Database Design for Clinical Trial

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Database Design for Clinical Trial
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• Xiaoqing He Gilsinia Lopez

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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

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Current status

• 75 data capture paper based
• Data inconsistencies
• Data Entry error
• Only 10 percent of data are reported

Solution
Electronic data capture eCRF
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Problems with eCRF

• Incomplete
• Filled with misspelling
• Misclassification
• Out of date

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Adverse Events Inc. (RxFilter )

• RxFilter 17 step data normalization process
• Normalizes the FDAs adverse events reports into
  a single report, and standardizes the data for
  improved accuracy of adverse drug event
  information

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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.

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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

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Reference
1Luke 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/ 2Busin
ess Wire, Sep. 2011, http//www.businesswire.com/n
ews/home/20110926005053/en/AdverseEvents-Launches-
Innovative-Comparative-Drug-Side-Effect 3Picture
3-6 is from http//adverseevents.com/drugdetail.p
hp?AEDrugID807BrandNameLIPITOR 4Picture 1 is
from http//www.drofdetox.com/overview-of-clinical
-trial/ 5Picture 2 is from http//www.ecrf.biz.p
l/about_en.htm