Database Design for Clinical Trial Xiaoqing He & Gilsinia Lopez [1,2]

Goals Build an essential online resource for tracking side effects of $1 trillion worth of prescription meds sold around the world Applications for both healthcare professionals and patients Increase transparency throughout the healthcare and pharmaceutical industries

Current status 75 % data capture – paper based Data inconsistencies Data Entry error Only 10 percent of data are reported Solution Electronic data capture – eCRF

Problems with eCRF Incomplete Filled with misspelling Misclassification Out of date

Adverse Events Inc. (RxFilter ™) RxFilter – 17 step data normalization process Normalizes the FDA’s adverse events reports into a single report, and standardizes the data for improved accuracy of adverse drug event information

Achievements and Claims of Adverse Events Inc. Lamictal and Keppra, which are classified as may be “as dangerous to a fetus as drugs currently listed” should be placed in a more risky category measure medication side effects and ensure high quality standards to protect patient safety supports companies with competitive intelligence and data to inform drug marketing decisions and business development strategies.

Relationship With Course Relevant to chapters of Conceptual modeling and Relational Database Design Data collecting, Standardizes and Normalizes the data Basic of Functional Dependencies and Normalization

Reference [1]Luke Timmerman, Biotech, Startups, IT, Sep. 2011, seeks-to-keep-track-of-drug-side-effects-the-way-the-fda-never-could/ [2]Business Wire, Sep. 2011, vents-Launches-Innovative-Comparative-Drug-Side-Effect [3]Picture 3-6 is from PITOR [4]Picture 1 is from [5]Picture 2 is from