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