KDnuggets News 05:04, item 5, Courses

KDnuggets : News : 2005 : n04 : item5

Courses

From: Kim Kelly
Date: 9 Feb 2005
Subject: Insightful webinar: Safety Data Analysis and Reporting Using S-PLUS� and Insightful MinerT, March 10, 8 am PT

Safety Data Analysis and Reporting Using S-PLUS� and Insightful MinerT

Presented: Thursday, March 10th at 8:00AM Pacific Time
Speaker: Michael O'Connell, Insightful Corporation

The analysis of safety data from prospective clinical trials and retrospective data such as the FDA adverse event reporting system database (AERS) has numerous challenges. Some of the key requirements include the ability to obtain:

Publication-quality reports (tables and listing) and simultaneous interactive graphical representations of adverse events and related data (e.g. labs, demographics)
Detailed statistical analysis and data mining of clinical data to identify risk factors for adverse events and related conditions
Compelling graphical analyses of adverse event and related data (e.g. labs, demographics)
Automated, repeated reports as underlying data are updated
Conditional generation and inclusion of graphical and tabular report components based on adverse event and lab data thresholds *Updates and statistical monitoring results in Sequential Design situations

In the retrospective case, signal detection from the AERS database has the challenges of its very nature e.g. lack of incidence data and lack of denominator for appropriate rate calculations. In this setting one can define internal baseline rates and use relative reporting rates for examining drugs and adverse events. In particular, Poisson and hierarchical (Bayesian) models for signal detection are helpful in comparing relative reporting rates for classes of adverse events between drugs in a therapeutic class.

This webinar describes the use of S-PLUS and Insightful Miner for safety data analysis and reporting in both the prospective and retrospective situations. S+Graphlets and the S-PLUS Clinical Reporting Pack are key components of the S-PLUS/Insightful Miner approach, for interactive and publication-quality reporting respectively. Data management and data mining in prospective and retrospective situations is nicely handled through the Insightful Miner visual workflow. The S-PLUS/Insightful Miner solution is illustrated using clinical trial and FDA AERS data.

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KDnuggets : News : 2005 : n04 : item5

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