By Deborah Borfitz
Sept. 3, 2008 | Accurate and timely data collection has always been critical to subject safety in first-in-human clinical trials. It is even more so now that a growing proportion of the Phase I study population are patients with serious medical conditions rather than healthy volunteers.
With that in mind, Duke University Medical Center made a decision earlier this summer to license the electronic data capture software of London-based Logos Technologies. The Alphadas system is especially well designed for the complexities of early phase trials, says Barry Mangum, PharmD, FCP, director of clinical pharmacology for Duke Clinical Research Unit (DCRU) and associate professor of clinical pharmacology at the medical center. “We can understand the safety profile [of compounds] earlier than we ever could have before.”
Alphadas was chosen over competing products because it is Web-based and was the “easiest to use,” says Mangum. The system’s integration with Exco InTouch (see eCliniqua, June 23, 2008) didn’t occur until after Duke selected Alphadas, but is an appealing product feature that will most immediately be used for text messaging study-related reminders to enrolled patients.
Logos Technologies has already built a bidirectional interface between Alphadas and the data-collection systems of LabCorp, says Mangum, reducing the potential for human error as blood samples move from collection to analysis. Lab results also get “seamlessly integrated into source documentation.”
“Alphadas has been installed at Eli Lilly and some CROs [clinical research organizations], but we are the first academic medical center to embrace the product and form strategic relationships to improve what we do,” says Mangum. “Our goal is to improve the drug development process in early phase clinical trials. By using the Alphadas product, we think we can provide a safer central core directed source record.”
For years now, Duke has been trying to “bring a heightened awareness to clinical research, including Phase I trials,” says Mangum. About 800 of Duke’s faculty are engaged in clinical research funded by both the National Institutes of Health (NIH) and industry. In 2006, DCRU became the first recipient of an NIH Clinical and Translational Science Award. The five-year, $53 million grant is intended to help researchers more quickly develop and deliver treatments to patients. By 2010, the awards will replace traditional General Clinical Research Unit grants bestowed on academic institutions.
“Our institution does a fair amount of industry and academic [investigator-initiated] proof-of-concept drug development work,” says Mangum, including pediatric ophthalmology studies. It is now making a committed effort to do more early-phase clinical research on compounds involving pediatric and adult diseases.
Phase I trial capacity at Duke is limited only by infrastructure. DCRU consists of a 30-bed adult, multi-therapeutic confinement unit and a six-bed pediatric confinement unit with an additional 13 beds available for overnight stays by parents and guardians. It is one of the few, if not the only, academic medical center conducting both adult and pediatric proof-of-concept trials, says Mangum.
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