Insightful Solutions for Statistical Modeling and Graphical Analysis of Safety Data in Clinical Trials

Presented: Thursday, January 17, 2008
Speaker: Dr. Michael O'Connell, Director Life Science Solutions, Insightful Corporation

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Drug safety issues continue to drive headlines up and stock prices down. The past 12 months have seen failure of high profile drugs in late stage clinical trials (e.g. torcetrapib), withdrawal of drugs from market (e.g. Trayslol) and black-box warnings resulting from academic journal articles (e.g. Avandia).

The Insightful Clinical Graphics™ and Insightful Clinical Review™ Solutions are geared towards rapid and accurate analysis and reporting of safety data. They incorporate targeted statistical and graphical analyses for AE’s, labs and vitals; in alignment with FDA safety guidances e.g. the recent Oct 07 guidance on drug induced liver injury (DILI). The Solutions are designed to address sparse data and multiple endpoints issues with safety data.

Insightful Clinical Graphics provides a standard library of statistical graphics for safety data analysis, and enables simple sharing and re-purposing of graphical analyses in user-friendly interfaces and workflows. Built on the S-PLUS Enterprise Server, Insightful Clinical Graphics is scalable to large groups of statisticians, clinicians and programmers.

Statistically sound safety data analyses, and their resulting interactive graphical/tabular review and report outputs, have immense value for pharmaceutical companies, drug safety monitoring boards and regulatory agencies such as the FDA. We invite statisticians, clinicians and management across the industry to join this webcast, and this movement towards better safety data analysis, clinical review and study reporting.