The module, which works alongside the company’s ICOPhone interactive voice/web response (IVR/IWR) services, should remove on the of the barriers for the adoption of electronic patient diaries rather than a paper-based system, according to Kris Gustafson, senior vice president of ICON’s Intercative Technologies group.
“Typically, ePRO is a custom solution that is built for the client, a process which can take up 12 weeks to implement,” said Gustafson in an interview. “Our ePRO module is a pre-configured system that removes the need for a 4-5 week programming and testing phase.”
Shaving that amount of time off the set-up is crucial, he added, because a 12-week implementation can be a disincentive for trial sponsors to use an electronic rather than a traditional paper-based system. Now there is no need for the electronic patient diary system to be a rate-limiting step in the process.
ePRO has many demonstrated advantages over paper. It allows a much greater level of control over the type of data inputted by patients, as well as logging the time it is entered.
There have been cases where patients have entered several days or weeks of data in one go, for example. Using ePRO provides an additional check that can improve the integrity and quality of the patient diary, and when coupled with a phone or web-based system can even be used to prompt patients to fill in the entry at the appropriate time.
That quality claim has been backed up in studies, including one carried out by the National Cancer Institute in the US, which found that actual compliance with patient diaries was 94 per cent for the electronic version and just 11 per cent for paper*.
A paper-based system can also be more resource-intensive, requiring many people to collect, check and process the diary entries, according to Gustafson.
Use of ePRO is still in its infancy, with just 15 per cent of studies using it in 2007, up from around 5 per cent in 2002, he said. But adoption is accelerating, and a quarter of all trials or more are expected to use some form of electronic patient diary within two to three years.
The ICOPhone ePRO module “offers real-time access to more accurate and reliable data, faster validation of that data and reduces the typical implementation time for IVR/IWR systems,” he said. That should enable “studies to reach critical milestones faster and regulatory submissions to be submitted sooner.”
Gustafson believes that the combination of the configurable ePRO module and IVR/IWR system is an offering that “unique” in the marketplace at present.
Other companies providing IVR/IWR and ePRO systems include ClinPhone, eTrials and Perceptive Informatics, and there seems to be an emerging trend towards bundling eClinical components together into single products to avoid problems such as data reconciliation and cleaning. For instance, ClinPhone recently launched a system that combined electronic data capture (EDC) with IVR/IWR.
Handheld deal adds third pillar to ICON portfolio
ICON has also invested in the hardware end of its ePRO business via a partnership with PHT Corp in the area of handheld devices.
The two companies agreed in June that ICON will be able to provide PHT’s LogPad handheld electronic patient diary, and the SitePad device for capturing data, to clients for use in clinical trials. That handheld option adds to ICON’s existing expertise in phone and web-based systems, said Gustafson.
“Handheld devices are great for recording anything on a visual scale,” he said. “For example, a patient can use them to note both the intensity of pain on a visual scale, as well as the location in the body.”
Handhelds are also of particular benefit when real-time capturing of data is critical, according to Gustafson.
* British Medical Journal 2002;324:1193-1194