Courses

Safety Data Analysis and Reporting: Signal Detection, Data-Mining and Next Generation Methodology for Drug Risk Assessment and Safety Research Webcast

presented by Alejandro Murua, University of Montreal and
Michael O'Connell, Insightful Corporation
Thursday, Sept 29, 2005 at 8:00am PT, 11:00am ET
URL: http://www.insightful.com/news_events/webcasts/2005/09safety/default.asp
Price: Free

In its efforts to continue to serve the public health and protect public safety, the pharmaceutical industry is now challenged to set up sound pharmacovigilance plans that carefully analyze and report on pre-marketing clinical study data, minimize risk and monitor post-marketing safety. These plans include the statistical analysis and reporting of adverse events in clinical studies and the proactive analysis of observational data such as FDA AERS for signal detection and risk management. In this context, the use of sophisticated statistical analysis models and data mining techniques is of increasing importance in pharmacovigilance, as these methods are able to detect signals earlier and more accurately than current methods. This presentation includes a review of statistical analysis, reporting and data mining of clinical/safety data by way of several case studies involving clinical trial and AERS data. The case studies include statistical modeling methods such as hierarchical Bayesian models, neural nets, tree ensembles and logistic regression. The data analyses and reporting examples feature the use of S-PLUS, a highly flexible statistical workbench environment that enables advanced statistical analysis and reporting including interactive patient/subject profiling and standardized reporting.

www.insightful.com/news_events/webcasts/2005/09safety/