Data Management & Statistical Core

PROJECT SUMMARY – DATA MANAGEMENT & STATISTICS CORE The overarching goal of the Data Management & Statistics Core (DMSC) for the Partnership to Assess Viral and Immune Landscape Intersections with Oncology for People Living with HIV (PAVILION) is to provide comprehensive statistical design, data management, and analysis in support of conducting rigorous and

reproducible research by PAVILION investigators who are working to make strides in understanding the proportion of tumors whose etiology is attributable to the human papillomavirus (HPV) and Epstein-Barr virus (EBV) among people living with HIV in sub-Saharan Africa including such rare tumor types as anal, cervical,

conjunctival, oropharyngeal, penile, and vulvar cancers. The DMSC will be led by Dr. Michael Schell, who is exceptionally qualified in the design, analysis, and management of clinical and epidemiological studies. The DMSC has designed a robust yet flexible pipeline that builds upon the extensive infrastructure and long-term

international collaborations established by the PAVILION partnering investigators including those of the HIM1, BROADEN2, and EVRI3 international study teams. It leverages the extensive investment by Moffitt Cancer Center in biostatistics, bioinformatic, informatic, and computing capabilities as well as the depth and breadth of expertise

in the analysis of basic, translational, clinical, and large-scale cancer epidemiological studies to address project aims and build biostatistical capacity at Stellenbosch University (South Africa) and University of Zimbabwe, the PAVILION low- and middle-income country (LMIC) sites. Further, the DMSC will provide education and training

through lectures and mentorship in biostatistics to members and research staff, with the goal of building the expertise and capacity of the LIMC partner sites to lead future studies/trials. To achieve the overarching goal, the DMSC will provide statistical and analytical design, sample size determination, continuous monitoring of

accumulating data, statistical analysis of results, and manuscript development for peer reviewed publication. These activities are organized into the following Specific Aims: Aim 1: Provide statistical support for the design, conduct, and data management of planned and future PAVILION studies This aim provides support for the initial experimental design and data accumulation phases

of the proposed and future PAVILION projects. Aim 2: Lead statistical analysis of data produced by PAVILION studies for peer reviewed publication This aim provides hands on statistical support for analyzing downstream data produced by the proposed translational research projects and any pilot projects awarded through the Developmental Core.

Aim 3: Educate and train investigators at PAVILION LMIC partnering sites on biostatistical methods and resources needed for large scale epidemiological studies This aim provides hands on mentorship of two early career biostatisticians in South Africa and Zimbabwe to expand regional capacity in the rigorous design

and reproducible conduct of broad scale clinical and epidemiological studies in sub-Saharan Africa.