Spotfire Clinical Safety Data Visibility and Analytics for Risk Management in Drug Development

Assessment of drug safety is a key aspect of drug development. However, safety data analysis has not been in focus until quite recently. Indeed, while a large amount of safety data are collected in clinical trials and post-marketing studies; basic information, such as which types of patients have adverse events, and which adverse events and lab elevations are treatment-related, is often not well-understood. 

In this talk, TIBCO Spotfire's Michael O'Connell will present some statistical and graphical analyses of safety data in an interactive visualization environment that enables detailed clinical review of sub-populations and patient-level data. Statistical models considered include trees/forests and penalized logistic regression. These models are fitted as S-PLUS® /R analyses with resulting graphical summaries being displayed seamlessly in the interactive Spotfire environment and as publication report graphics. The analysis, visualization and review can be done during clinical trials; for clinical study reports, DSMB and advisory board meetings; and in post-marketing safety assessment. This provides an ongoing coherent and transparent picture of a drug’s safety profile for all stakeholders during and beyond the development process.