MED Watch Dashboard - Big Data Mining on Safety Information and Adverse Event Reports
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MED Watch Dashboard Big Data Mining on Safety Information and Adverse Event Reports http://medwatch.co.nf Budapest Users of R Network, 2014.01.15
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MED Watch Dashboard - Big Data Mining on Safety Information and Adverse Event Reports
- 2. 2014.01.15 Budapest Users of R Network 2
- 3. Data Source (FDA) • • 2012 Q4 Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Special Nutritionals, and Cosmetics) The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient. 2014.01.15 Budapest Users of R Network 3
- 4. MED Watch Dashboard Viewers http://medwatch.co.nf December of 2013 2014.01.15 Budapest Users of R Network 4
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- 6. Data Clean - 1 • • The raw reported data have been cleaned according to the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The verbatim reactions/indications have been coded into the system organ class (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA version 13.1) for coding of diseases/medical conditions. 2014.01.15 Budapest Users of R Network 6
- 7. Data Clean - 2 ● The raw reported datasets have been transferred into CDISC SDTM datasets, and also into CDISC ADaM datasets which are the basis for production of statistical graphs in R statistical package including: – Shiny, – vcd (The conditional density plot - Hofmann and Theus 2005), – Basic Hexagon Binning Functions (hexbin) – rworldmap(joinCountryData2Map, mapCountryData), – ggplot2. 2014.01.15 Budapest Users of R Network 7
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- 14. LIE Factor - Edward Tufte Define the maximum ideas to the audience: • In the shortest time, • Minimize the number of "ink", with the smallest optimal representation. • Tell the truth about the data. 2014.01.15 Budapest Users of R Network 14