HORIZON EUROPE
Europeo
Specific Challenge:For full details of this topic, please see the topic text and webinars on the IMI website.
Alongside chemotherapy and surgery, radiotherapy (RT) has evolved to become one of the essential therapies for the treatment of cancer. However, radiotherapy is not suitable for all cancer types, and when used, the potential for negative side effects to surrounding organs can limit the dose administered leading to longer treatment times and reduced effectiveness. By delivering a high radiation dose, more precisely focused on the tumour site, proton therapy (PT) has the potential to reduce these adverse events and provide better outcomes for cancer patients.
Although the number of patients treated annually with PT is increasing, the clinical evidence supporting its effectiveness remains limited due to the lack of large multi-centre studies. There is a critical need for high quality evidence from multi-centre trials to determine the potential role of PT for various cancer indications and to allow a consensus to be reached across Europe on the most suitable indications.
A robust evidence base on the effectiveness of PT has the potential...
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Specific Challenge:For full details of this topic, please see the topic text and webinars on the IMI website.
Alongside chemotherapy and surgery, radiotherapy (RT) has evolved to become one of the essential therapies for the treatment of cancer. However, radiotherapy is not suitable for all cancer types, and when used, the potential for negative side effects to surrounding organs can limit the dose administered leading to longer treatment times and reduced effectiveness. By delivering a high radiation dose, more precisely focused on the tumour site, proton therapy (PT) has the potential to reduce these adverse events and provide better outcomes for cancer patients.
Although the number of patients treated annually with PT is increasing, the clinical evidence supporting its effectiveness remains limited due to the lack of large multi-centre studies. There is a critical need for high quality evidence from multi-centre trials to determine the potential role of PT for various cancer indications and to allow a consensus to be reached across Europe on the most suitable indications.
A robust evidence base on the effectiveness of PT has the potential to open a new treatment modality for cancers with currently very low survival rates, for example oesophageal cancer. Oesophageal cancer is the seventh most common cancer worldwide, with more than 570 000 new cases per year leading to more than 500 000 cancer deaths annually. Until recently, surgery was the main treatment for patients with localised disease. In 2012, the results of the Chemoradiotherapy for Oesophageal Cancer Followed by Surgery Study (CROSS) randomised trial demonstrated that adding neoadjuvant chemo-radiation to surgery results in a beneficial effect on pathological complete response (pCR) and survival compared to surgery alone. However, with a pCR of 30 % and a five-year overall survival rate of 45-50 %, there is still a large unmet need.
The unique properties of PT allow oesophageal cancer patients the opportunity to receive more conformal radiotherapy with the possibility of reducing the dose to the surrounding normal organs including the lungs, heart and liver. Treatment of oesophageal cancer patients with PT is under evaluation by several institutions. Recent publications present the role and the potential benefits PT offers to those patients and could lead to better patient outcomes. Nevertheless, none of those publications provide level 1 evidence.
To build a robust evidence base to assess the potential of PT in oesophageal and other cancers, multi-centre international trials have to take place. The current diversity of reimbursement and coverage policies across the EU makes these trials difficult. A public-private collaboration of proton therapy oncologists, treatment centres, software developers and equipment manufacturers is needed to define a methodology to conduct clinical trials in PT at a European scale. In addition, a key factor is the generation of robust clinical evidence which is neutral and unbiased. A clinical trial conducted in a European framework, in a collaboration between industry and public partners, has an inherent degree of independence and neutrality required by the highest standards of clinical research.
Scope:For full details of this topic, please see the topic text and webinars on the IMI website.
The main objective of this topic is to examine the value of proton therapy as a treatment modality through a clinical study in oesophageal cancer. The study will compare outcomes between pencil-beam scanning proton therapy and intensity-modulated radiation therapy (IMRT). The study will determine if proton therapy in a trimodality (radiotherapy-chemotherapy-surgery) treatment;
(i) reduces treatment-related cardio-pulmonary toxicity;
(ii) increases loco-regional tumour control and pathological complete response and the influence of dose escalation;
(iii) improves disease-free and overall survival.
Oesophageal cancer is chosen due to its relatively high occurrence in the population and the possibility to extend findings to other cancer types.
A second objective is to use the evidence generated during the oesophageal cancer study to reach a consensus on which methodology is most suitable to evaluate PT treatment for other indications. To facilitate this objective, cost-effectiveness data should be collected during the duration of the action. This objective should be supported by engaging with selected stakeholders as advisors such as the broader oncology community including oncologists (e.g. through relevant European networks), healthcare providers, health technology assessment (HTA) agencies, payers, and patient associations. In addition, the findings of the proposed project should be disseminated via publications, presentations at relevant conferences, and other suitable dissemination methods.
Expected Impact:For full details of this topic, please see the topic text and webinars on the IMI website.
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 outcome of this research is potentially practice-changing as it may define a new and improved standard for the treatment of oesophageal cancer patients and potentially patients with other cancer indications.The morbidity data from the study will allow better understanding of the dose-volume relationships for normal tissue complications, enabling refined selection of patients for proton therapy in the future.The results should allow health authorities and healthcare providers to improve the quality of care through better evidence of benefits and patient outcomes and support reimbursement decisions. In their proposals, applicants should outline how the project plans to leverage the public-private partnership model to maximise impacts on innovation, research & development; regulatory, clinical and healthcare practices, as relevant. This could include a strategy for the engagement with patients, healthcare professional associations, healthcare providers, regulators, HTA agencies, payers, etc., where relevant. An advisory group including these stakeholders should be set up.
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.
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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
Please read carefully all provisions below before the preparation of your application.
The IMI2 JU 20th 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 submission, evaluation 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 o...
Please read carefully all provisions below before the preparation of your application.
The IMI2 JU 20th 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 submission, evaluation 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
IMI2 JU Annual Work Plan 2020
IMI2 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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