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International Serious Adverse Event Consortium Data Access Site

The International Serious Adverse Event Consortium (iSAEC) is a nonprofit organization comprised of leading pharmaceutical companies, the Wellcome Trust, and academic institutions with scientific and strategic input from the U.S. Food and Drug Administration (FDA). The mission of the iSAEC is to identify and validate DNA-variants useful in predicting the risk of drug-related serious adverse events (SAEs).

Patients respond differently to medicines and all medicines can have side effects in some people. The work of the iSAEC is based on the hypothesis that these differences have a genetic basis, and the Consortium’s research studies intend to examine the impact genes can have on how individuals respond to medicines. The initial studies are focused on identifying the genetic markers associated with drug-related liver toxicity (the leading cause of acute liver failure) and Steven Johnsons Syndrome (SJS, a severe form of skin necrosis). The identification of these genetic variations is believed to be essential to develop safer drugs while also identifying patient populations for whom a medicine will have the greatest likelihood of providing medical benefits with the fewest risks.

Data

The iSAEC has collected well phenotyped SAE case data from the participating pharmaceutical companies and academic institutions/networks. In addition to clinical data, samples from the affected cases have been collected and genotyped using the high-density genotyping chips, along with properly matched controls. These well-characterized databases of DNA and clinical data have undergone extensive computational analysis to identify genetic variants that may be associated with these SAEs.

saec_distAvailable samples per adverse event

The iSAEC’s data dissemination web site has been setup to provide access to the iSAEC data by qualified researchers exclusively for the purpose of conducting biomedical research. A key goal of the iSAEC is to facilitate and accelerate scientific research on the genetic determinants of adverse events by making raw data and analysis results freely available to the public. All research results are being available within 12 months of the completion of the study group's genotyping. Further, raw data are also freely available to qualified researchers that sign the consortium's data use agreement. To request access to raw data, please complete the online registration form and follow the access procedure.