Level: Intermediate
Reporting, tracking and analysis of adverse events that occur in subjects is an important part of the safety evaluation of clinical trials. Many pharmaceutical companies and the regulatory agencies to which new drug applications are submitted use JMP Clinical to help with the evaluation of these adverse events. Biometric analysis programming teams may create static tables, listings and charts for medical monitors and reviewers.
This leads to inefficiencies, such as doctors not being able to directly interact with the adverse event summary to understand the medical impact of the occurrence of a particular event. But even producing a simple count and frequency distribution of adverse events is not always easy. This presentation will focus on the primary reports in JMP Clinical: adverse event count, frequency, incidence and time to event. JMP Clinical's out-of-the-box reporting capabilities make it easy to perform fully dynamic adverse event analysis, even when you're performing complex calculations that rely heavily on JMP formulas, data filters, custom scripted column switchers and virtually joined tables.
Kelci Miclaus is manager of JMP Life Sciences R&D, developing statistical capabilities for JMP Genomics and JMP Clinical software. She joined SAS in 2006 and earned her PhD in statistics from North Carolina State University.
