Core C: Data Management, Biostatistics and Modelling

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CORE C. DATA MANAGEMENT, BIOSTATISTICS AND MODELLING SUMMARY/ABSTRACT ASPREE maintained excellent data quality (99.6% accuracy) and performed crucial biostatistical analysis for a vast quantity of data (~26 million data values) collected as part of the ASPREE Clinical trial. This Core will build on the success of ASPREE by expanding capability, accessibility and methodological reach. It will implement and maintain a sophisticated technology platform to support: i) in-field data collection (the focus of Core A); ii) facilitate the capture of clinical events and documents (Cores A & B); iii) support adjudication of clinical events (Core B); iv) provide storage and analysis of clinical images and biospecimen data (Core D); v) support linkage with national and state data repositories (Admin Core); vi) undertake linkage of participant measures and clinical data (Core A & B) with analysis-ready biospecimen (Core D) and genomic (Core E) data; and vii) support study administration and governance (refer to Figure 1 in Research Strategy). Core C will also develop a hub of biostatistical and modeling expertise to support the complex analysis of longitudinal data on disease and aging processes across Projects 1-3 of the U19. Specifically, this Core will apply state transition models to disentangle transitions of participants from being cancer-free to various cancer states, including death from cancer, with a key focus on the effect of long-term LDA use; complete continuous biomarker and health measure tracking to analyze trajectories of cognitive change; develop prediction models for Alzheimer’s disease risk and cognitive resilience, specific to older people, incorporating lifestyle, health, genomic and biomarker data to analyze cognitive decline; conduct continuous biomarker tracking analysis to analyze changes in score-based measures of health to investigate the development and progression of frailty and the relationship between frailty and disability; and employ multi-state time-to-event models to analyze complex disease pathways for disability. The impact of findings will be explored through projection modeling, and young investigators will be trained in best practice data management, data science, biostatistics and modeling. The activity of Core C is essential for the exploration of outcomes related to cancer, Alzheimer ’s disease and disability. Consequently, the activity of Core C is fundamental to addressing the research Aims for this U19.