Data Mining Data Mining Status of FDA’s Efforts Status of FDA’s Efforts
Paul J. Seligman, M.D., M.P.H. Director CDER/Office of Pharmacoepidemiology and Statistical Science (OPaSS)
Lincoln User Forum/August 22, 2005
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Background Background
• Cooperative Research and Development Agreement (CRADA) – FDA and Lincoln Technologies – Purpose: to develop data mining software (WebVDME) – March 2003 - July 2005 • Decision made to put WebVDME into production
Lincoln User Forum/August 22, 2005
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The Year In Review… The Year In Review…
• Many tasks needed to prepare for production – System Development Lifecycle (IT) obligations – User Acceptance Testing – User training – Contract negotiation, award
Lincoln User Forum/August 22, 2005
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Production Use Production Use
• WebVDME 5.1 now available for use by all safety evaluators, epidemiologists in CDER’s Division of Drug Risk Evaluation (DDRE) • Strengthens and complements existing pharmacovigilance tools – Exact details of use still being worked out
Lincoln User Forum/August 22, 2005
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Future Directions Future Directions
• Expanded application • Expanded application – medication error surveillance – medication error surveillance – assessment of safety in clinical trials – assessment of safety in clinical trials – signal detection in electronic – signal detection in electronic longitudinal medical records, claims longitudinal medical records, claims data data • Research • Research – enhanced methods (e.g., assessing the – enhanced methods (e.g., assessing the role of polypharmacy in adverse events) role of polypharmacy in adverse events)
Lincoln User Forum/August 22, 2005
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