HORIZON EUROPE
Europeo
Specific Challenge:Patient non-adherence to prescribed treatment is an issue that affects patient health outcomes and healthcare system costs worldwide. It is estimated that it contributes to 200 000 premature deaths in the EU each year, and the annual costs of avoidable hospitalisations, emergency care and adult outpatient visits are assessed at EUR 125 billion. Addressing the issues of adherence would significantly improve both individual patient outcomes and reduce societal costs.
Many researchers have approached the topic of adherence but insights have necessarily been limited to specific sub-topics due to the breadth of the field. Unless the underlying problem is well-defined and understood, the probability of developing effective solutions with broad and consistent impact is low.
Consequently, there is a need to generate a more comprehensive theoretical and empirical understanding of the underlying causes of these patient behaviours and any interactions. This topic proposes the creation of a generalised model, grounded in behavioural theory, which integrates significant factors affecting non-adherent behaviour. This would provide a robust definition...
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Specific Challenge:Patient non-adherence to prescribed treatment is an issue that affects patient health outcomes and healthcare system costs worldwide. It is estimated that it contributes to 200 000 premature deaths in the EU each year, and the annual costs of avoidable hospitalisations, emergency care and adult outpatient visits are assessed at EUR 125 billion. Addressing the issues of adherence would significantly improve both individual patient outcomes and reduce societal costs.
Many researchers have approached the topic of adherence but insights have necessarily been limited to specific sub-topics due to the breadth of the field. Unless the underlying problem is well-defined and understood, the probability of developing effective solutions with broad and consistent impact is low.
Consequently, there is a need to generate a more comprehensive theoretical and empirical understanding of the underlying causes of these patient behaviours and any interactions. This topic proposes the creation of a generalised model, grounded in behavioural theory, which integrates significant factors affecting non-adherent behaviour. This would provide a robust definition of the problem – a foundation for understanding and predicting patient behaviour – and guidance to develop and implement cost-effective tools and solutions for patients, healthcare professionals (HCPs) and other healthcare stakeholders, which directly target the causes of non-adherence and, ultimately, improve patient outcomes and reduce health system costs.
Creating the necessary understanding for an effective model will require broad engagement and skills, particularly since we are targeting a disease agnostic model. The perspectives of patients, healthcare providers, academic experts, behavioural scientists, digital and data analytics experts, and regulatory bodies will be essential to maximise the benefits and ensure all sectors of society are well served.
Please refer to Call topic text.
Scope:The aims of the Call topic are to:
develop a comprehensive understanding of the factors which affect patient needs and adherence, independently from the therapeutic area (i.e. generic or disease-agnostic), in a real-world context (as opposed to clinical setting);identify the most significant factors; evaluate existing models and then either create an open access behavioural model or further develop an existing model;collect additional real-world data to refine the model; provide tools that will enable healthcare stakeholders to cost-effectively develop and implement solutions to address patient needs and improve adherence rates. A behavioural model will be created or selected and refined. In parallel, adherence modules will be added to existing patient studies to fill identified gaps in the data.
While disease-agnostic, the model should be able to increase the prediction power and accuracy when applying additional, disease-specific inputs.
Once developed or refined, the model will be validated for multiple ages (including paediatric), ethnicities and conditions. It is anticipated that this shall be achieved using the following therapeutic areas, dependent on access to patients provided by members of the consortium:
Cardiovascular;Oncology;Immunology;Neurology;Endocrinology andRare Disease. This list is not exhaustive. Where opportunities arise to validate in other additional therapeutic areas, these should be explored.
Please refer to Call topic text.
Expected Impact:In their proposals, applicants should describe how the outputs of the project will contribute to the following impacts and include wherever possible baselines, targets and metrics to measure impact:
Positive impact on healthcare at a societal level through enhanced adherence, targeted use of resources, and improved overall patient outcomes;Validated foundation to compile and understand factors affecting patient non-adherence to treatment regimens and the relative weighting of these factors; Identification of sub-groups of the population with similar causes of non-adherent behaviour such that solutions can be tailored to population needs and applied in a cost-effective manner to multiple treatment conditions;Model for the basis of a consistent approach to non-adherence across the industry; a framework for future development of patient-centric solutions, with the capacity for the model to evolve with the future needs of patient populations; Guidance, based on the validated model, for identifying patient needs and tailoring support tools for patients and HCPs which most closely address patient adherence needs and improve patient outcomes and quality of life;The data collected during the project will provide a broad and deep resource for future understanding of adherence. In their proposals, applicants should outline how the project plans to leverage the public-private partnership model to maximise impact on innovation, research & development, as well as regulatory, clinical and healthcare practices, where relevant. This could include a strategy for engagement with patients, healthcare professional associations, healthcare providers, regulators, Health Technology Assessment (HTA) agencies, payers etc., where relevant.
In addition, applicants should describe how the project will impact the competitiveness and growth of companies including SMEs.
In their proposals, applicants should outline how the project will:
Manage research data including use of data standards;Disseminate, exploit, and sustain the project results. This may involve engaging with suitable biological and medical sciences Research Infrastructures;Communicate the project activities to relevant target audiences. It is expected that the model, guidance and any development tools will be made available through an open source process to achieve the aims of maximising the number of patients receiving support.
Please refer to Call topic text.
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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 23rd Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call, along with the information below, are given at the end of the Call topics text, in the Call Conditions section.
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... Please read carefully all provisions below before the preparation of your application.
The IMI2 JU 23rd Call for proposals topics text as well as the Call Conditions are available here.
The budget breakdown for this Call, along with the information below, are given at the end of the Call topics text, in the Call Conditions section.
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 required only at stage 2! Therefore, in the Proposal Submission Form at stage 1, the answer options to the question "Are clinical studies/trials/investigations included in the work plan of this project?” are disabled.
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
IMI2 Annual Work Plan 2020
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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