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December 15, 2004 05:21 PM US Eastern Timezone GSK, Vanderbilt, and FDA to Collaborate in Evaluating Innovative Approach to Studying Unanticipated Serious Drug Adverse Drug Events Using First Genetic Trust's enTRUST System First Genetic Trust (FGT) today announced that the FDA, Vanderbilt University Medical Center, and GlaxoSmithKline (GSK), will take part in an innovative post-marketing clinical research effort using FGT's enTRUST genetic banking and research technology to study the genetic basis for drug-induced Long QT, a well-known side effects for many different classes of drugs. Patients who exhibit Long QT are at risk of developing problematic heart arrhythmias that may in rare cases, lead to sudden death. Using FGT's system, GSK is recruiting Long QT patients electronically through Vanderbilt and a network of referral sites, and using their collected blood samples and clinical data to study the genetics of the side effect across several classes of drugs. The FDA has agreed to facilitate enrollment in the study by sending letters to health professionals who have reported a case of Prolonged QT or Torsades de Pointe (a particularly severe form of the adverse event) through MedWatch, informing them of the study and giving them the information to voluntarily inform their patients about the study. FGT's web-based technology enables patients to enroll in the GSK-VANDERBILT study and give their informed consent online through a single enrolling site at Vanderbilt or be referred there electronically through an extensive network of additional clinical sites. The method and process being tested allows pharmacogenetic studies of Long QT and possibly other unanticipated serious adverse side effects to be studied more rapidly and cost-effectively than traditional approaches using many separate recruiting sites. This offers the hope that predictors of such side effects can eventually be identified, thus making medicines safer. The FGT technology also enables patients who give explicit consent to be recontacted electronically for further data collection or to be re-consented for additional studies, an important element in post-marketing safety surveillance. This collaborative study serves as an important model for studying unanticipated adverse events of drugs after they are approved for the marketplace and is designed to compliment to existing post-marketing surveillance programs. A number of referring physicians have already begun telling their patients about the study. "The response to this approach has already been very encouraging," said Dan Roden, M.D. of Vanderbilt, Principal Investigator on the study, "and the support of FDA will be extremely helpful in making it successful." The study is also being conducted with the same approach in Canada. Dr. Paul Dorian of the St. Michael's Hospital of Toronto will be the enrolling site for Canadian patients. Patients who have experienced heart rhythm abnormalities as a result of taking medications and who wish to participate in the study may contact info@firstgenetic.net for the appropriate referrals. About First Genetic Trust Founded by leaders in the fields of genetics, bioinformatics, and information systems technology, First Genetic Trust provides genetic data handling and bioinformatics services to pharmaceutical companies, medical researchers, and health care providers engaged in genetic research. The company has developed its enTRUST(R) Genetic Banking platform to provide coordinated management of sample, phenotype, and genetic data with capabilities for sample tracking and reuse, data acquisition and management, data security, and management of informed consent in support of pharmaceutical research, clinical development and post-marketing studies, as well as genetic research programs in the health care provider and government sectors. First Genetic Trust (www.firstgenetic.net) is headquartered in Chicago and has its research and development facilities in Rutherford, New Jersey. The contents of the Long-QT-Syndrome.com Site, such as text, graphics, images and all other material contained on Long-QT-Syndrome.com are for informational purposes only. The contents were not written by a practicing medical doctor/physician and may not be correct. The content within Long-QT-Syndrome.com is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on the Long-QT-Syndrome.com Site! |
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