Across 488 paediatric Phase 3 trials, the dataset contains 9,879 trial-level planned sites and 98,650 planned participants. Site leadership is concentrated in major children’s hospitals and university systems: Hospital Sant Joan de Déu Barcelona participated in 114 of 488 trials (23.4%), followed by Assistance Publique Hopitaux de Paris with 108 trials (22.1%) and Hospital Universitari Vall d’Hebron with 101 trials (20.7%). Country deployment is also concentrated: Spain, France, Germany, Italy, and Poland account for 7,095 of 10,041 country-authorized site slots (70.7%).
The top 10 normalized sites account for 878 of 9,381 unique site-trial participations (9.4%). The leading site, Hospital Sant Joan de Déu Barcelona, appears in 114 of 488 trials (23.4%).
Pediatric Phase 3 feasibility in Europe is not purely country-driven; it depends on recurring high-volume children’s hospitals and university networks. Spain has five of the top 10 sites, making it the strongest single-country source of repeat pediatric Phase 3 site leadership in this cohort.
Across 10,041 country-authorized site slots, Spain contributes 1,692 sites (16.9%), France 1,641 (16.3%), Germany 1,385 (13.8%), Italy 1,367 (13.6%), and Poland 1,010 (10.1%). Together, these five countries account for 7,095 of 10,041 site slots (70.7%).
For pediatric Phase 3 startup planning, the core European country set is clear: Spain, France, Germany, Italy, and Poland dominate site volume. Smaller countries still matter, but primarily as specialist or disease-specific additions rather than the backbone of broad pediatric recruitment.
Country-level planned participant allocations sum to 77,389. France accounts for 15,838 participants (20.5%), Germany for 11,677 (15.1%), Spain for 9,880 (12.8%), Poland for 9,503 (12.3%), and Italy for 8,091 (10.5%).
France is slightly behind Spain on site-slot volume but leads on planned pediatric participant allocation. Denmark and the Netherlands have smaller site footprints but higher participants per site, suggesting a more concentrated recruitment model in selected trials.
Using the primary listed therapeutic area, oncology accounts for 1,912 of 9,879 trial-level sites (19.4%) and immunology for 1,891 (19.1%). The largest disease-specific site clusters are atopic dermatitis, ulcerative colitis, systemic lupus erythematosus, type 1 diabetes, and moderate to severe plaque psoriasis.
The site map is split between high-prevalence pediatric immunology/dermatology programs and specialist oncology, haematology, nephrology, and rare-disease networks. For sponsors, this means the strongest countries are not enough; disease-specific site depth determines whether broad country activation translates into realistic enrollment capacity.
Small molecule trials account for 4,542 of 9,879 trial-level planned sites (46.0%) and 215 of 488 trials (44.1%). Combination or multi-modality trials account for 2,006 sites (20.3%), followed by monoclonal antibody trials with 1,778 sites (18.0%).
The pediatric Phase 3 site market is still anchored in conventional development modalities, especially small molecules and monoclonal antibodies. Advanced modalities are present, but they represent a much smaller share of site deployment and are more likely to require narrower specialist networks.
The highest-probability pediatric Phase 3 site strategy starts with Spain, France, Germany, Italy, and Poland, then layers disease-specific centers from the top site list. For broad pediatric programs, Spain and France provide the deepest site footprint; for participant allocation, France and Germany carry the largest planned recruitment burden.
A trial participation means one site appearing in one paediatric Phase 3 trial. A country-authorized site slot means one planned site counted within a country record. Modality groups are mutually exclusive: single-modality trials are grouped by their listed modality, while trials with more than one listed modality are grouped as combination / multi-modality.