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iSAEC and HMORN to use electronic medical records to research genetics of drug-induced SAEs

Chicago (February 02, 2011) The International Serious Adverse Events Consortium (iSAEC) announced today a new collaboration with the HMO Research Network (HMORN) to enroll subjects in research to identify genetic markers that may help predict risk associated with a range of serious drug-related adverse events (SAEs). The collaboration will diversify the iSAEC methods for developing SAE research cohorts, an essential component of the Consortium's Stage II research. Through the collaboration, the iSAEC will use the HMORN's centralized clinical data warehouses, across nine HMOs, to build research cohorts associated with the genetics of three drug-induced SAEs: hepatoxicity; serious skin rashes; and extreme weight gain in users of atypical antipsychotic medications.

The nine HMORN members participating in this collaboration are: HealthPartners Research Foundation; Kaiser Permanente Georgia; Kaiser Permanente Hawaii; Marshfield Clinic Research Foundation; Group Health Collaborative and Geisinger Center for Health Studies; Henry Ford Health Care; Kaiser Permanente Southern California; Harvard Pilgrim Health Plan; and Kaiser Permanente Colorado. Each member will use detailed clinical profiles to search for potential subjects to enroll into these SAE research projects using their electronic medical record (EMR) databases. This second phase of this on-going collaboration is expected to take twenty four months.

"Our efforts to date on drug induced immunologic SAEs have mainly leveraged traditional academic networks, recruiting research subjects across a limited number of hospitals," said Arthur L. Holden, Chairman of the iSAEC. "By working with these nine leading HMOs, all of whom have sophisticated EMRs and outstanding clinical research capabilities, we hope to open up a new, more scalable research channel to enroll subjects into this vital research. Our goal is increase the breadth and diversity of patients participating and to provide our clinical research collaborators with larger, more developed research cohorts in a more efficient and effective manner."

The collaborators plan to compare the genetic and clinical data from EMR derived "cases" to healthy control groups, with the goal of identifying genetic mutations that are associated with the specific SAE. To date, the iSAEC has already made significant genetic discoveries in support of its mission to better understand the role of genetics in drug-induced SAEs. The HMORN-iSAEC collaboration will facilitate the discovery and validation of these and additional genetic findings.

"Many adverse drug reactions are probably a result of genetic differences among patients," said Robert Davis, MD, director of the Kaiser Permanente Center for Health Research-Southeast and a member of the HMO Research Network. "Through our research with the iSAEC, we hope to identify these differences and screen patients before they are treated, thereby reducing morbidity and mortality associated with drug therapies. Because of our large population, ethnic diversity, and the wide range of medications prescribed, the HMORN is an ideal partner for this collaboration."


Contact: Arthur Holden
Edelman Public Relations

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