OpenClinica, a provider of open source clinical trials software for web-based electronic data capture (EDC) and clinical data management (CDM), has announced it has joined with the SAFE-T Consortium to conduct clinical trials in Europe and Israel to help the pharmaceutical industry find new biomarkers for the early detection of drug toxicity in kidney, liver and vascular disease for quicker and safer evaluations of potential new medications in these patients, according to sfgate.com, part of the San Francisco Chronicle blog.
The SAFE-T consortium is a public-private partnership that brings together pharmaceutical companies, universities, hospitals and biotechnology facilities to share and validate each other's safety testing methods under the advice of the European Medicines Agency and its US counterpart, the Food and Drug Administration. The consortium includes such companies as Pfizer, Novartis, Lilly, and Amgen.
The Consortium also has as its members academics and small and medium enterprises working to qualify translational safety biomarkers (a biomarker that shows a toxological effect of a drug either in a test tube in a lab or in the human body, according to the New England Drug Metabolism Discussion Group.
Biomarkers are what are studied to ascertain the damage to organs from drugs patients are taking, as reported in a study by the New England Drug Metabolism Discussion Group.
Drug-induced injury is common in liver disease patients, and accounts for 20 to 40% of liver failure and approximately 75% of these drug reactions result in liver transplantation or death, according to medscape.com.
Over the next three years, SAFE-T will conduct clinical trials in several sites around the world, the consortium's largest undertaking to date, and the project is designed to streamline the collecting and managing of essential data about drug-induced injuries, said Nicole Schneiderhan-Marra, project manager of the NMI Natural and Medical Sciences Institute in an interview as reported at sfgate.com. "By using a common EDC system from OpenClinica, we will reduce efforts in mapping collective data into a common data format.,” she said, adding that if each company were to do its own tests individually, no other companies could benefit. But by pooling knowledge, all should succeed.
The consortium will use OpenClinica's Enterprise solution, which is the commercially supported version of OpenClinica open source technology, according to the blog.
OpenClinica is able to provide efficiencies by standardizing on a common technology built on open standards (a technology that is open to use by anyone), said Ben Baumann, OpenClinica's director of business development, at sfgate.com.
Baumann added that this is beneficial to the consortium because members will only have to master one system, building report forms only once and then re-using them as necessary, eliminating redundancy, while accelerating study, start-up, and ensuring higher quality trials, according to sfgate.com.
Deborah DiSesa Hirsch is an award-winning health and technology writer who has worked for newspapers, magazines and IBM in her 20-year career. To read more of her articles, please visit her columnist page.Edited by
Rich Steeves
