JMP® Clinical 3, just released by business analytics leader SAS, offers new ways to interactively explore safety data in clinical trials, streamlining the review process for all types of clinical researchers. Combining the visual exploration capabilities of JMP with the statistical rigor of SAS® Analytics, JMP Clinical eases the migration from a static to a dynamic review environment. It sets itself apart by offering effortless access to the statistical details behind the graphics.
Subject clustering, new in version 3, lets researchers look for patterns across all safety domains and identify similarities within subsets of subjects. Time windowing, also new, makes it easy to compare interventions, events and findings for two or more time periods. A simplified Clinical Starter menu helps users easily select specific reports and analyses for dynamic visual exploration.
"JMP Clinical is the first sophisticated clinical data analysis product I have seen that vastly reduces the time it takes research clinicians to discover and confidently characterize potentially significant treatment emergent safety issues,” said Mark Williams, Vice President and CIO of Applied Clinical Intelligence of Bala Cynwyd, PA. “It is a very valuable tool for our work in clinical trial patient safety monitoring."
A menu-driven desktop follows US Food and Drug Administration (FDA) reporting guidelines in logical sequence. JMP Clinical then works behind the scenes to automate the analytics and reporting from standard Clinical Data Interchange Standards Consortium (CDISC) data, the global standard for clinical analysis and reporting.
Interactive dashboard displays let clinicians create sophisticated visual summaries of events, findings, and interventions, and then zoom and filter through the data to explore details. Researchers can display safety and efficacy data in both industry-standard visualizations and novel graphics.
Because medical reviewers and biostatisticians can utilize the same tool for their distinct roles in a clinical trial, JMP Clinical facilitates communication between internal review groups -- medical reviewers, epidemiologists, data monitors, biostatisticians and biometrics teams -- and later between sponsor organizations and FDA reviewers.
Geoffrey Mann, JMP Product Manager for health and life sciences, is a CDISC member and metadata team lead on the CDISC Analysis Data Model (ADaM) Team. He also is a member of the CDISC Integrated Data Pilot Team.
"Many pharmaceutical organizations are beginning to adopt globally recognized CDISC standards for data formats and terminology used in clinical trials," he explained"JMP Clinical uses SDTM [Study Data Tabulation Model] 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."
A trusted heritage
JMP Clinical combines two of the most trusted names in life sciences analytics. JMP is the tool of choice for more than 40 percent of medical reviewers at the FDA. SAS is the standard analysis and reporting tool for biostatisticians in the pharma industry.
About JMP and SAS
JMP is a business unit of SAS, the leader in business analytics software and services, and the largest independent vendor in the business intelligence market. Through innovative solutions delivered within an integrated framework, SAS helps customers at more than 45,000 sites improve performance and deliver value by making better decisions faster. Since 1976 SAS has been giving customers around the world THE POWER TO KNOW®. The Power to Know® .