HORIZON EUROPE
Europeo
Specific Challenge:Approximately 5,000-8,000 distinct rare diseases (RD) affect 6-8% of the EU population i.e. between 27 and 36 million people; 263-446 million people are affected globall. Despite scientific advances, in Europe, the fact remains that fewer than 10% of RD patients receive treatment and only 1% are managed using an approved treatment. Delivering effective treatments to RD patients where the prevalence is low has been described as one of the major global health challenges of the 21st century. One of the main challenges for RDs is related to diagnosis because RDs are characterised by a broad diversity of syndromic disorders and symptoms that vary from disease to disease and from patient to patient suffering from the same disease. In isolation, these symptoms can be very common, leading to misdiagnosis. Altogether, this leads to a lengthy and burdensome path to diagnosis that can take, on average, take eight years[1], often involving pointless treatments, creating a heavy human and societal burden that could be avoided by earlier diagnosis.
Please refer to Call topic text.
Scope:The overall objective of this call topic is to shorten th...
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Specific Challenge:Approximately 5,000-8,000 distinct rare diseases (RD) affect 6-8% of the EU population i.e. between 27 and 36 million people; 263-446 million people are affected globall. Despite scientific advances, in Europe, the fact remains that fewer than 10% of RD patients receive treatment and only 1% are managed using an approved treatment. Delivering effective treatments to RD patients where the prevalence is low has been described as one of the major global health challenges of the 21st century. One of the main challenges for RDs is related to diagnosis because RDs are characterised by a broad diversity of syndromic disorders and symptoms that vary from disease to disease and from patient to patient suffering from the same disease. In isolation, these symptoms can be very common, leading to misdiagnosis. Altogether, this leads to a lengthy and burdensome path to diagnosis that can take, on average, take eight years[1], often involving pointless treatments, creating a heavy human and societal burden that could be avoided by earlier diagnosis.
Please refer to Call topic text.
Scope:The overall objective of this call topic is to shorten the path to RD diagnosis by using newborn / paediatric (infants during their first weeks of life) genetic screening; and, via application of advanced digital technologies that enable rare disease diagnosis / identification. The latter might require consolidation of existing fragmented efforts.
The specific objectives are:
Assessment and development of a comprehensive, strategic overview of existing converging RD resources e.g. databases, registries (such as the EU RD platform), natural history projects, platforms, reference networks, rare disease academic centers of excellence (e.g. European Reference Networks (ERNs)), and initiatives for evaluation / identification of potential collaboration and synergies;Federation of available RD databases into a RD metadata repository amenable to machine learning or other advanced digital tools;Co-creating a sustainable strategy for newborn genetic screening and pilot it. This could start directly after achieving objective 1;Based on the output of objectives 1 & 2:a) Repurposing of pre-existing diagnosis AI algorithm to identify early onset RD patients in electronic health records (EHRs). This will include at least 3 pilots in better-known rare diseases (with the understanding that solutions and algorithms developed or adapted should be amenable or made amenable to be emulated for larger sets of better-known RDs) where more robust data is available to train and test the AI algorithm(s), and / or;b) Design and development of new AI algorithm(s) to achieve the above goal.Based on insights generated by objectives 1, 2 & 4, either repurposing or development of a broad AI RD diagnosis “symptom checker” to help undiagnosed RD patients going from one health care provider (HCP) to another. In addition, exploration of further viable options to implement the symptom checker in actionable solutions for HCPs and patients. 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, baseline, targets and metrics to measure impact.
The Rare Disease conundrum:
Despite the recent rise in RD research and development, most RDs remain under-studied, and therefore under-treated / cared for. This can be attributed for the most part to:
Patients are not identified / diagnosed;Lack of epidemiological data;No natural history of disease data;No validated endpoint / patient-reported-outcomes (PROs);Patient are rare, experts are even rarer. This has the pernicious additional effect of blunting interest in diagnosis / screening initiatives, as it would lead to patients being diagnosed with no concrete medical or clinical option. This poses an ethical challenge, which unfortunately feeds the conundrum. This has been identified as a major problem for the rare disease community.
This Call topic anticipates the following benefits:
For patients:Decreased time to the right diagnosis;Improved patient journey;Better healthcare;Increased quality of life;Decreased irreversible organ damage;Access to their own healthcare data.For healthcare:Implementation of digital transformation in healthcare;Paradigm change in rare disease diagnosis;Improved diagnostic tools;Improved understanding of disease;Higher accuracy in clinical decisions;Better care delivery;Integrated care among different specialties.For research:Advances in utilisation of digital technologies;Increased disease knowledge for future research;Improved data availability for future research.For society:Decreased burden for family and carers;Increased trust in the healthcare system;Better use of data for public health;Improved value-based healthcare. In their proposals, applicants should outline how the project plans to leverage the public-private partnership model to maximise impact on innovation, research & development; regulatory, clinical and healthcare practices, as 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 and, to the extend relevant, the data standards developed by the European Joint Programme on Rare diseases (EJP RD) and the EU RD platform193 for research and registries data respectively, as well as the use of EUPID;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. Please refer to Call topic text.
[1]http://download2.eurordis.org.s3.amazonaws.com/documents/pdf/Undiagnosed-International-Joint-Recommendations.pdf
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Características del consorcio
:
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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