HORIZON EUROPE
Europeo
Specific Challenge:Publications have previously shown that only 30% of marketed drugs in Europe and worldwide include a paediatric authorisation and less than 50% of authorised medicines commonly used in children had been properly tested in this population. This rate drops 10% in the vulnerable patient population in neonatal intensive care units. Even if the situation may improve with the different paediatric legislation in place, there is still a major societal challenge to be addressed.
There are many scientific and operational challenges faced by both pharma companies and academia when running paediatric clinical trials. Given the paucity of patients available for study in many paediatric indications and the need for multiple capable sites to satisfy enrolment in trials, the clinical trial infrastructure across the EU is not sufficiently organised, and lacks adequate funds and scale to consistently and efficiently deliver both industry-sponsored and academic non-industry sponsored clinical trials leading to new drug approval, complete labelling of existing drugs, valid comparisons between existing marketed therapies, or observational studies informing the natural hi...
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Specific Challenge:Publications have previously shown that only 30% of marketed drugs in Europe and worldwide include a paediatric authorisation and less than 50% of authorised medicines commonly used in children had been properly tested in this population. This rate drops 10% in the vulnerable patient population in neonatal intensive care units. Even if the situation may improve with the different paediatric legislation in place, there is still a major societal challenge to be addressed.
There are many scientific and operational challenges faced by both pharma companies and academia when running paediatric clinical trials. Given the paucity of patients available for study in many paediatric indications and the need for multiple capable sites to satisfy enrolment in trials, the clinical trial infrastructure across the EU is not sufficiently organised, and lacks adequate funds and scale to consistently and efficiently deliver both industry-sponsored and academic non-industry sponsored clinical trials leading to new drug approval, complete labelling of existing drugs, valid comparisons between existing marketed therapies, or observational studies informing the natural history of disease indications.
A broad multidisciplinary public-private consortium is required to meet the challenges and be transformative for collectively addressing children’s needs for better medicines.
Scope:The overall vision of this topic is to create a large collaborative paediatric network that facilitates the development and availability of new drugs and other therapies, and the expansion of knowledge about drugs currently in practice for the entire paediatric population.
To achieve this vision the objectives are to:
Create the network with a lean central coordinating organisation, arranged around “national hub coordinating centres” cooperating with multiple sites within each member state Set up scientific advice and trial readiness groups Test the viability of the network by conducting clinical studies Develop and implement a sustainable business model for the network Prepare the network to European Network for Paediatric Research at the European Medicines Agency (Enpr-EMA) membership
Expected Impact:This project will have an impact on a number of areas including
Better access for paediatric patients to new experimental therapies Increased efficiency of executing trials (reduced timelines & cost) Enhanced role of clinicians and patient/parent advocacy groups in planning and designing studies Opportunity for European clinical research personnel, clinical research sites, and clinical research organisations to collaborate across national borders making Europe a more competitive place for the conduct of paediatric clinical trials
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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
You can access the description of the different topics in the Call 10 topics text.
The budget breakdown for this Call is given at the end of the Call topics text, in the Conditions for this Call for proposals section, as well as the following information :
List of countries and applicable rules for funding
Eligibility and admissibility conditions
Evaluation criteria and procedure, scoring and treshold: described in the IMI2 Manual for evaluation, submission and grant award.
Indicative timetable for evaluation and grant agreement
Provisions, proposal templates and evaluation forms for the type of actions under the Call topics:
IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):
Summary of the most relevant provisions for participating in IMI2 actions
Proposal templates are available after entering the submission tool
Standard evaluation form
IMI2 Model Grant Agreement
Template for essential clinical trials information
Please read carefully all provisions below before the preparation of your application.
You can access the description of the different topics in the Call 10 topics text.
The budget breakdown for this Call is given at the end of the Call topics text, in the Conditions for this Call for proposals section, as well as the following information :
List of countries and applicable rules for funding
Eligibility and admissibility conditions
Evaluation criteria and procedure, scoring and treshold: described in the IMI2 Manual for evaluation, submission and grant award.
Indicative timetable for evaluation and grant agreement
Provisions, proposal templates and evaluation forms for the type of actions under the Call topics:
IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):
Summary of the most relevant provisions for participating in IMI2 actions
Proposal templates are available after entering the submission tool
Standard evaluation form
IMI2 Model Grant Agreement
Template for essential clinical trials information
Información adicional de la convocatoria
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