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iSAEC Using HMO Research Network's EMRs to Recruit Patients for PGx Studies

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The International Serious Adverse Events Consortium is enlisting the help of HMOs and research institutes with electronic medical records to identify genetic markers linked to drug-related adverse events.

The iSAEC announced this week that it will work with nine members of the HMO Research Network, which includes HealthPartners Research Foundation; Kaiser Permanente in Georgia, Hawaii, California, and Colorado; Marshfield Clinic Research Foundation; Group Health Collaborative and Geisinger Center for Health Studies; Henry Ford Health Care; and Harvard Pilgrim Health Plan.

"Each member will use detailed clinical profiles to search for potential subjects to enroll into … serious adverse events research projects using their electronic medical record databases," iSAEC said in a statement.

The iSAEC was founded in 2007 as partnership between research institutes, regulatory authorities, and the pharmaceutical industry to discover the genetic underpinnings of adverse drug reactions.

The consortium last year announced separate collaborations with two UK academic research institutions to expand recruiting capabilities for studies on the pharmacogenetics of drug-induced hypersensitivity reactions and liver injury. iSAEC is working with the University of Liverpool's Wolfson Center for Personalized Medicine on the hypersensitivity research project, and the consortium is collaborating with investigators at Newcastle University's Institute of Cellular Medicine to study liver injury (PGx Reporter 09/15/10).

According to the consortium, the collaboration with the HMO Research Network is critical for enabling the next phase of its ongoing research efforts to speed the discovery of genes that impact three adverse events associated with anti-psychotic drugs: serious skin rashes, hepatoxicity, and serious weight gain.

It will take two years for all the collaboration members to mine their electronic records for genetic data and pick out potential study subjects. Then, the collaborators hope to compare genetic and clinical data from these study participants to healthy controls.

ISAEC said that its research studies will have IRB approvals from all participating centers, full informed consent of the patients, and all data gleaned from EMRs will be made anonymous.

Separately, the iSAEC also announced the publication of the first genome-wide association study looking at the genetics underlying drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in the January issue of the Pharmacogenomics Journal.

"Although no genome-wide significant associations with SNPs or copy number variants were observed in this initial study, there were several genomic regions identified that could play a role in predisposing patients to drug-induced SJS/TEN," the iSAEC wrote in a statement. The iSAEC believes that this research is a first step, and the findings need to be further investigated in larger and more ethnically diverse cohorts.

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