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
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
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
Dr Rosamund Yu, Head of PPI and Research Communications at the NIHR biomedical research centre at University College London Hospital, outlines how cancer patients were instrumental in the successful development of a digital health toolkitRead 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
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
The importance of collaboration and alignment and why it takes a village to achieve meaningful patient engagement (PE) was the opening call to action at the recent Patient Engagement Open Forum – Delivering patient engagement beyond aspirations. Over 250 delegates participated in the two-day immersive event which took place in Brussels, Belgium on 18–19 September 2019. 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
The progress of the PREFER project will lead to broader use of patient preference studies in medicines R&D, write EPF’s Camilla Habre (Project Officer) and Mathieu Boudes (PARADIGM Coordinator) in a short report from the PREFER Annual Meeting 2019 Read More
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
Developing appropriate policies for compensating patients, patient organizations, and family members for patient-engagement activities have been a hot topic for those involved in patient engagement in recent years.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
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
Ingrid Klingmann outlines the objectives and work of the PARADIGM Ethics Expert Panel
Patient engagement, by definition, is the meaningful and active collaboration of patients, patient advocates, patient representatives and/or carers in the decisions and judgements within the medicine lifecycle with all other relevant stakeholders involved. PARADIGM, an IMI project, aims at developing a framework of consensus-based recommendations on ethically-sound patient engagement practices, processes and tools, as well as on methods to measure and demonstrate the added value of innovative and effective approaches to patient engagement.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 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.
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
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
Author: Teresa Finlay, Postdoctoral Researcher, IRIHS Research Group
DIA Europe, a member of the PARADIGM International Liaison Group, held its annual conference in Vienna in early February. I quickly forgot the sun glinting on the Danube and biting cold when the impressive programme commenced. Structured around seven tracks concerning medicines research and development, the overarching theme that prevailed at conference sessions was change, its realities, its impact and management. I was fortunate to be able to attend the conference courtesy of one of PARADIGM’s industry partners, MSD, and with the IMI-PARADIGM project in mind, I focused on sessions related to patient engagement.
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
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 ultimate goal of patient engagement throughout the lifecycle of medicines is to develop safer, more effective therapeutic solutions for patients that closely match their specific needs, and to deliver them faster and more efficiently. The overarching mission of PARADIGM is to participate in the creation of a sustainable framework that allows structured, meaningful, and ethical patient engagement during three of the key decision-making points in the medicines development process; the research priority setting, the design of clinical trials, and early dialogues with regulators and HTA bodies.Read 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
The World Orphan Drug Congress took place in Barcelona, Spain, late last year. Several PARADIGM project partners attended the Congress, where they presented the project to the rare diseases community. Given the project’s emphasis on building patient engagement, particularly within vulnerable populations, PARADIGM’s presence was of paramount importance. On Rare Disease Day 2019, February 28, the PARADIGM members who attended the conference reflect on the role patient engagement has to play in this tight-knit but pro-active community.
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
One of the essential outputs from PARADIGM will be a set of recommended core capabilities that should underpin patient engagement in the defined priority areas within the medicines lifecycle. These capabilities are composites of individual attributes; this includes knowledge, skills and attitudinal aspects of patient engagement that are context-bound. Additionally, organisational capabilities need to be considered such as processes, tools and systems. 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
If a tree falls in the forest and no one hears it, does it make a sound? This philosophical question provides an important cautionary tale for the PARADIGM project. If PARADIGM delivers on the promised outputs, but no one knows about it, in essence, it fails. A critical part of success is awareness and transparency during the project, as well as uptake of the outputs upon its completion. Our remit involves not only the creation of content; it is about ensuring the target audience understands that content and its contextual underpinning.Read More
Sustainability is the new catchall phrase, yet when it comes to initiatives like PARADIGM, we cannot afford to offer empty promises. Sustainability is an essential element of success. If patient engagement is to truly deliver, it must become systematic, especially as the positive outcomes of patient engagement will be experienced over long periods of time, across a very broad scope of R&D programmes. 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.
JOINT STATEMENT on the signing of a Memorandum of Understanding
Brussels, September 13th, 2018
The two Innovative Medicines Initiative (IMI) consortia PARADIGM, Patients Active in Research and Dialogues for an Improved Generation of Medicine (co-led by the European Patients’ Forum and the European Federation of Pharmaceutical Industries and Associations) and PREFER, Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (co-led by Uppsala University and Novartis) have established a Memorandum of Understanding aiming to enhance the cooperation and collaboration between the two projects.
Chris Roberts lives in north Wales and was diagnosed with early onset mixed dementia (vascular and Alzheimer’s) in 2012, in his early fifties. Since the diagnosis, Chris and his wife Jayne have been actively involved in raising awareness of dementia and have inspired many other people to continue to live life to the full with dementia. Chris is an ambassador for research in the UK, Vice Chair of the European Working Group of People with Dementia (EWGPWD) and is a co-founder and member of the 3 Nations Dementia Working Group.
We talked to Chris and Jayne about their participation, together with the other members of the EWGPWD, in a consultation about the PARADIGM project on 27-28 June in Brussels.
The DIA (Drug Information Association) 2018 Global Annual Meeting took place recently in Boston. This unique event gathered together over 6,000 professionals in the pharmaceutical, biotechnology, and medical device communities from more than 50 countries.
DIA has provided a global yet neutral stage for collaboration to address healthcare challenges for more than 50 years. The Global Annual Meeting gathered stakeholders from across the world to openly knowledge share, generating insights beyond boundaries to advance innovation in healthcare product development and lifecycle management globally.
Just like Rome, PARADIGM wasn’t built in a day. Rather it was borne out of a desire to systematise the many patient engagement efforts that had begun to proliferate in this new era of patient-centredness within medicine R&D and healthcare delivery.
The PARADIGM consortium and its mission is the most recent manifestation of the work being done in the patient engagement arena. All partners have a proven track record in the area, and have been willing to bring their individual knowledge and expertise to the project.
Brussels, 10 April 2018 – A brand new collaboration between 34 public and private partners was launched today, with the aim to make meaningful patient engagement in the life cycle of medicines a reality. PARADIGM stands for Patients Active in Research and Dialogues for an Improved Generation of Medicines and is funded by the Innovative Medicines Initiative.