PORTICO Clinical Trials Toolkit

The Portico Center Toolkit Modules are a comprehensive collection of practical resources, templates and training materials designed to support investigators, study coordinators and research teams in the operational management and conduct of clinical trials. Developed as part of the Portico initiative for paediatric musculoskeletal disease research, the toolkit provides practical guidance across multiple aspects of trial implementation, including participant recruitment and retention, informed consent, participant engagement, health literacy, diversity and inclusion, community engagement, and decentralized and hybrid trial approaches.

While the toolkit was developed in the context of paediatric musculoskeletal diseases, the principles and resources it contains are broadly applicable to clinical research in other paediatric conditions and rare diseases. Many of the operational challenges addressed—including recruitment of small and geographically dispersed patient populations, participant retention, effective communication with patients and families, accessible informed consent processes, and equitable access to clinical research—are common across rare disease trials regardless of the therapeutic area.

For rare disease clinical trials, the toolkit offers practical strategies to improve trial implementation by supporting participant-friendly communication, inclusive recruitment practices and participant-centred study conduct. These resources can help research teams reduce barriers to participation, enhance participant engagement and retention, and improve the overall quality and efficiency of trial delivery. As such, the Portico Toolkit complements methodological and protocol development guidance by providing practical solutions that can be adapted across a broad range of paediatric and rare disease clinical research settings.