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PRISM (Paediatric Clinical Research Infrastructure Service Model), funded by Horizon Europe, aims to strengthen multinational paediatric clinical research through infrastructure, operational expertise, and innovative clinical study support.

This two-stage call supports investigator-initiated paediatric clinical studies across a broad range of disease areas, excluding cancer and rare diseases. Selected projects receive direct operational support and end-to-end trial management services from the PRISM infrastructure.

Key features:

• Two-stage application process: Letter of Intent followed by Full Proposal.
• Supports pragmatic comparative effectiveness trials, optimisation studies, repurposing trials, and prospective observational studies.
• Studies must involve 3 to 6 countries across Europe and/or Canada.
• Maximum project duration: 30 months.
• Mandatory use of PRISM clinical operations and data management services.
• Additional support services available, including statistical analysis, decentralised trial elements, digital patient-reported outcomes, and GenAI-enhanced eCRFs.

Objective: To enable high-quality multinational paediatric investigator-initiated clinical studies by providing coordinated infrastructure services and operational support.

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• Investigator-initiated paediatric clinical study.
• Study population from birth to 18 years of age.
• Studies must recruit participants in 3 to 6 countries across the European Union, Norway, Switzerland, the United Kingdom, and/or Canada.
• A single non-commercial experienced sponsor is required.
• Sponsors outside relevant jurisdictions must appoint an eligible sponsor representative as specified in the call.
• Maximum 15 study sites per project (except cluster randomized controlled trials).
• Maximum study duration: 2.5 years (30 months).
• One primary outcome and a maximum of two secondary outcomes.
• Mandatory use of PRISM clinical operations and Data Management services.
• Selection of at least one additional PRISM service is expected.
• Eligible study types:
  • Pragmatic investigator-initiated randomised controlled trials.
  • Optimisation studies.
  • Repurposing trials.
  • Prospective observational cohort studies.
• Maternal-infant studies are eligible if the intervention targets the infant.

Out of scope:

• Commercial or industry-sponsored studies.
• Oncology studies.
• Rare disease studies.
• Basic research, pre-clinical research, and Phase I studies.
• Already running studies.
• Studies focused on transition from paediatric to adult care.

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In case of interest, please click on 'm'interessa' and we will contact you.