- New Features
- Explore & Analyse
- Patient Reports
- Pre-Clinical & Post-Market
Simplify discovery in clinical trials
JMP Clinical software from SAS simplifies data discovery, analysis and reporting for clinical trials, bringing greater efficiency, accuracy and ease of use to studies of safety and efficacy data.
The software combines the industry-leading power of SAS® Analytics with the graphical flexibility of JMP, the longstanding tool of choice of medical reviewers at the US Food and Drug Administration. Its visual paradigm makes it easy for medical monitors, medical writers and biostatisticians to see and explore trends and outliers.
Designed in collaboration with medical officers, JMP Clinical provides workflows, templates and reporting tools customised for medical reviewers, medical monitors, medical writers, biostatisticians and data managers.
Clinicians without programming experience or statistical training can generate clinically relevant results. Advanced analysts enjoy effortless access to the statistical analysis options and code behind the graphics – a benefit not found in similar software tools.
By generating configurable patient profiles and patient narratives, JMP Clinical helps medical monitors and medical writers trim the time-consuming process of creating a Clinical Study Report.
New features benefit clinicians
JMP Clinical 4 makes it easy to combine interactive reports into a review package that simplifies collaboration between clinicians and biostatisticians, who can now share ad hoc reviews, safety workflows and other reports via emails, shared folders and clinical data repositories, including SAS® Drug Development. With a single click, clinicians can gain access to any report in the system. The simple user interface eliminates frustration and wasted time for medical officers who need access to the data but don’t want to learn a new system.
Another new feature in the software allows clinicians to create and save templates for customised patient profiles, tailoring the display of clinically relevant data for specific therapeutic areas. (See Patient Reports tab.)
Patient narratives created using JMP Clinical 4 reveal a richer story about each subject, showing results of lab tests and other selected findings against an event-driven timeline.
Designed in collaboration with medical monitors, summary dashboards in JMP Clinical enable clinicians to evaluate data from ongoing, blinded trials for safety issues with the click of a button, creating interactive reports of adverse events, concomitant medications, labs and vital signs with the ability to drill down to customised patient profiles and patient narratives.
JMP Clinical 4 supports all domains, including custom domains, for CDISC SDTM and SEND data models.
Trial results: see the full picture
During clinical trials, JMP Clinical links advanced analytics with exceptional graphics to present a comprehensive and detailed picture of trial results.
Medical monitors can evaluate data from ongoing, blinded trials for safety issues with the click of a button, creating summary dashboards of adverse events, concomitant medications, labs and vital signs with the ability to drill down to customised patient profiles and patient narratives. Monitors share these reports in PDF or RTF format with medical writers, who tailor the final study reports. At any point, biostatisticians can evaluate statistically significant differences due to age group, sex, race or site using sophisticated pattern discovery or predictive modeling analyses.
By using standard CDISC data – the format for clinical analysis and reporting preferred by the FDA – as well as standard reviewer guidances and standard visualisations, the software streamlines the exploration, review and submission of clinical trials data to the FDA.
JMP Clinical organises the review process, working behind the scenes to automate the analytics and reporting so reviewers have more time to interpret and understand the results.
The fluidity of movement between results for the entire trial and for specific subjects is a hallmark of JMP Clinical, and its visual paradigm speeds discovery, revealing trends and outliers that spreadsheets tend to hide.
JMP Clinical now supports all CDISC domains for safety and efficacy review – including customised domains. A simple Starter menu provides access to analysis results from any CDISC domain.
As one of the first tools that inherently understand ADaM data, JMP Clinical is a great option for clinicians and biostatisticians migrating into the modern review environment.
1-click patient profiles, narratives
Automated patient profiles and patient narratives reduce the time and complexity of creating output for review and submission both internally as well as to the FDA and other regulatory agencies. Along with summary dashboards of events, findings and interventions, these features enable medical officers to quickly generate hypotheses about particular groups or subgroups within the study population.
The new Review Builder app loads data and reports into a simple user interface, eliminating frustration and wasted time for medical officers who need access to the data but don’t want to learn a new system. With a single click, clinicians can gain access to patient profiles and narratives.
JMP Clinical lets medical officers instantly generate patient profiles for an individual or group of subjects simply by selecting subjects, and it displays clinical results visually, making it easier for nonstatisticians to understand. Patient profiles are customisable, displaying data from any combination of the core safety domains. Once the reports are tailored, users can save the view as a template or can print the report in PDF or RTF, making for straightforward communication of findings among review groups.
JMP Clinical can 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.
Compare interventions across groups
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. Incidence screens of concomitant medications and substance use allow clinicians to identify drug-drug interactions. Following FDA Reviewer Guidance principles and ICHE3 guidelines, with a focus on adverse events, JMP Clinical enables analysis of distributions, event rates and estimations of risk over time for blinded and unblinded data. Clinicians can easily select subgroups with Distribution dashboards that summarise by age, sex, race, treatment group and site.
Monitor events and outcomes
With JMP Clinical, you can determine the onset of an adverse event and its outcomes with time-to-event analyses and resolution screening, respectively. Various time-to-event analyses, such as Time To Discontinuation, are available with the click of a button. JMP Clinical facilitates time windowing in most analyses, and the AE Resolution Screen lets you monitor adverse event outcomes during a specified time window.
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. The bubble size indicates the total incidence of an event that occurs for both treatments combined. Select adverse events (bubbles) of interest to determine the frequency of co-occurrence in the study population using a Venn diagram.
JMP Clinical supports the MedDRA hierarchy, allowing examination of any term level, including Standardised MedDRA Queries, to help you discern adverse event patterns across treatment groups. The software also lets you compare the incidence of any of these term levels across the duration of the trial. For a more in-depth discussion of these features, download the complimentary white paper, A Primer on JMP Clinical Incidence Screens.
Quickly identify potential harms
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 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 visualisations recommended in the FDA Reviewer Guidance are available in JMP Clinical without any programming, including distribution displays, box plots, shift plots, time trends, scatterplots as well as change from baseline. In addition, our volcano plots offer a simplified but uniquely comprehensive view of relative risk data that shows changes over time.
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. An industry-standard scatterplot matrix displays Hy’s Law along with a mosaic plot to confirm the number of days subjects experienced elevated liver test measurements. Finally, a tabular report in the dashboard display shows the number of subjects who missed the laboratory tests necessary for Hy’s Law determination.
Visual discovery from the start
JMP Clinical now supports the SEND data model as well as STDM, allowing study directors and toxicologists to utilise the same standard visualisation and analysis for pre-clinical (non-clinical) studies.
Spontaneously reported adverse events are collected by regulatory agencies, pharmaceutical companies and device manufacturers to monitor the safety of a product once it reaches the market. These data are generally obtained from physicians, patients or from medical literature.
Because there is no measure of total exposure, spontaneously reported adverse events present a unique challenge. In order to identify potential safety signals, the rate at which a particular event of interest co-occurs with a given drug is compared to the rate this event occurs without the drug in the event database. This is referred to as disproportionality analysis. JMP Clinical now provides tailored dashboards to support disproportionality analysis.