Abstract:
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Generating information for decision making including new drug or treatment approval based on clinical trials involves several yrs of planning, execution and organization. Most of the tools that are currently used in preparing late stage submissions have not changed (multiple sets of static tables, listings and figures (TLFs)) that are generated based on pre-defined statistical analysis plans. Although many of these TLF's are the result of several hypotheses being tested for the effectiveness and safety of a new treatment, several of these TLFs are results of many sub groups (pre-defined and post hoc). With the availability of recent tools (Spotfire, Tableau, R etc.) there are significant opportunities that have become available to explore the data and provide quick responses to customer questions including how the treatment performed in subgroups etc. Statisticians and data analysts are using these tools to respond to customer questions in a more efficient manner. However, there is a need to ramp up the usage of these tools especially in the Pharma side. This talk will provide examples of data visualizations from complex data with portability without additional burden of QC.
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