Business at PHT is brisk. The private company doesn’t release financial data, but did issue a press release about its recent quarter. Its solution was selected by 10 biopharmaceutical companies for use in a record 26 new studies worldwide.

The company, as one might expect, does its best to track the use of handheld diaries vs. paper patient diaries. PHT estimates (as do many observers of the industry) that thirty percent of studies use a patient-reported element of some kind. Within that slice, 6 percent of trials used electronic diaries in 2003, 9 percent in 2004, 12 percent in 2005. PHT expects 2006 will end with the level of adoption at approximately 14 percent and estimates the number will be 16 percent in 2007.

ClinPage recently chatted with Phil Lee, PHT’s president and CEO. Lee says PHT’s head count is up to 130, not counting 20 contractors, with employees being brought aboard for training in anticipation of contracts as yet unsigned.

ClinPage: Do you see any signs the electronic patient-reported outcome (ePRO) sector of the industry is slowing down?
Lee: Right now, I would say we don’t see any end in sight. The adoption is coming along very, very nicely. For two to four years out we don’t see any slowdown. Which is very exciting for us and for the industry.

How are customers feeling about handheld patient diaries?
Lee: They’re not coming forward with one or two studies. They show up with five studies over a 2-year period. They are concerned if we are able to scale and have developed efficiencies. They are concerned with overwhelming us.

What’s the most important message from FDA attempts to disseminate the agency’s thinking on e-diaries and patient-reported outcome data? There seems to be this idea of ‘temporal enforcement,’ or making sure a diary entry is completed when it’s supposed to be.
Lee: There is no way to do that except with an electronic diary. The sponsor needs to do something. How would they ensure the patient is filling it out on the morning of November 21? They can’t. That’s a strong encouragement for them to use the electronic diary.

In thinking about competition, is the business landscape any easier with so much work for all of the electronic diary providers?
Lee: It’s pretty competitive. In general, there are 2 if not 3 vendors bidding every single opportunity. We’re at the point where generally [most sponsors] have selected a preferred provider. We’re starting to see more of them just come back and work with us without going through the full evaluation cycle.

Any thoughts on the merger of ClinPhone and DataLabs? Does that change your competitive dynamics?
Lee: We actually don’t see that as competition. I see that as a really good thing and hope they do well. I view that [deal] as helping the ePRO industry. If [sponsors] are using EDC and paper diaries, that is not going to be very helpful. They can’t lock the database until the data from the paper diaries are entered. The more they use EDC, the more it will drive them to use ePRO concurrently.

Any other trends?
Lee: The biggest trend we are seeing is the desire to collect information on medical devices and wirelessly transmit it to the PDA. We’re seeing a lot of traction with the respiratory side of that. We’re getting some interest on the cell phone. It is mobile. You can take it wherever you want.

It could be attractive to use a device that many patients already own and understand …
Lee: It is clearly a possibility and I see that changing over time. But the screen is very small. That creates challenges. The other problem with the cell phone is that the technology platform it’s built on is not as sophisticated as Palm.

Thanks, Phil.

Earlier this fall, the company won an award. In the category of B2B Applications Provider, PHT took home the 2006 Technology Leadership Award from the Massachusetts Technology Leadership Council (TLC). The TLC is “committed to fostering entrepreneurship and promoting the success of companies that develop and deploy technology across industry sectors. These awards are an important part of this effort,” said Joyce L. Plotkin, president of the organization’s leadership council.

Next week: ClinPage will report on a PHT webcast that reviews some of the nuances of validating or re-validating paper instruments for collecting patient experiences. We’ll also have an interview with another diary provider, CRF.