicines development process and their own involvement in it. Armed with a deeper understanding of how the pharmaceutical sector works, patient experts and advocates will be empowered to work effectively with the relevant authorities, agencies, clinicians and industry to influence the drug development process for the benefit of patients.
Achievements & News
EUPATI publishes draft training programme syllabus
Patient education project EUPATI has published the first version of the syllabus for its high-level certificate training course. EUPATI aims to ###educate patients to enable them to play a stronger role in medicines research and development, for example by contributing to the work of research groups and ethics and regulatory committees. The new syllabus sets out the training programme for the EUPATI certificate training programme, a 12-18 month course featuring face-to-face and online learning. The course’s six modules cover all aspects of drug development, including clinical trials, regulatory affairs, safety, and health technology assessment. The syllabus benefited from input from diverse stakeholder groups, including patients, academics, ethics experts, industry, and teachers. The courses are expected to start in 2014 and are designed for 100 patient experts.
In addition to the certificate, EUPATI is developing an educational toolbox that patient advocates can download and use to learn about drug development, and an internet library that will provide patients with easy-to-understand information on drug development.
EUPATI event looks to the future of patient involvement in research
On 19 April 2013, IMI project EUPATI held a public conference in Rome, Italy on a vision for patient involvement in medicines research in 2020. ###The conference brought together 183 participants from 28 countries. It was structured around three key questions:
- What would patient involvement in medicines development look like in 2020?
- How can we build knowledge & competences for patients' involvement in medicines R&D?
- By 2020, what increase can EUPATI predict in public knowledge about development of new treatments?
IMI’s EUPATI project aims at providing patients with training and education opportunities to enable them to play a role in the medicines R&D process. The conference unveiled EUPATI’s ongoing plans for three areas of training and education: a certificate level course that by 2017 will produce 100 patient experts drawn from across Europe; more generic online education for 10 000 patient representatives; and an Internet library providing information to anyone with an interest in medicines R&D. Attendees heard that the broad outlines of the content of courses and material have been established, but finding the right way of teaching them will prove more of a challenge – as will be selecting 100 people from across Europe for the certificate level course. Even translation can be challenging; for example, some languages do not have a term for ‘randomisation’. Overall, the tone of the meeting was positive, with many speakers noting that there is now a real window of opportunity for effective patient involvement in R&D.
BIOVISION and the IMI Education & Training projects
IMI and the IMI Education & Training projects participated in BIOVISION - the World Life Sciences Forum, which was held in Lyon, France, on March 24-26 2013. It is the place where key stakeholders ###debate the impact of the latest scientific advances on society and share their vision on how to overcome health, environment and nutrition challenges. IMI Executive Director Michel Goldman participated in the plenary session ‘How to make better use of collective intelligence’. Mike Hardman, project coordinator of EMTRAIN, represented IMI and the IMI E&T projects in the BIOVISION Investor Conference workshop. Moreover, the IMI E&T projects organised a satellite event on ‘Training and Education in Europe’ where they presented their activities to the forum’s participants at a booth in the exhibition area.
IMI Education & Training projects in the spotlight at DIA EuroMeeting 2013
This year’s DIA EuroMeeting, which was held in Amsterdam, the Netherlands from 4 to 6 March, featured an entire theme dedicated to IMI’s five Education & Training (E&T) projects. The sessions featured ###the latest news from the projects and demonstrated how they are helping to advance education in the biomedical sector in Europe. DIA EuroMeeting visitors could also catch up with the projects and find out how IMI’s E&T projects can boost their careers.
- View the agenda for the IMI theme in the DIA EuroMeeting programme (page 46)
First EUPATI public workshop attracts over 100 participants
Over 100 people from 24 countries signed up to IMI Education & Training project EUPATI’s inaugural public workshop, which was held in Frankfurt, Germany in early September. ###The goal of the event was to gather feedback on the initial findings of the project, which aims to create a European Patients’ Academy on Therapeutic Innovation. ‘Nothing is set in stone,’ commented Project Coordinator Nicola Bedlington of the European Patients’ Forum. ‘We have a framework and clear ideas, but the input of all participants, being experts with different backgrounds and form different geographical areas, is absolutely vital to shape what we do. The floor is open.’ Items on the agenda in Frankfurt included how to raise awareness of EUPATI, how to establish national platforms, how to enhance the collection of information, and how to ensure that as many patients as possible benefit from the information generated by EUPATI. A full report of the workshop, as well as photos and webstreams from the workshops, are available from the project website.
Join the EUPATI Network
EUPATI (the European Patients’ Academy on Therapeutic Innovation) is inviting people to join the newly-created EUPATI Network. ###Open to patients and patient organisations, caregivers, academia, pharmaceutical & biotech companies, journalists, and anyone else interested in finding information on medicine research & development in lay language, the network offers members a number of benefits. In addition to information on EUPATI activities, events and networking opportunities, network members will also receive invitations to participate in EUPATI surveys or focus groups and will have the opportunity to collaborate with other network members, for example on the organisation of national events. Membership of the EUPATI Network is free of charge.
- European Patients’ Forum (EPF), Luxembourg
- European AIDS Treatment Group (EATG), Düsseldorf, Germany
- European Genetic Alliances Network (EGAN), Brussels, Belgium
- European Organisation for Rare Diseases (EURORDIS), Paris, France
EFPIA member companies
- Amgen Belgium SA/NV, Brussels, Belgium
- AstraZeneca AB, Södertälje, Sweden
- Bayer Pharma AG, Berlin, Germany
- Boehringer Ingelheim International GmbH, Ingelheim, Germany
- Chiesi Farmaceutici SpA, Parma, Italy
- Eli Lilly and Company Ltd, Basingstoke, UK
- F. Hoffmann-La Roche Ltd, Basel, Switzerland
- Farmaindustria, Madrid, Spain
- GlaxoSmithKline R&D Ltd, Middlesex, UK
- Janssen Pharmaceutica NV, Beerse, Belgium
- Laboratorios del Dr Esteve, SA, Barcelona, Spain
- Merck KGaA, Darmstadt, Germany
- Novartis Pharma AG, Basel, Switzerland
- Novo Nordisk A/S, Bagsvaerd, Denmark
- Sanofi Aventis R&D, Chilly-Mazarin, France
- UCB Pharma SA, Brussels, Belgium
- Verband forschender Artzneimittelhersteller eV, Berlin, Germany
Universities, research organisations, public bodies, non-profit groups
- Biopeople / Copenhagen University, Denmark
- DIA Europe GmbH, Basel, Switzerland
- European Forum for Good Clinical Practice, Brussels, Belgium
- European Organisation for Research and Treatment of Cancer, Brussels, Belgium
- Hibernia College, Dublin, Ireland
- International Society for Pharmacoeconomics and Outcomes Research Inc., New Jersey, US
- Irish Platform for Patients' Organisations, Science and Industry, Rathmines, Ireland
- Nowgen / University of Manchester, Manchester, UK
Facts & Figures
|IMI funding||5 300 000|
|EFPIA in kind||4 800 000|
|Total cost||10 100 000|
Tel: +49 89 66086968
Project Coordinator & Managing Entity
European Patients’ Forum
Tel: +32 2 280 2334
Verband forschender Artzneimittelhersteller
Tel: +49 30 2060 4143