Global ALS/MND "big data" collaboration environment in a post-PRO-ACT era
published: July 21, 2017, recorded: May 2017, views: 2
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Platforms for global large-scale phenotyping allow investigators to collaboratively share clinical datasets, develop disease progression models and identify disease sub-populations and link clinical data to bio-, image-banks, WGS files, and omics to bringing ALS/MND into the Age of Precision Medicine and Big Data. While PRO-ACT database proved its efficiency as a de-facto reference set with tens of publications, several disease models and staging systems, its usefulness for disease modeling is somewhat limited. It is essential to identify new clinical datasets and utilize common approaches to data collection, integration, de-identification, sharing and distribution and incentives for Data Contributors. In NeuroBANK™, an accelerated patient-centric platform and environment for prospective clinical research, PALS’ information is linked across studies, locations and modalities. CDEs, SOPs and Neurological Global Unique Patient Identifier (NeuroGUID) technology lead to accelerated studies' review, approval, deployment and enrollment, while preserving PALS’ privacy. Standardized ICF language facilitates information sharing/data aggregation from multiple projects. Patient Portal allows integrating patient-reported outcomes (PROs) in Pooled Resource Open-Access Clinical Research (PRO-ACE) platform. Data from observational studies, retrospective clinical assessments, population registries and clinical datasets are eligible for inclusion of Data Use Agreements (DUAs). Defining data sharing terms are executed by Data Contributors who obtain ERB/IRB approvals and become members of PRO-ACE Consortium with benefits ranging from securing authorship to first-access rights. Cleaned, de-identified, harmonized datasets are merged into PRO-ACE Dataset available for open-access distribution for secondary analyses. International Data Access Committee reviews requests and grants access. Results: NeuroBANK™ provides CDEs, data management, user training and certification, and help desk. 22 concurrent prospective research projects (6,000+ total enrollment goal), 200+ users from 94 research sites/17 countries capture data and track biofluids, tissues, cell lines, GWS files, images, omics and PROs in NeuroBANK™. Standard DUAs, MTAs, SOPs, and ICFs are implemented. NeuroBANK™/PRO-ACE data are devoid of placebo effects and clinical trial selection bias. Conclusions: Available platforms and developed approaches allow for truly global collaboration.
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