The Biostatistics Laboratory provides methodological support for the design, conduct and analysis of data from Phase II and III clinical trials conducted at the Aldo and Cele Daccò Clinical Research Centre.
The main areas of study are chronic kidney diseases of diabetic and non-diabetic origin, kidney transplantation, dialysis, some rare diseases and, more recently, the treatment of COVID-19. The laboratory is involved in systematic reviews and collaborates in the development of meta-analyses promoted by international networks. It also uses advanced statistical models for the purposes of identifying prognostic factors for predictive models of subsequent clinical events, jointly analysing repeated measures of a given biomarker and survival data, and, where randomisation is not possible, appending one or more similar controls to each treated subject using statistical matching procedures.
Activities
• Final analysis of data from a clinical trial with a cross-over design called TOOL. The study, which involved patients with autosomal dominant polycystic kidney disease, demonstrated the efficacy of combination therapy with tolvaptan and octreotide-LAR compared with tolvaptan and placebo, with regard to glomerular filtrate and total renal and cyst volume
• Final analysis of data from a clinical trial with parallel-arm design called CRESO 2. The study, which involved obese patients with type 2 diabetes, showed that a calorie-restricted diet improved glomerular hyperfiltration
• Final analysis of data from a clinical cohort study with pairing called COVER 2. The study showed that early treatment of COVID-19 patients at home by their family physicians, according to the proposed recommendation algorithm, almost completely prevented the need for hospitalisation
• Final analyses fora prospective cohort clinical study involving 204 adult patients with membranous nephropathy. A difference in how male and female patients responded to rituximab therapy was observed; specifically, a larger number of partial and complete remissions were observed in female patients than in male patients
• Collaborated in developing a Bayesian meta-regression aimed to produce a combined assessment of changes from baseline in the albuminuria/creatinuria ratio and in glomerular filtrate trends. The study showed that the combined use of the above two surrogate endpoints, usually used individually, improves predictions regarding treatment effects with regard to subsequent clinical endpoints.
