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Database Design for Clinical Trial

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

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Database Design for Clinical Trial

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

  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

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

  4. Problems with eCRF • Incomplete • Filled with misspelling • Misclassification • Out of date

  5. 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

  6. 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.

  7. 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

  8. Reference [1]Luke Timmerman,Biotech, Startups, IT, Sep. 2011, http://www.xconomy.com/san-francisco/2011/09/27/adverseevents-com-seeks-to-keep-track-of-drug-side-effects-the-way-the-fda-never-could/ [2]Business Wire, Sep. 2011, http://www.businesswire.com/news/home/20110926005053/en/AdverseEvents-Launches-Innovative-Comparative-Drug-Side-Effect [3]Picture 3-6is fromhttp://adverseevents.com/drugdetail.php?AEDrugID=807&BrandName=LIPITOR [4]Picture 1 is from http://www.drofdetox.com/overview-of-clinical-trial/ [5]Picture 2 is from http://www.ecrf.biz.pl/about_en.htm

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