Study of Genetic Basis for Adverse Drug Reactions

The new study will help explain how differences in an individual's genetic profile affect his or her susceptibility to a serious adverse reaction across a broad class of medicines, and may lead to tools and procedures that enable more effective prescribing of these medicines, including diagnostic tests that could identify patients who may be at risk. By identifying and studying the associations between specific genetic traits and individual response to drugs, known as pharmacogenetics, GSK intends to identify predictive genetic markers that could increase drug safety as well as provide scientific understanding of ADRs at the molecular level.

FGT is managing the study using its web-enabled enTRUST Genetic Banking System. This system is serving as the information technology infrastructure for collecting, storing, and managing patient enrollment, informed consent, and clinical data in a highly secure, validated system that protects patient confidentiality and data security. The system is also being used to securely recontact patients online for additional consent for new research or phenotypic information. First Genetic Trust will be using innovative recruitment approaches that test the feasibility of studying serious adverse events.

"Through the use of its enTRUST banking system and its specialized expertise in pharmacogenetic clinical trials, First Genetic Trust has proven to be a reliable partner in effectively managing pharmacogenetic studies and the resulting sample and clinical information,” says Daniel Burns, senior vice-president, genetics research at GlaxoSmithKline.