Feasibility assessment of neonatal studies and selection of investigator sites/ study centres: Points to consider

This PedCRIN guidance provides a structured framework for evaluating the feasibility of neonatal clinical trials and selecting investigator sites with the appropriate expertise and infrastructure to successfully conduct a study. It presents practical points to consider when assessing factors such as disease epidemiology, expected participant availability, study procedures, site capabilities, staffing, clinical expertise, research infrastructure, regulatory requirements and local operational processes that may affect trial implementation. The guidance supports investigators and sponsors in identifying centres that are capable of delivering high-quality neonatal clinical research while minimising operational risks.

Although developed for neonatal trials, the recommendations are highly relevant to paediatric and rare disease clinical research. Rare disease studies frequently depend on a limited number of specialised centres, require multinational collaboration to achieve recruitment targets, and involve complex study procedures that demand experienced investigators and appropriate infrastructure. The feasibility considerations described in this guidance—including evaluation of patient populations, site experience, operational capacity, ethics and consent processes, and local research capabilities—are directly applicable to many rare disease clinical trials beyond neonatology.

For trial management, this resource helps research teams make informed decisions about site selection, assess the likelihood of successful recruitment and study completion, and identify potential operational challenges before trial initiation. By supporting systematic feasibility assessment and the selection of experienced study centres, the guidance contributes to more efficient trial implementation, improved recruitment performance and higher-quality multicentre clinical trials. These principles are particularly valuable in paediatric and rare disease research, where appropriate site selection is often a critical determinant of study success.