Santo Marsigliante

Phase I clinical trials represent a critical point in drug development because the investigational medicinal product is being tested in humans for the first time. For this reason, it is essential to evaluate and identify the Maximum Tolerated Dose (MTD) and the safety of the new compound. To mitigate the possible risks associated with drug administration and treatment, the European Competent Authority issued various guidelines to provide provisions and harmonize risk management processes. In the UK and Italy, particular attention should be paid to the Medicines & Healthcare Products Regulatory Agency (MHRA) phase I accreditation scheme and the specific rules set by the Italian Drug Authority through the AIFA Determination no. 809/2015. Both reference documents are based on the concept of quality risk management while conducting phase I clinical studies. Moreover, the AIFA determination outlines specific requirements for those sites that want to conduct non-profit phase I clinical trials. Indeed, the document reports peculiar activities to the “Clinical Trial Quality Team”, which is a team that should support the clinical site researchers in designing, starting, performing, and closing non-profit phase I studies. In this paper, we provide a general overview of the main European guidelines concerning the management of risks during phase I trials, focusing on the main peculiarities of the schemes and rules set by the MHRA and AIFA.

The feeling of pleasure during physical education (PE) could increase with physical activity participation and adherence for overweight children. While traditional games are known to have positive benefits on motor skill development, especially for children with poorer motor skills, and on the body mass of children, little is known about overweight children’s feelings of enjoyment when playing these games. To identify a program of physical activity appreciated by overweight children, we tested the effect of different activities, namely soccer (SO), shot put (SP), and traditional motor games (TMGs), on the feelings of pleasure for 28 overweight male children (aged 12.11 ± 0.63 years, BMI 26.89 ± 0.15 kg·m−2) participating in a 3-month cross-over study. To measure affective responses to exercises, we applied a validated feeling scale. The data were collected during eight PE lessons, which were organized for each cycle taught. Post hoc pairwise comparisons revealed a significant difference (Z = −3.195, p < 0.01) between the mean feeling score reported after the SO cycle (2.48 ± 0.41) and that after the TMGs (3.04 ± 0.32). A similar significant difference (Z = −3.304, p < 0.01) was found between the mean feeling scores reported after the SP cycle (2.27 ± 0.32) and the TMGs (3.04 ± 0.32). There was no significant difference between the mean feeling scores reported after the SO (2.48 ± 0.41) and SP cycles (2.27 ± 0.32). In conclusion, the findings of the present study suggest that TMGs may have beneficial effects on the feelings of pleasure for overweight children. Therefore, TMGs might potentially be considered as an alternative to conventional physical activities.