A new digital tool aims to help the patient community to understand the agreements they might need to review when collaborating with pharma, says The Synergist’s Chi Pakarinen and Julia Tolley of Myeloma Patients Europe
A new Code of Conduct for all stakeholders involved in patient engagement will facilitate trust and meaningful collaboration, say Ingrid Klingmann of EFGCP, Karina Huberman of the European Aids Treatment Group, and Wolf R See of BayerRead More
Neil Bertelsen of the HTAi Patient and Citizen Involvement in HTA Interest Group (PCIG), outlines why tools and resources to encourage patient involvement in HTA Early Dialogue processes with patients are essential Read More
Dr Stuart Faulkner, Programme and Operations Manager, Department of Primary Healthcare at Oxford University, and Dr Ana Diaz, project officer with Alzheimer Europe, explain the process behind developing a tool that offers much-needed guidance on the reporting and dissemination of patient engagement activitiesRead More
Leader of the PARADIGM consortium Mathieu Boudes from the European Patients’ Forum (EPF) and Senior Director, Patient Engagement at GlaxoSmithKline, Kay Warner outline the genesis of the PARADIGM tool they led the co-creation of: “Recommendations on how to find the right match for the right patient engagement activity”Read More
Giorgio Barbareschi from the European AIDS Treatment Group, Ana Diaz from Alzheimer Europe, Manuela Bruegger of Novartis and Daniel De Schryver of Janssen explaining how they devised a set of tools that would encourage patient groups and pharmaceutical companies to engage in community advisory boardsRead More
What happens in patient engagement when everyone is not on the same page? Elisa Ferrer and Maria Cavaller of Eurordis describe how they devised tools for the management of competing interests and conflicts of interestRead More
Elisa Ferrer of EURORDIS and Karina Huberman of the European Aids Treatment Group (EATG) explain why they went back to basics to devise a tool outlining recommendations on the required capabilities for patient engagement Read More
Lidewij Vat and Tjerk Jan Schuitmaker of Vrije Universiteit Amsterdam, along with Paul Robinson of MSD discuss how they worked to co-create a monitoring and evaluation framework that could meet the needs of all stakeholders involved in patient engagement
Enhancement of the EUPATI industry guidance was necessary as patient engagement activities continue to evolve, explain GSK’s Kay Warner, Wolf R See of Bayer, and Ingrid Klingmann of EFGCPRead More
On May 12th, PARADIGM organised 3 parallel workshops online, aimed to provide the opportunity for participants from the CEE countries to give feedback and shape the thinking about the patient engagement tools that PARADIGM is currently developing to support sustainable patient engagement across the board. This resulted in the recognition from the PARADIGM consortium that for the tools to have a global impact, the insights coming from regions where the patient engagement ecosystem might be less mature are very much needed.Read More
Lisa Power, a consultant with the European Aids Treatment Group, explores how European organisations can support wider geographical diversity in patient engagementRead More
Maarten Kraaijenhagen, Senior Medical Director Rare Disease with Pfizer and PARADIGM member interviews Marzena Nelken, board member of the EPF and Project Manager with the Federation of Polish PatientsRead More
Dr Stuart Faulkner and Laiba Hussain, Oxford University
On Feb 21st 2020, Work package 2 (WP2) held an interactive webinar to disseminate the final results of the identification and analyses of gaps in patient engagement (PE) practises and processes. It offered a unique chance to understand how identifying tangible gaps in PE can inform actionable outcomes in the development of tools, templates, and frameworks for improved patient engagement.Read More
Initial efforts to commence patient engagement initiatives across Novartis were greeted with both enthusiasm and scepticism, writes David Parrish, Patient Engagement Early Research and Dr Francesco Patalano, Head of Center of Excellence, Patient-Reported Outcomes at Novartis, and Laura McKeaveney, Global Head of Patient Advocacy with the Novartis Group.Read More
Patient and care-giver input into a Duchennes muscular dystrophy clinical trial had positive outcomes, explain Katherine Beaverson, Senior Director and Patient Advocacy Lead Rare Disease Research Unit, Pfizer and Maarten Kraaijenhagen, Senior Medical Director Rare Disease, Pfizer and PARADIGM memberRead More
The path to patient engagement does not always run smoothly. Michelle Mujoomdar, director of scientific affairs, Canadian Agency for Drugs and Technologies in Health (CADTH), outlines how the agency has learned from its endeavours in this areaRead More
Training patients in PE has resulted in many successes, but there have also been missed opportunities, writes Traceann Rose, Program Director at the Children’s Tumor FoundationRead More
Authors: Zsófia Bakonyi, Camilla Baouchi Habre and Chi Pakarinen (PARADIGM team)
As part of a new online series, PARADIGM sought to explore the many angles of patient engagement in real life, by looking at learnings from six different stakeholder organisations Read More
Authors: Dr Sheuli Porkess & Dr Jennifer Harris
Patient and public involvement must be embedded at a system-wide level throughout the health and research landscape – across government, industry, charity and academic sectors. Read More
Authors: Tjerk Jan Schuitmaker, Assistant Professor System Innovations in Health Care at Athena Institute (VU) and Paul Robinson, European Lead, Patient Innovation at MSD.
Metrics are good but what makes them both meaningful and feasible when it comes to Patient Engagement (PE)? A session at the PE Open Forum explored this questionRead More
Improving the multi-stakeholder framework for patient engagement (PE) was the goal of the final session of the PE Open Forum 2019
Hosted by Ingrid Klingmann of EFGCP, Karina Huberman and Giorgio Barbareschi of EATG, the final break-out session of the Open Forum aimed to raise awareness regarding relevant materials already under development and to foster collaboration for future co-creation of the next generation of patient engagement tools. Read More
Workshop highlights the challenge of drafting contracts for patient-pharma collaboration but aims to make co-created legal agreements the norm.Read More
The lack of a transparent and consistent system in place for financial compensation that reflects the level of individual contribution and expertise of patient partners is finally being addressed, heard the Patient Engagement (PE) Open ForumRead More
An interactive workshop at the Patient Engagement (PE) Open Forum offered a chance to hear how patient engagement works in practice. Read More
Luca Li Bassi, Director General at the Italian Medicines Agency (AIFA), says it is a privileged perspective for regulators to better shape the decisional processes on medicines
Professor Faiez Zannad
Faiez Zannad is Professor of Therapeutics and Cardiology at the Centre d’Investigation Clinique Inserm and Université de Lorraine, CHU Nancy, France, and founder of the Global CardioVascular Clinical Trialists (CVCT)Read More
Metrics to determine the shared value of patient engagement will be the focus of Session 6 on Day 2 of the Open Forum, which will be led by representatives from VU-Athena, MSD and EURORDIS.Read More
Author: Lisa Power, consultant EATG
Community Advisory Boards, both in-country and Europe-wide, are a feature of patient engagement (PE) in the R&D process for a growing number of health conditions. Patient advocates from across Europe meet with companies and researchers to inform the drug development pathway about real-life impacts and improve information flow to their communities. The European AIDS Treatment Group (EATG)’s European Community Advisory Board (ECAB) has been working for over two decades now on HIV and, more recently, drug development and access issues for viral hepatitis and tuberculosis. I spoke to members of the ECAB, as well as the Scientific Officer about their experiences from the early days when anyone could attend the ECAB to the current, more systematic and orderly structure.Read More
A two-part session taking place over both days of the Open Forum will endeavour to understand and prioritise gaps in patient engagement practices and processes, while also seeking to create future patient engagement tools.Read More
Dr Stuart Faulkner and Dr Teresa Finlay, University of Oxford
The aim of the PARADIGM project is to enable structured, effective, meaningful, ethical, innovative, and sustainable patient engagement (PE) that demonstrates the ‘return on the engagement’ for all stakeholders. PARADIGM’s partners are convinced of the importance of PE and are committed to working to improve its impact, value and sustainability across medicines research and development (R&D). At this midway point, it is worth reflecting on other views pertaining to PE in order to keep sight of why we are committed to this project and how we can maintain an inclusive approach as the tools we are developing begin to take shape.Read More
Mathieu Boudes – (EPF) PARADIGM Coordinator
One year. This is the time that remains for PARADIGM to have a tangible impact on the patient engagement in medicines R&D ecosystem. All the workstreams, as well as all our partners, are fully involved as we seek to deliver what will make a difference. The phase of aiming to understand and prioritize the gaps in patient engagement practices and the process will end soon, allowing the new phase to begin, that of developing the necessary tools to systematise patient engagement. Meanwhile, all the other elements of this significant project are converging to deliver the Monitoring and Evaluation Framework on time and by the end of the year.Read More
The Patient Engagement Open Forum is a unique event that aims to bring together a range of stakeholders interested in and committed to making meaningful patient engagement a reality.
In order to make this happen, stakeholders must have the right tools. The first session of the Open Forum is entitled “Learning from Good Patient Engagement Practices and Applying to your Everyday Work.”Read More
Is measuring the impact of patient engagement activities in medicines R&D, a way to sustain the cultural change for more systematic and meaningful patient engagement? We asked this question during a session at the DIA Global Annual Meeting 2019 in San Diego earlier this summer
Author: Mathieu Boudes, European Patients’ Forum and PARADIGM CoordinatorRead More
PARADIGM is proud to announce a partnership with Global CardioVascular Clinical Trialists (CVCT), a community of cardiovascular clinical trialists. They will join the PARADIGM International Liaison Group (PILG), an information hub acting as an operational platform to connect PARADIGM with key IMI and other international engagement initiatives in co-development and promote the implementation of patient engagement practices.Read More
A key PARADIGM objective was to gather and analyse perspectives from all stakeholders involved in medicines development, in order to better understand their expectations when it comes to patient engagement. Read More
An interactive workshop bringing together over 30 representatives from industry, patient organisations and academia was held to test, apply and develop a monitoring and evaluation framework for patient engagement. Read More
In March 2019, a workshop was organised to validate the final draft of the “Recommendations on the required capabilities by all stakeholders to implement patient engagement” before launching the wider consultation and to perform a trial consultation. The group of 37 participants also sought to agree on concrete plans in the areas identified as gaps where the material for facilitating patients engagement is needed.Read More
This workshop was the final step of a series of structured brainstorming exercises to identify potential sustainability scenarios for patient engagement addressing the outcomes and concepts of PARADIGM and that will be adopted by all stakeholders involved in medicines R&D. Read More
By Dr Stuart Faulkner, Programme and Operations manager, Nuffield Department of Primary Health Sciences, Oxford University, UK
Patient engagement (PE) and patient and public involvement (PPI) before, during and after the research process can help develop research questions, methods and outcomes that respond better to the needs and interests of patients, carers compared to when researchers alone in isolation. Furthermore, researchers can benefit by producing research that is more relevant and impactful.
By Begonya Nafria, Fundació Sant Joan de Déu
Children and young people represent 21% of the European population, yet they represent 100% of the future of our society.
By Nathalie Moll, Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA)
At EFPIA, we work across a wide spectrum of topics from prevention and awareness, through research and development (R&D), regulatory and Health Technology Assessment (HTA) processes, managing relationships, to developing healthcare service design and outcomes measurement. Each one has a direct impact on the lives of patients, their families and carers across Europe.
By Jean Georges, Executive Director, Alzheimer Europe
Dementia affects around nine million people in Europe. Despite many efforts, no treatment exists to date which could cure, prevent or slow down its progression. Globally, and at European level, a lot of research is being conducted which is helping to better understand what causes dementia, the risk factors, its progression, how to cope and live better with the condition and to develop more effective treatments and care options.
Editorial by Paula DeCola – Global Patient Affairs/Lead Healthy Ageing Center of Excellence at Pfizer
The term value-centred healthcare is increasingly replacing the concept of patient-centred healthcare. On the surface, this doesn’t seem to be problematic, given that patients intuitively seek value, but it is dependent on the inclusion of patient perspectives. However, the components of value have yet to be standardised. Aspects such as quality and cost are part of a number of value equations, although the prioritization or weighting of these elements can be a sticking point amongst stakeholders. Read More
Editorial by Paula DeCola – Global Patient Affairs/Lead Healthy Ageing Center of Excellence at Pfizer
The basic tenet to let go of things, and to declutter one’s surroundings, is fundamental to an organising method coined KonMari. Within healthcare systems, there is the opportunity to streamline the number of available interventions, to eliminate or let go of less effective ones.Read More
English language survey results
Chi Pakarinen, Daphnee Pushparajah, Paula Decola, Magda Chlebus, and Suzanne Ii Read More
An editorial written by Mathieu Boudes, EPF, coordinator PARADIGM and Alexandra Moutet, UCB, member of the PARADIGM Steering CommitteeRead More
PARADIGM understood from the start that the success of the initiative is dependent on a number of factors, none more important than understanding the perspectives and needs of the diverse set of stakeholders associated with the patient engagement ecosystem. These perspectives are important in the design, development, dissemination and implementation of PARADIGM; essentially these underpin the entire initiative. Read More
Not unlike the Shakespearean play, Measure for Measure, justice is critically important to PARADIGM. Both the play and the initiative are focused on the sensibilities around the concept of justice. If PARADIGM is to fulfil its promise, the overall patient engagement outputs must be justified, in other words, be found to be legitimate or valid and to have value. One important output for PARADIGM is the design of a monitoring and evaluation framework for patient engagement. Read More
A gap is defined by what is around it, a bit like a donut hole. A gap analysis is somewhat straightforward, albeit complex process that helps to identify the current holes in existing frameworks, processes and practices. A core aspect of PARADIGM’s strategic plan is to build upon the existing patient engagement activities and to bridge existing gaps. Read More
An editorial by Nicola Bedlington, EPF Secretary-General and Magda Chlebus, EFPIA Executive Director, Science Policy and Regulatory Affairs
A series of articles in EyeForPharma shows not only that patient engagement (PE) is gathering momentum but that PARADIGM is on the map.
The articles, published online and collected in a mini-magazine, address key issues in PE and include quotes from several leading PARADIGM participants. Read More
A report on the EURORDIS Round Table of Companies, Barcelona October 16, by Maarten Kraaijenhagen
Twice per year, EURORDIS organizes the European Round Table of Companies, bringing together industry, patient advocates, public officials and other experts to address patient needs.Read More
By Teresa Finlay and Lidewij Vat
On Nov 15 and 16, we attended the conference ‘International Perspectives on Evaluation of Patient & Public Involvement in Research’ in Newcastle. The conference attracted researchers, professionals and patient contributors who together discussed whether and how the impact of patient and public involvement* should be evaluated. Four themes struck us from the debate on evaluation. Read More
Dr Stuart Faulkner, Oxford University, reports on the first joint workshop of PARADIGM Work Packages 1 & 2
On Oct 11th 2018, at UCB headquarters in Anderlecht, Brussels, PARADIGM WP1 and WP2 held their first joint workshop, ‘Translating Inputs into outputs’. This marked a pivotal point in the development timelines of both work packages that facilitated detailed sharing of progress, alignment of key joint timelines and process, and discussion of how we can continue to develop together, for the greater good of the consortium. Read More
For start-up biotech companies, the potential benefits of engaging patients early and often are clear: insights on unmet patient need, guidance on how to value clinical improvement and reduced side effects, and a new way to give investors confidence in the future market for potential medicines. But making PE happen is far from straightforward.Read More
Authors: Schuitmaker, T.J., Vat, L.E. & Robinson, P.
“What is in it for me?” A question often asked by people involved in patient engagement practices. Evaluating whether engagement adds value for different stakeholder groups can be an effective tool to further support patient engagement. The PARADIGM project is a European public-private partnership that is developing ways to ensure that patients are meaningfully involved in medicines development. One of the aims of the project is to develop metrics to measure the “return on engagement”.Read More
On September 6th 2018, four European patient organisations (European Patients’ Forum (EPF), European AIDS Treatment Group (EATG), EURORDIS-Rare Diseases Europe and Alzheimer Europe and a research foundation (Fondation Sant Joan de Déu) organised a webinar on patient engagement on medicines research and development. The webinar was attended by more than 100 interested people, many of them patient representatives.
PARADIGM is receiving funding from the Innovative Medicines Initiative Joint Undertaking 2. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.