An electronic patient-reported outcome system has played a key role in a Phase II trial. The trial yielded positive results for a hepatitis C treatment from Biolex Therapeutics.
During the trial, subjects reported flu-like adverse events on a daily basis through the ePRO system. In addition to the ePRO data, researchers recorded adverse events using traditional weekly assessments at the trial sites. A comparison of the data from both reporting methods confirmed the ePRO results, the company says.
Biolex worked with solutions provider Unithink to develop the system, according to a company spokesman in an email. The Biolex clinical team worked internally to customize the ePRO infrastructure to the data collection and analysis needs. It was a "fairly straightforward implementation," the spokesman says. And the reporting method yielded insight to subjects' experiences with the side effects and the impact on their daily activities.
The drug being tested, a 480-microgram dose of Locteron, yielded a statistically significant reduction in the frequency and severity of the flu-like adverse events among subjects compared with the PEG-Intron control treatment. The trial demonstrated strong anti-viral response of the experimental treatment, according to Biolex.
- see the Biolex release