The long-term objective of this project is to discover novel adverse drug events (ADEs) through use of automated methods involving natural language processing (NLP) and data mining methodologies on vast quantities of clinical data in electronic health records (EHRs) and the FDA's Spontaneous Adverse Event Reporting System (AERS). ADEs are major problems world-wide and cause hospitalizations, deaths, and incur a huge cost to health care. Therefore, continued post-marketing surveillance encompassing large and varied patient populations is crucial for patient safety. EHRs contain a comprehensive amount of clinical information, which if harnessed properly, would be invaluable for pharmacovigilance.
We have already demonstrated that we can accurately encode information in clinical reports using the NLP system MedLEE, and that we can accurately detect associations among clinical events using statistical methods that we developed. MedLEE will be used to map comprehensive clinical information in the EHR to codified data, and then statistical methods will be used to generate an extensive knowledge base of disease-symptom, disease-drug, drug-drug, and drug-symptom associations, which will be used to discover new ADEs. Additionally, we will also apply clinical knowledge and statistical methods to reduce confounding, which is a challenge when using the clinical record because there are many interdependencies in the data. We will also develop methods to map fine-grained concepts into higher level concepts, which could be important for optimizing the statistical methods. The performance of our discovery methods is evaluated by testing the methods using drugs currently in use with known ADEs, and also by using historical rollback. We are currently focusing on discovery of serious adverse events using inpatient records, and will then use the longitudinal outpatient record.
Funding
This project is supported by grants T15-LM007079, R01 LM010016, R01 LM010016-0S1,
R01 LM010016-0S2, R01 LM008635, and R01 LM06910 from the National Library of Medicine.
Publications
Email: friedman@dbmi.columbia.edu
Email: hripcsak@columbia.edu
Email: herbert.chase@dbmi.columbia.edu
Email: shagina@dbmi.columbia.edu
Email: feng.liu@dbmi.columbia.edu
Email: xiw7002@dbmi.columbia.edu
Email: rave.harpaz@dbmi.columbia.edu
Email: dowman.varn@dbmi.columbia.edu
Email: ying.li@dbmi.columbia.edu
Email: Krystl.Haerian@dbmi.columbia.edu