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SAEC Teams with HMOs on PGx Study

NEW YORK (GenomeWeb News) – The International Serious Adverse Events Consortium (SAEC) plans to collaborate with the HMO Research Network (HMORN), a consortium of 16 health plans with 14 million members, to determine the feasibility of using HMORN's clinical data warehouse to study drug-induced serious adverse events.

The SAEC is a private partnership of major pharmaceutical companies, the US Food and Drug Administration, and academic institutes that is focused on finding and confirming genetic markers that could be used to develop pharmacogenomic tests for drug-related serious adverse events.

HMORN represents several hundred doctoral-level investigators, clinical researchers, and research personnel, and its data warehouse includes inpatient admissions, and emergency room and outpatient visits.

Initially, the collaboration will focus on drug-induced SAEs, such as hepatoxictiy, serious skin rashes, and extreme weight gain, linked to some antipsychotic medications. The collaborators hope to identify genetic mutations associated with these drug-related adverse events and to provide a foundation for later studies that will validate those genetic variations.

This early phase of the studies will last around 12 months and will involve Geisinger Center for Health Research, Group Health Research Institute, HealthPartners Research Foundation, Kaiser Permanente Center for Health Research-Southeast, Kaiser Permanente Center for Health Research-Hawaii, and Marshfield Clinic Research Foundation

Each of these HMORN members will use detailed clinical profiles and electronic medical records to search for subjects for SAE research projects.

"Our efforts to date on drug-induced liver injury and serious skin rashes have leveraged traditional academic networks recruiting research subjects across a limited number of hospitals," explained Arthur Holden, chairman of the SAEC, in a statement. "By working with these leading HMOs, all of which have sophisticated electronic medical records and outstanding clinical research capabilities, we hope to open up a new, more scalable research channel to enroll subjects into this vital research."

The SAEC has based its IT infrastructure at a data analysis and coordinating center at Columbia University. The consortium will provide the research community with "free and unencumbered access to study data," and results from the association studies will be available for future study and validation, SAEC said.