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 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.

Following FDA Reviewer Guidance principles and ICHE3 guidelines, JMP Clinical enables analysis of event rates and estimation of risk over time, while helping you rapidly explore events, such as medical history, disposition and adverse events, as well as possible differences in subgroups. You can easily select these subgroups with Distribution dashboards that summarize by age, sex, race, treatment group and site.

Incidence screens, the principal safety analyses for adverse event identification, perform a Cochran-Mantel-Haenszel test, yielding volcano plots of multiplicity-adjusted p-values by risk difference, relative risk or odds-ratio. View the demo (11:44).

JMP Clinical utilizes multiple testing methods, mitigating the risk of over-reporting adverse events. For a more in-depth discussion of these features, please see “A Primer on JMP Clinical Incidence Screens.” The MedDRA hierarchy allows examination of verbatim terms, preferred terms, higher level terms, higher level group terms, as well as Standard MedDRA Queries, to help you discern adverse event patterns across treatment groups.

With JMP Clinical, you can determine the onset of an adverse event and its outcomes with time-to-event analyses and resolution screening, respectively. View the demo (03:36). JMP Clinical facilitates time windowing in most analyses, and the AE Resolution Screen lets you monitor adverse event outcomes during a specified time window. The Severity ANOVA helps clinicians to confirm whether severity differences are of concern in the safety population.

JMP Clinical equips medical reviewers with analyses for both measures of central tendency and outlier detection so that they can quickly identify potentially harmful symptoms that develop during the clinical trial.

Nearly all of the visualizations recommended in the FDA Reviewer Guidance are available in JMP Clinical without any programming. Distribution displays, box plots, shift plots, time trends, scatterplots and bubble plots can all be leveraged to explore any Findings domain of interest. Interactive bubble plots show the rate of change for multiple lab tests, measuring trends over time across treatment groups or other categories. Baseline ANOVA analysis measures the change from baseline on the trial via box plots or shift plots, a prescribed analysis from the guidance documents.

The Findings time-to-event process permits you to use value cutoffs to arbitrarily define an event from any Findings domain before performing an analysis. JMP Clinical evaluates liver toxicity, a primary safety focus of clinical trials, by identifying subjects who meet the Hy’s Law criteria described in the Drug Induced Liver Injury Guidance document set by the FDA.

Automated patient profiles and patient narratives reduce the time and complexity of creating output for review and submission to the FDA. JMP Clinical lets you instantly generate patient profiles for an individual or group of subjects, simply by selecting subjects from a Hy’s Law graph, box plots or shift plots, to name a few. Reviewers and medical writers can 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. Patient profiles are customizable, displaying data from any combination of the core safety domains. Once the reports are tailored, they can be printed in PDF or RTF, making for straightforward communication of findings among review groups. View the demo (12:10)

JMP Clinical can also compose a configurable patient narrative for each subject who experienced a serious adverse event during the clinical trial. Reviewers and medical writers enjoy the speed of this programmed process, using the write-ups as a starting point for the final patient narratives compiled in the Clinical Study Report (CSR) required by the FDA.

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.

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.