Developer Tutorial: New Patient Safety Reports in JMP Clinical

This session is for JMP Clinical users and anyone from the clinical trials community interested in new reports relating the timing of adverse events to patient safety.

Do you run clinical trials or work at a sponsoring or regulatory agency supporting clinical trials? Is patient safety related to new or improved medications critical to your organization’s success? Do you need to understand the possible benefit-risk profiles of novel therapies?  Are you challenged to identify events or medications that tend to occur simultaneously, or the overlap of medications being used while patients are experiencing Adverse Events (AEs)?

Because AEs occur spontaneously and over time, designing the most appropriate analysis in advance is challenging and nearly impossible. Their temporal relationships to treatment, concomitant medications, or death provide additional challenges to understanding patient safety.

JMP Clinical 19 includes new features to further our understanding of the benefit-risk profiles of novel therapies. In this Developer Tutorial, JMP Principal Research Fellow, Richard Zink, demonstrates three key new reports that consider the timing of adverse events as it informs our understanding patient safety.  He shows how to use and interpret:

• Recurrence - Understand the safety of events that occur repeatedly within patients over time.
• Co-occurrence– Examine all observed pairs of AEs and medications to describe the extent of their overlap in time.
•  Nearby Occurrences - Select reference occurrences of interest (AEs, concomitant medications, or death) and find nearby occurrences that appear within time windows defined around the start or stop dates of the reference occurrences. Alternatively, identify nearby occurrences as those events that have any overlap in time with the reference occurrences.