JMP® Clinical

JMP Clinical permits clustering of all adverse events, interventions and findings across safety domains. Incidence screens of concomitant medications allow clinicians to identify drug-drug, drug-demographic and drug-disease interactions.

The new Exposure Summary process identifies differences in dose and duration of exposure across treatment groups, providing context for all downstream analyses. JMP Clinical includes options to choose the number of dosing groups and the duration of the time window.

Space-constrained displays of visual analytics show the effects of interventions over time. 

JMP Clinical follows FDA Reviewer Guidance principles and ICHE3 guidelines and enables analysis of event rates and estimations of risk over time. It lets you explore possible differences in subgroups and identify risk factors linked to serious events. You can easily estimate adverse event frequency and count information with the highly visual mosaic plot.

Using industry-standard or customized views, you can select any serious and/or severe adverse event and drill down for an in-depth view of subject details. An enhanced workflow adds subject clustering and subject filtering to existing analysis options for patient profiles.

The software follows industry-standard analysis methods to measure time-to-event for any adverse event in a clinical trial. You can effectively screen all Standard MedDRA Query (SMQ) terms to discern adverse event patterns across treatment groups. Following analysis, you can generate multiple reports that provide a comprehensive evaluation of risk information based on predictive factors.

Determining treatment compliance and establishing baseline values for lab measurements is important for all clinical reviewers. Often these data provide the means to determine both efficacy and safety evaluations. JMP Clinical supports baseline determination, shift plots and box plots for all labs, vital signs and electrocardiograms as well as more specific analyses such as Hy’s Law Screening. The Data Filter tool makes it possible to subset distributions of these Findings domains by demographic and derived subject level data.

Sophisticated graphics in JMP Clinical make it easy to spot and select one or more outlying laboratory values, and then drill down quickly to subject-level details using patient profiles.

Baseline ANOVA analysis measures the change from baseline for any specific laboratory test in the trial. Interactive bubble plots show the rate of change for multiple lab tests, measuring trends over time across treatment groups or other categories of interest. The default view for bubble plots in JMP Clinical uses Hy’s Law analysis to assess hepatotoxicity, a focus of the US Food and Drug Administration’s safety review.

Subject clustering and profiling

Nearly all analyses in JMP Clinical allow you to cluster subjects, profile subjects or apply subject filters. Subject clustering allows you to look for patterns across all safety domains and easily identify similarities within a subset of subjects, then apply filters that focus all future analyses only on the selected subset of individuals.

A new feature in JMP Clinical 3 makes it easier to compare information about multiple subjects by overlaying their profiles on a single time line. Reviewers and medical writers can now also record and save unstructured text about any subject or group, noting, among other things, cases of death, serious adverse events and reasons for discontinuation. You can furthermore customize patient profiles, displaying data from any combination of the core safety domains.

The patient profile graph shown here reveals the onset of interventions, events and findings during the trial.

JMP Clinical now facilitates time windowing in most analyses, making it easy for you to compare interventions, events and findings for two or more time windows.  You can dynamically plot data over time and/or create animations with bubble plots.

Medical reviewers who want to compare the resolution of adverse events within specific time windows can use AE Resolution Screen, also new in JMP Clinical 3.

In the bubble plot here, time windows show the change in significance and relative risk for all adverse events and concomitant medications for each day of the trial. The significance (-log p) is on the Y-axis and the relative risk is on the X-axis. Bubble size indicates the frequency of occurrence and a numeric character denotes the study day. Adverse events are in red and concomitant medications are in blue.