JMP Clinical Perspectives – From Medical Reviewer (past) to Clinical Operations (present) to Clinical Data Science and Global Safety (future)
Geoffrey Mann, Product Manager, JMP Division, SAS Institute Inc.
This session will include a history of enhancements to JMP Clinical. With a focus on safety from the perspective of medical monitors and reviewers, we will look at Amit and other graphs in papers that help standardize the visualization of clinical trial safety. Interactive graphs and tables combined with table elements from ICHE3 and FDA reviewer guidance allow for many subgroups to be created when displaying adverse events, laboratory tests, and medication status. TransCelerate BioPharma Inc. and our own Richard Zink have integrated statistical central monitoring methods, including risk-based monitoring, to provide methods that help determine the integrity (data quality) of sites and patients in clinical trials. These methods are continually being improved, and some examples will be presented. At the end of the presentation, we will also discuss how we support clinical data scientists who help prepare content for scientific journals, and global surveillance teams who create regular safety update reports.
