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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 - PowerPoint PPT Presentation
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Database Design for Clinical Database Design for Clinical TrialTrial
Xiaoqing He & Gilsinia Lopez
[1,2]
GoalsGoalsBuild 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 statusCurrent status75 % data capture – paper basedData inconsistenciesData Entry errorOnly 10 percent of data are reported
SolutionSolution
Electronic data capture – eCRF
Problems with eCRFProblems with eCRFIncompleteFilled with misspelling MisclassificationOut of date
Adverse Events Inc. (RxFilter Adverse Events Inc. (RxFilter ™) ™) RxFilter – 17 step data
normalization processNormalizes 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 Achievements and Claims of Adverse Events Inc. 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,
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 3-6 is from http://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