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
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
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
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 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
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
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
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.