Clinical Research & Clinical Trials

Biography

Biography: Donato Bonifazi

Abstract

Conducting clinical research in paediatrics poses many distinctive challenges that need to be considered when planning, managing and delivering clinical trials and that require specific competences and infrastructure. Biological samples, like blood and blood fraction, tissue, urine and saliva/buccal cells, are commonly used in biomedical and clinical research. Analyses from biological samples provide key outputs in clinical trials, as for pharmacokinetic, safety and efficacy evaluations of investigational medicinal products. Consequently, it is essential that sample collection, management, storage and analysis are performed according to high standards. This is even more important in paediatrics considering that blood sampling may be difficult, the number of samples is usually limited, especially in newborns , and all the efforts should be made to minimise sample volumes. Ethical and regulatory requirements (consent, assent and data protection, particularly with respect to long-term storage), training and facilities required for samples collection and storage are relevant to grant a proper management and use of biological samples. Considering the crucial role of biological samples and the challenges they pose for researchers planning and conducting paediatric clinical trials, in the context of the PedCRIN project a tool (checklist) to support the management of biological samples and associated data in the context of paediatric clinical trials has been developed. This checklist will favour the adherence to the recommended standards and will allow to release an easy-to-use tool to help the investigators, sponsors and other research actors involved in paediatric clinical trials in the management of bio-samples.