HORIZON EUROPE
Europeo
Specific Challenge:1. Patient outcomes and their experience of healthcare, and thus their overall care, could be improved through systematic capture of the patient voice and perspective.
It is important to complement existing clinical outcome measurements with patient-generated measures of disease and health-related quality of life (HRQOL) to ensure that the patient perspective of disease and the impact of healthcare interventions are more completely captured and that disease heterogeneity is better understood.
In order to achieve this, it is essential to provide patients with tools that have the ability to better capture the entirety of the impact of a disease and treatments (e.g. signs, symptoms, tolerability), allowing them to document their disease more completely and in a structured manner. To be effective, these tools should be built on the basis of accepted standards, developed in partnership with all relevant stakeholders and accepted and integrated into the existing healthcare ecosystem.
2. A reward system that truly focuses on value requires measurement and transparency of patient outcomes.
At the level of the individu...
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Specific Challenge:1. Patient outcomes and their experience of healthcare, and thus their overall care, could be improved through systematic capture of the patient voice and perspective.
It is important to complement existing clinical outcome measurements with patient-generated measures of disease and health-related quality of life (HRQOL) to ensure that the patient perspective of disease and the impact of healthcare interventions are more completely captured and that disease heterogeneity is better understood.
In order to achieve this, it is essential to provide patients with tools that have the ability to better capture the entirety of the impact of a disease and treatments (e.g. signs, symptoms, tolerability), allowing them to document their disease more completely and in a structured manner. To be effective, these tools should be built on the basis of accepted standards, developed in partnership with all relevant stakeholders and accepted and integrated into the existing healthcare ecosystem.
2. A reward system that truly focuses on value requires measurement and transparency of patient outcomes.
At the level of the individual patient, the data generated, once structured and subjected to a degree of standardisation, will enable patients to have more productive interactions with their healthcare provider. At the level of the healthcare system, this data will allow a systematic measurement of health outcomes and the possibility to set up a reward system based on value – which can be defined as the level of health outcomes achieved for a given cost.
3. There is a lack of models for capturing and managing patient-reported health data in an ethical and sustainable way.
Structured health data is invaluable for all stakeholders, from the individual patient, healthcare professionals (HCPs), the life science industry, and policy makers to the patient advocacy groups. There have been a few successful examples of approaches to integrate patient-reported health data into clinical care. In an era of greater focus on the patient, it is thus critical for a society that patient-reported health and experience data is captured and managed in an ethical manner ensuring broad and appropriate access while safeguarding patients’ privacy and building high levels of trust.
Scope:The main goals are:
1. Identify appropriate standards for capturing the patient perspective when measuring health outcomes and patients’ experience of healthcare, and obtain support for these standards among relevant stakeholders.
2. Implement appropriate technology solutions (including adopting existing technology where appropriate) that would allow individual patients to record and measure their outcomes according to these standards and use the information for a more structured dialogue with their HCPs.
3. Establish the appropriate platform to collect, process and manage data in the best interest of patients, patient organisations, health authorities, healthcare professionals, the research community and health care payers.
4. Create a sustainable, socially acceptable and ethical model for the continuous collection of data and an appropriate model for providing access to the identifiable or anonymised or aggregated data to researchers with a legitimate interest in analysing them.
These goals can be achieved through the creation of health outcomes observatories in three selected disease areas: diabetes type 1 and 2, inflammatory bowel disease and cancer (side effects of chemotherapy and immune-oncology). The observatories will collect health data in at least three different European countries for each disease area.
Expected Impact:1. Enable individual patients to:
receive close to real-time information on their disease status;hold more informed discussions with healthcare professionals about their health status and options;better understand how their status compares with other patients with a similar condition;share their data and help the broader patient community. 2. Allow healthcare professionals to:
track the evolution of their patients;enable a different outcome-based conversation;better inform and enhance clinical decisions based on the patient perspective. 3. Allow patient organisations to:
assess the status and dynamics of their patient population;increase engagement with other healthcare stakeholders in evidence-based advocacy;further contribute to improving the healthcare system. 4. Allow health authorities and healthcare providers to:
improve the quality of care through better and more transparent evidence of patient measures and outcomes; drive research agendas and investments in the right areas;ensure the sustainability of healthcare systems in finding ways to improve the allocation of resources. 5. Allow pharmaceutical companies and other innovative companies to use data to:
enable ethical utilisation of the observatory data as legally appropriate;generate insights that can be used to support the design and direction of the development of new treatments;generate robust evidence that can be used in submissions to regulators, health technology assessment (HTA) agencies and other decision makers.
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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
The IMI2 JU 18th Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information :
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.
Signat... Please read carefully all provisions below before the preparation of your application.
The IMI2 JU 18th Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information :
1. Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.
2. Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.
Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.
3. Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.
4. Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.
Signature of grant agreements: maximum 3 months from the date of informing successful applicants.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):
Standard evaluation form
Proposal templates are available after entering the submission tool
Proposal template stage 1
Proposal template stage 2
IMI2 Model Grant Agreement
Clinical trial template – the Clinical Trial template is compulsory at stage 2 only !
6. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the H2020 main Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.
7. Additional documents:
Summary of the most relevant provisions for participating in IMI2 actions
1st Amended IMI2 Amended Annual Work Plan 2019
IMI2 Regulators Guidance tool for researchers
IMI JU derogation to H2020 Rules for Participation
Horizon 2020 Rules for Participation
Horizon 2020 Regulation of Establishment
Horizon 2020 Specific Programme
Información adicional de la convocatoria
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