HORIZON EUROPE
Europeo
Specific Challenge:There is a growing body of evidence showing that patient-stakeholder engagement at key decision points throughout the medicines life cycle (from discovery to outcomes monitoring) can drive better innovation and process efficiency and quality. Processes and outcomes become more relevant to individual patients, patient groups, healthcare consumers in general and society at large when they are based on a mutual understanding between patients, other healthcare stakeholders and manufacturers about their respective needs.
Many initiatives have been started that focus on bringing the patient closer to the centre of medicines development, authorization and reimbursement processes in the EU. Progress, however, remains too slow, mainly because of lack of harmonisation:
There is no clear alignment among stakeholders on the nature and value of patient engagement at different points of the medicines lifecycle. This results in inconsistent engagement, often leading to the absence of under-representation of patient insights. There is a lack of broadly accepted tools, processes, guidance and capabilities amongst stakeholders, resulting in the use of...
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Specific Challenge:There is a growing body of evidence showing that patient-stakeholder engagement at key decision points throughout the medicines life cycle (from discovery to outcomes monitoring) can drive better innovation and process efficiency and quality. Processes and outcomes become more relevant to individual patients, patient groups, healthcare consumers in general and society at large when they are based on a mutual understanding between patients, other healthcare stakeholders and manufacturers about their respective needs.
Many initiatives have been started that focus on bringing the patient closer to the centre of medicines development, authorization and reimbursement processes in the EU. Progress, however, remains too slow, mainly because of lack of harmonisation:
There is no clear alignment among stakeholders on the nature and value of patient engagement at different points of the medicines lifecycle. This results in inconsistent engagement, often leading to the absence of under-representation of patient insights. There is a lack of broadly accepted tools, processes, guidance and capabilities amongst stakeholders, resulting in the use of anecdotal and/or fragmented information. Many patient groups lack internal resources (people, time, mobility, legal) and the general capability to engage with multiple and different types of stakeholders. Perceived or real differences amongst organisations’ conflicts of interest rules block progress. Therefore, there is the need to establish transparent and integrated standards that permit patient involvement during the medicines lifecycle (including associated products and services). The resolution of 4 specific issue groups is required to make progress: recognition of the validity and value of such engagement; metrics to demonstrate value; capability development; and rules of engagement.
Scope:In the context of this project, the scope of the term “patient” includes those people who have the medical issues or symptoms as well as those caring for or living with them.
This project represents an opportunity to enable patients to better provide their perspectives - in qualitative and quantitative terms - in the medicines pathways from discovery to outcomes monitoring and beyond. The input from those who are currently under-represented, or may not normally participate in critical decision-making is of particular interest, including patients not affiliated to patient groups, vulnerable populations such as minors or the elderly. In addition, it will provide a framework and guidance for all EU stakeholders about who and how to engage, when and what information is required, to ensure adequate input from patients and healthcare consumers.
The project will specifically aim at addressing several challenges that currently hinder productive patient-stakeholder engagement:
Adoption of practices by stakeholder groups by creating minimum expectations for effective engagement: There are good examples of patient engagement practice. However, the landscape is still fragmented and this project offers the opportunity to make the practices more consistent across the research sector. It will also help to align efforts to measure the impact of specific types of practices on process efficiency, quality as well as the effectiveness of processes, results and decision-making based on the practices. A blueprint representing the minimum expectations on how to engage effectively, when, and with whom) along with metrics are needed to support implementation within industry (including companies operating globally) and healthcare authorities, as well as other decision makers. This will assist to determining the resources and capabilities necessary for implementing patient engagement across the medicines lifecycle. A blueprint which includes metrics will also help patients/advocates to determine where to focus time and resources in order to gain maximum benefit. Engagement capability: All stakeholders need to have defined knowledge, capabilities and be able to sustain their involvement in order to effectively and routinely be part of the engagement processes. Rules of engagement: Co-creation involving all the key players is required to ensure that each stakeholder’s perspective is considered and to achieve an ethical engagement. There are practical considerations that need to be taken into account when research and health system decision makers, patients and health advocates are engaged; these need to be more clearly defined. The project will not address policy development advocacy nor will it duplicate any deliverables specifically addressed under other IMI and relevant non-IMI-initiatives.
Beyond filling obvious gaps in the engagement toolkit/practice, the project will build on existing tools and learn from good and bad experience and advance their utility.
The project’s aim is not intended to set a rigid framework or oversystematise patient-stakeholder engagement but instead to provide a blueprint and tools that will enhance engagement and making it a seamless part of the R&D and decision making processes.
Expected Impact:The project is expected to advance patient engagement and medicines life cycle and make it more meaningful, systematic and effective. It will facilitate and further enhance patient perspectives in the process. This will be accomplished through creating more clarity on the process and provide patient and their partners in research with the tools that facilitate smooth and useful interaction. Enhanced and systematic engagement of patients and healthcare consumers in medicines lifecycle will ultimately contribute to:
improved and sustainable innovation and meaningful outcomes for all stakeholders; successfully addressing objectives of IMI to reduce attrition, speed up patient access and improve patient outcomes and experiences. The applicants will propose a course of action with the maximum impact for the patients’ communities and for the quality of interactions in the medicines lifecycle.
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Características del consorcio
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La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
You can access the description of the different topics in the Call 10 topics text.
The budget breakdown for this Call is given at the end of the Call topics text, in the Conditions for this Call for proposals section, as well as the following information :
List of countries and applicable rules for funding
Eligibility and admissibility conditions
Evaluation criteria and procedure, scoring and treshold: described in the IMI2 Manual for evaluation, submission and grant award.
Indicative timetable for evaluation and grant agreement
Provisions, proposal templates and evaluation forms for the type of actions under the Call topics:
IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):
Summary of the most relevant provisions for participating in IMI2 actions
Proposal templates are available after entering the submission tool
Standard evaluation form
IMI2 Model Grant Agreement
Template for essential clinical trials information
Please read carefully all provisions below before the preparation of your application.
You can access the description of the different topics in the Call 10 topics text.
The budget breakdown for this Call is given at the end of the Call topics text, in the Conditions for this Call for proposals section, as well as the following information :
List of countries and applicable rules for funding
Eligibility and admissibility conditions
Evaluation criteria and procedure, scoring and treshold: described in the IMI2 Manual for evaluation, submission and grant award.
Indicative timetable for evaluation and grant agreement
Provisions, proposal templates and evaluation forms for the type of actions under the Call topics:
IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):
Summary of the most relevant provisions for participating in IMI2 actions
Proposal templates are available after entering the submission tool
Standard evaluation form
IMI2 Model Grant Agreement
Template for essential clinical trials information
Información adicional de la convocatoria
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