PHOENIX -- To hear AstraZeneca ($AZN) and PHT tell it, there's no reason to hold off ePRO use in clinical trials. Electronic patient-reported outcome devices--handheld e-diaries, integrated voice response tools, the Internet, digital pens and tablets--are now easy enough to use and manage that there are no longer excuses for excluding them.
Proponents and opponents of the technology are created by their experience in using the technology, says Robert Holman, global account manager for technology at AstraZeneca. And that's something that sponsors and investigators can influence.
Adds Dwight Cooper, VP at ePRO solutions maker PHT Corp., even the elderly like it, contrary to what some clinicians says. They just need more or different training than other groups.
The pair spoke at last week's Partnerships in Clinical Trials conference.
AstraZeneca has taken a methodical approach in adopting the technology. It began using ePRO technology on a project-by-project basis, becoming accustomed to its capabilities. Ready to move beyond the isolated-use stage, the drugmaker then advanced to the preferred-provider stage. At this stage, it becomes easier for users to share information about their use of the technology and develop some process standardization.
AZ entered into master service agreements with three suppliers. Its selection process included a preliminary screening of available products and suppliers, a written request for information, due diligence, development of a case study for product comparisons, and then preferred-provider selection.
"It's a lot of work for the suppliers," says Holman. But this method let AZ use its corporate muscle to streamline negotiations with suppliers and drive volume discount schedules.
The company found that standardization broadened the opportunities for ePRO use, making it viable for use in more trial phases than initially considered.
AZ is currently using the preferred-provider model, Holman says, "and then perhaps we'll move to a primary-provider model, which means one major supplier and several backups." He says AZ likes to standardize on one supplier and then capitalize on the relationship.