P

erceptive Informatics, the eClinical subsidiary of US-based contract research organisation (CRO) Parexel International, has signed a licence agreement with the EuroQoL Group giving it access to EQ-5D, the Group’s standardised instrument for measuring health-related quality of life (QoL) outcomes.

Under the agreement, Perceptive Informatics can supply EQ-5D through its Electronic Patient Reported Outcomes (ePRO) solution in an Interactive Voice Response (IVR) format. This will enable clinical trial sponsors to collect, via telephone, health-related QoL outcomes reported by patients.

The instrument provides a descriptive profile and a single index value for a particular health status. There are 83 official-language versions of EQ-5D and the instrument is non-disease specific, making it applicable to a wide range of geographies, health conditions and treatments, Perceptive noted.

“The use of electronic patient-reported outcomes in clinical trials has grown rapidly, especially as ePRO data … has expanded beyond efficacy data to include safety, inclusion/exclusion, and medication compliance data,” commented Steve Kent, President of Perceptive Informatics. “As sponsors are now using ePRO for major therapeutic areas across phases of trials, our goal is to offer more value to clients in this important component of an overall eClinical platform.”

Perceptive’s ePRO solution in an IVR format offers an “intuitive interface” for capturing patient reported data, ranging from diaries and validated instruments to complex clinical assessments, the company explained. Patients can use the Perceptive ePRO system by dialling a toll-free number and accessing an application delivered in their own
language.

The applications are designed to facilitate rapid progression through questions, while responses can be logged using a telephone key pad. At the same time, study sponsors and investigator sites can access ePRO data and diary compliance metrics in real time via an online web reporting capability.

The Netherlands-based EuroQoL Group was set up in 1987, to explore the feasibility of developing jointly a standardised, non-disease specific instrument for describing and valuing health-related quality of life. The Group is a network of international, multilingual, multidisciplinary researchers, originally from seven centres in England, Finland, the Netherlands, Norway and Sweden.