Table 2.

Hurdles, timelines, and the added value of the NHs during the academic PoV trials.

Trial type	NH	Hurdles	Timelines	Added value of the NH
General seasonal	BPCRN	COVID-19 disruptions, IMP logistics, privacy adaptations, seasonal disruptions of disease	Approval in 2 months, first country outside of sponsor country; two sites opened by end of 2021	Efficient navigation during pandemic; expedited submission/approval; effective problem-solving
	Pedmed-NL	COVID-19 disruptions, staff shortages, contractual issues, local approval delays	One site opened by July 2022; first recruitment in March 2023	Close relationships with sites and trial support; enhanced trial preparation and coordination; effective budget negotiations; facilitated collaboration
Neonatology	BPCRN	Competing trial, COVID-19 disruptions, transition from paper to digital dossiers	Approval and site opening in 9 months	Bilingual staff; swift submission for neonatal population; knowledge of local trial staff and central coordination
	Pedmed-NL	Competing trial	Not eligible for participation	Early realization of ineligibility due to network knowledge
Rare disease with limited inclusion criteria	BPCRN	Low incidence in sites, upcoming introduction of high-efficacy medication availability	Reapproached in Q1 2021, sites and hub declined in 2 weeks	Quick reassessment of potential sites; understanding of local clinical needs and context
	Pedmed-NL	Sponsor constraints, NCA and EC package sponsor approval delays	Approval in 21 months	Mediation between sponsor and sites; coordination for reimbursement after trial termination