Human Genome Sciences announced that BENLYSTA™ met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). These results show that BENLYSTA™ has the potential to become the first new approved drug in decades giving hope to people living with systemic lupus.
DSG supports HGS on four global Phase 3 studies concurrently, providing data capture and supporting data management through its function rich eCaseLink™ EDC software.
“Our clinical trial data management and collection process is essential in a large and complex Phase 3 trial. DSG’s technology leadership and project management ensured that our subject data was accurate, complete and timely,” said Pierre Verroye, Executive Director of Clinical Data Management and Clinical Programming, HGS. “This was our first experience with EDC and DSG really helped lead the way. During the live study, DSG solved emerging, unprecedented challenges through innovation and by adding completely new functionality to HGS’ system. Sites and CRAs gave us a lot of positive feedback about the eCaseLink™ system.”
The study included nearly 400 electronic case report forms per subject, which were highly complex in design and had nearly 1,200 edits per screen. DSG provided critical data reporting tools based on study requirements, allowing HGS data management personnel to continually monitor and efficiently insure data quality.
HGS used DSG’s proprietary Data Management Dashboard within eCaseLink™ to rapidly identify any outstanding items needing attention during the global database lockdown. The DM Dashboard, developed with HGS to fill their unique needs won the 2008 Society for Clinical Data Management (SCDM) Data Driven Innovation Award and is now an integral part of DSG’s eCaseLink™ product.
DSG software allowed HGS to integrate a licensed Clinical Trial Management System (CTMS), and a third-party Interactive Voice Response System (IVRS) with eCaseLink™, ensuring an efficient and timely exchange of critical information.
“We are extremely pleased and excited to hear that HGS continues to make headway toward controlling SLE and has placed its faith in the technology and experience of DSG. We feel very proud not only being associated with this success but also for being a critical part of its success,” said Tony Varano, CEO, DSG, Inc. “DSG currently supports HGS with our global experience and presence on four Phase 3 studies concurrently with eCaseLink™ software. It’s very satisfying to solve such a complex problem with such a high level of technological sophistication and support service. The end result is a database lock that went very well and according to plan.”
Genetic variant identified as potential predictor for severe ulcerative colitis