Specific challenge: Knowledge about the overall benefit of healthcare interventions in the paediatric population is currently limited and may result in inappropriate interventions with acute or potentially lifelong impact on health and well-being.
Increasing knowledge in the areas of intervention effectiveness and clinical research has the potential to achieve system-wide improvements in health care quality and health outcomes. Effectiveness research in children and adolescents is required which is targeted, designed, conducted, and reported in ways that include clinically important differences in the type and course of disease in children.
Scope: Proposals should focus on clinical research approaches providing a deeper understanding of effectiveness, efficacy and safety of healthcare interventions and the use of health technology assessment methods in the paediatric population.
In order to achieve this, applicants should propose a detailed programme based on clinical trials and/or real world data. The programme should address clinical, therapeutic (including pharmaco-dynamic and pharmaco-kinetic properties wherever relevant) and safety aspects of the healthcare interventions of interest, with a view to the identification and assessment of benefits and risks. Guidelines for best practice from healthcare associations and authorities must be taken into account when applicable.
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.
Significantly decreasing treatment related risk in the paediatric population (e.g. by researching adverse drug reactions, medical device deficiencies, etc.)
Establishing novel and/or more effective treatment schemes for healthcare interventions in the paediatric population
Validating benefits of novel and/or frequently used health interventions in the paediatric population
Type of action: Research and innovation actions