The Critical Path for Alzheimer’s Disease (CPAD) Consortium: A platform for pre‐competitive data sharing, standardization, and analysis to support quantitative tools for AD drug development

Abstract Background The primary objective of the Critical Path for Alzheimer’s Disease (CPAD) consortium, a pre‐competitive consortium Institute, is to promote, support, and manage data knowledge sharing from Alzheimer disease (AD) drug development stakeholders. Since 2019, CPAD has embarked on new initiative acquire fluid imaging biomarker‐rich sources novel tools quantify progression across AD continuum. Method Patient‐level contemporary Phase2/Phase3 clinical trials observational studies acquired through formal contribution agreements within CPAD, curated in collaboration with contributors, standardized common structure terminology, input into relational model (RDM) tool generate analysis subsets. Data standardization being accomplished using Clinical Interchange Standards Consortium (CDISC) standards. RDM was developed open‐source software R converts CDISC ready files quantitative analyses user defined keys, i.e. unique identifying variables extracting information. includes front‐end interrogator that provides users versatile capabilities visualize tabulate data. Result As October 2020, CPAD’s database (https://codr.c‐path.org/) contains 41 studies, standards, which three datasets were used Four additional recently are standardized. Execution Contribution Agreements (DCAs) progress two rich key biomarkers. Nine prioritized targeted acquisition. currently transform subsets containing patient demographics (age, sex), biomarker information (Aβ 40/42), outcome assessments (Clinical Dementia Rating Scale – Sum Boxes). Conclusion acquisition platform stimulating efforts advancing development. Previously tools, including regulatory endorsed trial simulation tool, help optimize design advance AD.