JMP JMP Pro JMP Genomics JMP Clinical JMP Add-Ins
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1 JMP FAMILY OF PRODUCTS: SOFTWARE FOR LIFE SCIENTISTS JMP JMP Pro JMP Genomics JMP Clinical JMP Add-Ins
2 CLINICAL TRIAL DATA REVIEWS Randomized clinical trial remains the gold standard for evaluating efficacy of an new intervention Safety profile assessment critical for trial success Safety analysis comes with several challenges Numerous endpoints measured repeatedly Detection of rare events (drug-induced liver toxicity) Limited studied population Limited understanding of biological mechanisms and pathways
3 EFFICIENT MEDICAL/SAFETY REVIEWS NEEDS Accelerated safety reviews Dynamic visualization coupled with tables and reports Leverage data standards (CDISC) Statistically-driven analyses with drill-down and swim-up capabilities Centralized electronic data review coupled with tools that clinicians, data monitors, and biostatisticians can employ
4 JMP CLINICAL LEVERAGES STANDARDS IN REVIEW GENERATION Desktop application with unique combination of JMP and SAS Software Point-and-click, interactive graphical interface All analyses/reports built by leveraging SDTM/ADaM (CDISC) standards Build Clinical Reviews for variety of consumers: Medical Monitoring Signal Detection Data Integrity Risk Based Monitoring Patient Profiles and semi-automated Adverse Event Narratives Open system of SAS programming macros and JMP Scripts to allow for customization
5 NICARDIPINE: EXAMPLE BACKGROUND Nicardipine hydrochloride is a medication used to treat high blood pressure and angina. It belongs to the class of calcium channel blockers. Nicardipine was used in a double-blind clinical study to treat subarachnoid hemorrhage (bleeding between the brain and tissues that cover the brain) The study was a two-week trial of 906 patients assigned to one of two treatment arms (intravenous nicardipine or placebo) All subjects were hospitalized Delayed cerebral vasospasm was primary endpoint Haley et al. (1993)
6 MEDICAL MONITORS/REVIEWERS/CLINICIANS/MEDICAL WRITERS: CENTRALIZED MEDICAL MONITORING TOOLS
7 MONITORING: DEMOGRAPHICS (DM) Assess patient characteristics Interactive graphical and tabular displays
8 MEDICAL SIGNALS: ADVERSE EVENT (AE) MONITORING Count/Percent of AE occurrence by treatment group or other demography characteristics
9 MEDICAL SIGNALS: POTENTIAL DRUG-INDUCED LIVER INJURY Application of Hy s Law combined with statistical trends in relevant laboratory test elevations
10 PATIENT PROFILES ON SELECT SUBJECTS OF INTEREST
11 MEDICAL WRITERS: ADVERSE EVENT NARRATIVES Any serious adverse event/hospitalization/death requires a written narrative JMP Clinical delivers semi-automated patient adverse event narratives Includes a framework for creating flexible templates
12 MEDICAL AND BIOMETRIC: ANALYTIC VISUALIZATION OF FINDINGS
13 CONCLUSIONS Statistically-driven, dynamic data visualization necessary for efficient clinical review Data standards allow for automated analyses that enable clinicians, data monitors, data managers, and statisticians Reports summarized are not comprehensive of JMP Clinical capabilities
14 THANK YOU! QUESTIONS?
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