Collaboration in neonatal and paediatric clinical pharmacology: involving medical students within (inter)national clinical trial networks

Introduction Between 50 and 96% of drugs prescribed to neonatal and paediatric populations are used off-label, creating a clear need for clinical pharmacology studies and subsequent labelling. Key to the successful future of paediatric drug development is creating a collaborative community of professionals focusing on neonatal/paediatric clinical pharmacology. Offering the opportunity for students to participate in a pan-European project such as conect4children (c4c) may enhance their enthusiasm for the field of neonatal/paediatric clinical pharmacology. The primary objective of the concept is to evaluate the motivations and barriers medical students encounter when volunteering in neonatal/paediatric clinical pharmacology and to evaluate the role their tutors play. Methods A systematic approach to volunteering in this area includes the definition of learning objectives and activities. Conceptual subjects are students and tutors of undergraduate medicine, in the 4th - 6th year, with interest in the field. The c4c Young Investigators Community (YIC) will be used as a platform to interact with established investigators in order to reach the primary objective. Results Student activities include taking online training courses such as Good Clinical Practice (GCP), translating documents into local languages, actively participating in national/international meetings, and communicating with other healthcare professionals and/or the general public. Investing into involving a younger generation also aids the sustainability of international and clinical trial networks. Conclusions The concept of medical students volunteering in neonatal and paediatric clinical pharmacology is feasible, motivating for tutors and supports clinical