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ClinPhone: ePRO Over Plain Old Telephones

The human eye is drawn to glitter, to flash. A Windows-based Treo, a snazzy Powerbook, a flat-screen TV as big as Nebraska. It can be irresistible. Then the next new gadget arrives and the old one is moved to the basement.

So an interactive voice response (IVR) outfit like ClinPhone is in a bind. They have no Bluetooth-enabled, photo-snapping, MP3-playing Crackberry to offer. None. Just stuff that works every time, like a patient's touch-tone telephone.

For now, ClinPhone is bigger than most of the companies using hand-held Palm patient diaries. Its IVR solution for electronic patient-reported outcome (ePRO) work is not so well known. But ClinPhone recently put out a press release noting it had completed 215 ePRO studies. To be fair, that figure includes 115 trials completed by ClinPhone itself, and 100 trials done by a Madison, Wisconsin partner, Healthcare Technology Systems (HTS).

We caught up with Keith Wenzel, an ex-HTS person now working for ClinPhone as product director of ePRO. Wenzel took pains to say that ClinPhone does more than just psychiatry ePRO studies, the forte of HTS.

Tools to measure quality of life, he says, have been licensed from HTS and other third-party authors and validated across several therapeutic areas: diabetes, smoking cessation, oncology, and respiratory disease, for starters.

"With our relationship with HTS, we have a unique advantage over all the competition in central nervous system disorders," Wenzel says. "But I don't believe it's therapeutic area-specific. We're seeing a majority of our growth be other self-report assessment, or other assessments that used to be done by a clinician and are moving to self-report."

An ongoing mystery in the ePRO field is which data-collection modality (IVR or PDA) is suited for a particular trial. Naturally, the patients and the protocol must be considered. Wenzel doesn't have dogmatic views about choosing IVR vs. handheld, or at least didn't espouse one to us.

But the availability of broadband and general societal levels of comfort with handhelds are variables in the equation, he says. "Our discussion five years from now is going to be different," Wenzel predicts, as smartphones blur the line between audio-centric devices and screen-based devices. "IVR and handhelds are going to merge. You might see both media in the same trial. The regulatory authorities will get their head around that. You'll have the ability to record voice inflections and see things graphically."

Wenzel said the cost per subject for an IVR-enabled solution might range from $300 to $1000. With handheld diaries costing $1,000 to $1,500 per patient, there is less of a price gap between IVR and handheld diaries than one might expect. He concedes that handheld devices do allow a patient to point at a diagram of the human body to pinpoint the source of pain.

But IVR systems are much simpler to set up. With an IVR system, you'll never need to clear customs with hundreds of modems, cradles, power cords, and other wiring. And the phone can record a patient's voice, perhaps serving as a potent reminder to a patient of how he was feeling or thriving in the recent past.

Focusing just on the per-patient cost, Wenzel says, is probably an oversight. "If you look at the cost of the device itself, you're missing part of the picture. The industry is spending all this money on data entry and data cleaning. Those costs go away."

Whatever technology is used, Wenzel says, validating the instrument in a particular trial is a crucial and sometimes overlooked step. ePRO validation is a big topic, but can involve peer-reviewed, side-by-side appraisal of clinician-based and patient-based assessments of patients. Common questions may include: is the IVR or handheld device measuring what you are intending to measure? Are they being used in a manner that conforms to previous uses in the scientific literature? Are the results comparable to what clinicians might observe? In some trials, where there is little prior published work, a validation of the ePRO  instrument may require 30 to 50 patients and take months. Is that required by the FDA? No, says Wenzel. "There is no guidance," he says. "It's a gray area."

In other cases, a less-exhaustive "cognitive debriefing" may be warranted. That might encompass tests of the ePRO instrument with real patients before a trial begins. Says Wenzel: "A cognitive debriefing is a prudent step if there is no data supporting the previous electronic use of the scale."

In choosing a technology for ePRO, Wenzel says, there are a host of variables, including the demographic composition of the patients and related caregivers. In one recent trial, parents recording data about children with attention-deficit-disorder were tested on both handhelds and IVR. The sponsor chose a phone after considering the whole disorder and the day-to-day pressures on the trial participants.

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