DSG’s Successes with Human Genome Sciences

In covering clinical trials, we are seeing more focus on the activities in specific therapeutic areas. Not that they didn’t exist before, but the frequency with which companies are identifying the specific conditions for which they have experience are on an uptick. These experiences can parlay into other contracts in similar conditions, or add to the company’s cadre of experience, as well as the overall impression, the company already exhibits.

This is where DSG has found itself, three years after beginning work with Human Genome Sciences (HGS) on its quest to develop the first new drug to address systemic lupus in over 50 years.
HGS announced in July it had met the primary endpoint in its BLISS-52, the first of two pivotal Phase III trials for patients with serologically active systemic lupus erythematosus (SLE). This was HGS’ first experience with EDC. The complexities of the data collection for the drug BENLYSTA included, with more detailed information available from this HGS press release:

* hundreds of sites around the world, including Australia, all of Asia, Eastern and Western Europe and the Americas.
* ability to run on a 24/7 schedule
* four concurrent studies, comprising a few hundred trials
* One study included 865 patients, the sister studies over 1,000 patients
* 400-600 eCRFs per patient
* 1,300 edits per screen (typical disease averages 100 edits)

In addition, according to Tony Varano, CEO of DSG, HGS had external IVR and CTM systems that needed integrating into the EDC.

Varano explained the numerous edit checks required by HGS were helped along by using DSG’s own library of validation and edits. What was new to the HGS project was the need for a data management portal. “With this study, with the disease and the complexity, we found that they needed information presented to them in a way it’s never been presented before,” said Varano. “It had huge paybacks for efficiencies.”

So much so the centralized and interactive Clinical Data Quality Control (CDQC) checklist, was nominated into SCDM’s 2008 Data Driven Innovation Award, winning second place for the ability to assess the status of cleanliness for a given project. The award is structured so that a sponsor has to nominate the product and the product must have been used in a live situation.

The successes continued with DSG then incorporating the portal into its eCaseLink EDC software application. DSG also offers the full suite of eClinical modules, including ePRO, CTMS, data management, IWRS, and more.

The DGS team received major kudos from HGS, noted in this release, including DGS’ leadership, problem solving, innovative solutions, site and CRA happiness, clean data, and more. For Varano, he said, “To address lupus, after a graveyard of failures of drugs for this disease, and bringing the first drug along in 50 years, it’s very exciting for HGS and the industry. And helping the lupus community, it’s a big deal from that perspective.”

“In some respects, we’re just a vendor,” continued Varano. “But clearly, HGS sees that we handled their high-profile global study.”

The company, a privately-held entity for over 17 years, reported record growth for the first half of 2009. Varano shared that the company handles over 10 new studies a month.