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Jul 21, 2014

New Product JMP Clinical Streamlines Drug Development

Geoffrey Mann, PhD, JMP Product Manager for the health and life sciences industry, helped create JMP Clinical software, the newest member of the JMP product family. Released today, JMP Clinical is designed for medical reviewers, epidemiologists, data monitors, biostatisticians and biometrics groups engaged in analyzing safety data from clinical trials.

In designing JMP Clinical, Mann drew on his experience as a member of the Clinical Data Interchange Standards Commission (CDISC), where he participates on the CDISC Analysis Data Model (ADaM) Team as the metadata team lead and is a member of the CDISC Integrated Data Pilot Team.

Here, he offers insights into developments that motivated release of this new offering and describes some of the groundbreaking capabilities in JMP Clinical.

What is JMP Clinical?

JMP Clinical is new software from SAS that streamlines the drug development process. It’s a customized tool for sophisticated analysis of safety review data collected during clinical trials of new prescription drugs. Like all JMP products, JMP Clinical has data visualization capabilities and a user-friendly environment. This means that medical reviewers – many of whom are physicians with little training in statistics – can more easily discover patterns and hidden trends in data on adverse events, concomitant medications, lab results and patient profiles.

Many pharmaceutical organizations are beginning to adopt globally recognized CDISC standards for data formats and terminology used in clinical trials. JMP Clinical uses SDTM data – the most mature CDISC data standard – and is one of the first tools to use the new ADaM data standard for analysis and reporting.

What kind of organizations will use JMP Clinical?

Any organization that is directly or indirectly supporting the submission of a new drug application to the FDA will benefit from using JMP Clinical. That includes developers of medical devices and diagnostic tests, as well as pharmaceutical companies that are producing new vaccines and prescription drugs.

What makes it special?

JMP Clinical’s menu of analytics follows FDA reporting guidelines in logical sequence, with customized dialogs for various types of users. All it requires is a path to your data. Then intuitive dashboards let users quickly create summary views with drill-down capabilities that take them to results for individual trial subjects via patient profiles. So even users with little statistical training can get started quickly.

A unique feature of JMP Clinical is its ability to cluster events, findings and interventions. Users pick an individual cluster and can then infer potential causal relationships by analyzing the strength of the correlations they share. Another distinctive feature of JMP Clinical is its use of multiple testing methods to reduce false-discovery rates. This is powerful because it mitigates the risk of over-reporting adverse events in a trial.

Why did JMP venture into clinical trials?

Clinicians prefer visual tools that let them have easy access to their data. Statisticians know about powerful analytical tools like SAS but may not know the value of JMP’s visualization capabilities. JMP Clinical allows the two groups to communicate more easily by letting them use the same set of tools.

JMP is already the tool of choice for medical reviewers – more than 40 percent of FDA reviewers prefer JMP. SAS is already the standard analysis and reporting tool for biostatisticians in the pharma industry. So we already had the technological expertise and industry knowledge needed for development of this customized product. Because we use CDISC standards as the basis for analysis and reporting, we are helping clinicians move into the modern review environment.