HORIZON EUROPE
Europeo
Specific Challenge:Non-communicable diseases represent a significant burden on individuals and healthcare systems, accounting for 86 % of all deaths in Europe. Innovative and effective healthcare interventions are required to find a cure or provide best quality of care when prevention strategies have failed. While considerable knowledge has been generated by biomedical research, potentially promising healthcare interventions often fail clinical validations and as a consequence do not reach patients.
Scope:
Proposals should conduct early stage[1] clinical trial(s) to validate novel or refined healthcare interventions[2] for patients suffering from non-communicable diseases (Rare diseases and regenerative medicine are not within the scope of this topic). Clinical trial(s) should be supported by proof-of-concept[3] of clinical safety and efficacy[4] and may be investigator-initiated. Both preclinical research and the draft clinical trial protocol should be completed at the time of submission of the proposal. Applicants should present a sound feasibility assessment, including an appropriate patient selection and realistic recruitment plans, justified...
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Specific Challenge:Non-communicable diseases represent a significant burden on individuals and healthcare systems, accounting for 86 % of all deaths in Europe. Innovative and effective healthcare interventions are required to find a cure or provide best quality of care when prevention strategies have failed. While considerable knowledge has been generated by biomedical research, potentially promising healthcare interventions often fail clinical validations and as a consequence do not reach patients.
Scope:
Proposals should conduct early stage[1] clinical trial(s) to validate novel or refined healthcare interventions[2] for patients suffering from non-communicable diseases (Rare diseases and regenerative medicine are not within the scope of this topic). Clinical trial(s) should be supported by proof-of-concept[3] of clinical safety and efficacy[4] and may be investigator-initiated. Both preclinical research and the draft clinical trial protocol should be completed at the time of submission of the proposal. Applicants should present a sound feasibility assessment, including an appropriate patient selection and realistic recruitment plans, justified by publications or preliminary results. Proposals should demonstrate potential clinical benefit, including consideration of patient-reported outcomes when relevant. Sex and gender differences should be considered; age and other stratification criteria[5] should be considered when relevant. Where appropriate, patients and carers should be involved and their views reflected in research activities. Proposals should demonstrate evidence of preliminary consultations with ethics and regulatory authorities at the time of submission.
The Commission considers that proposals requesting a contribution from the EU of between EUR 4 and 6 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.
Expected Impact:Candidate healthcare interventions that would generate meaningful advances in clinical practice and care for patients with non-communicable diseases for late stage clinical trials.Potential to improve patient-centred outcomes and to impact on the disease burden of individual patients and health care systems following validation in late stage clinical trials.
Cross-cutting Priorities:Open InnovationSocio-economic science and humanitiesGender
[1]For pharmacological interventions: phase 1 and phase 2 clinical trials
[2]Applicants may address any mono- or combinatorial pharmacological and/or non-pharmacological intervention.
[3]Comparative effectiveness studies are not within the scope of this topic.
[4]Clinical Trial Regulation EU No. 536/2014: https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
[5]Such as, clinical and molecular features of the patient and/or the disease, socio-economic status, etc.
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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
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects. See the information in the Online Manual.
Also, in recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding to support its participation in projects supported under this topic.
2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
3. Evaluation:
Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
Submission and evaluation processes are described in the Online Manual.
The thresholds for each criterion for the second stage of the two-stage calls for these topics will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (two-stage call):
For stage 1: maximum 3 months from the deadline for submission.
For stage 2: maximum 5 months... 1. Eligible countries: described in Annex A of the Work Programme.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects. See the information in the Online Manual.
Also, in recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding to support its participation in projects supported under this topic.
2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
3. Evaluation:
Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
Submission and evaluation processes are described in the Online Manual.
The thresholds for each criterion for the second stage of the two-stage calls for these topics will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (two-stage call):
For stage 1: maximum 3 months from the deadline for submission.
For stage 2: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
General MGA - Multi-Beneficiary
Annotated Grant Agreement
Essential information for clinical trials
6. Additional provisions:
Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.
Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.
8. Additional documents:
Introduction WP 2018-20
Health, demographic change and well-being WP 2018-20
General annexes to the Work Programme 2018-2020
Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme
7. 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 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.
Información adicional de la convocatoria
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