Transcript slides - Spatial Database Group

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 Out of date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,
http://www.xconomy.com/san-francisco/2011/09/27/adverseevents-comseeks-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/AdverseE
vents-Launches-Innovative-Comparative-Drug-Side-Effect
[3]Picture 3-6 is from
http://adverseevents.com/drugdetail.php?AEDrugID=807&BrandName=LI
PITOR
[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