The Investigational Clinical Center: a clinical-supportive and patient-centered trial unit model. Ten years of experience through normal and pandemic times of a large pediatric trial center in Italy.

Evidence-based medicine relies on appropriately designed, conducted and reported clinical trials (CTs) to provide the best proofs of efficacy and safety for pharmacological and non-pharmacological treatments. Modern clinical research features high complexity and requires a high workload for the management of trials-related activities, often hampering physicians' participation to clinical trials. Dealing with children in clinical research adds complexity: rare diseases, parents or legal guardian reluctance to engage and recruitment difficulties are major reasons of pediatric trials failure.However, because in pediatrics many treatments are prescribed off-label or are lacking, well-designed clinical trials are particularly needed. Clinical Trial Units (CTUs) are indeed an important asset in the implementation of clinical trials, but their support to investigators is limited to administrative and non-clinical tasks. In this paper we present the model of the Investigational Clinical Center (ICC) of the Bambino Gesù Children's Hospital in Rome. The ICC includes clinicians supporting the Principal Investigators for clinical management of enrolled patients in compliance of Good Clinical Practice, the legal framework of Clinical Trials. Furthermore, we present 10 years' experience in pediatric clinical trials and how it has been affected in 2020 by the COVID-19 pandemic. The activity of the ICC has been evaluated according to specific metrics of performance. The ICC model offers a complete support, helping investigators, patients and their families to overcome majority of barriers linked to clinical research, even in time of pandemic. We propose this organization as an innovative model for total-supportive and patient-centered clinical trial implementation.

Practices and Perceptions of Family Centered Care among Healthcare Providers: A Cross-sectional Study in a Pediatric Hospital.

PURPOSE: This study aimed to: (1) investigate the extent to which Family Centered Care (FCC) principles are currently applied in clinical practice by healthcare providers working in inpatient units; (2) evaluate the extent to which FCC principles are perceived as necessary; and (3) examine the associations between FCC principles and socio-demographic and job characteristics of participants. Design and Methods A cross-sectional study was conducted at a large pediatric hospital using the Italian version of the FCC Questionnaire Revised (FCCQ-R). Univariate and multivariate analyses were performed. RESULTS: Data from 469 healthcare providers were used for analysis. Scores for the FCC daily practices (Current activities) were significantly lower than those for their perceived necessity (Necessary activities) (p < .001). Participants who were male, younger, with work experience >20 years and working in rehabilitation reported a significantly higher perception of Current activities of FCC than others. The older and the more educated the participants, the greater was the perceived necessity of FCC activities. Female, older, and less experienced participants employed by the hospital but not working in the rehabilitation setting perceived a greater gap between Necessary and Current activities of FCC. CONCLUSIONS: Scores for the Current and Necessary activities of FCC were lower than those reported in other studies. The lower scores in the Current activities and the significant gap can be due to organizational barriers or lack of skills, but the lower scores in the Necessary activities should be interpreted as a deficit of knowledge about FCC. PRACTICE IMPLICATIONS: There is a need for further education about FCC in order to increase its perceived relevance in clinical practice.