CONVERSATION | PalmOne's director of healthcare sales explains why clinical trials are driving sales of handheld devices.
Interview by Mark D. Uehling
Senior Science Editor
April 16, 2004 | With a damning literature about patients not recording their experiences accurately with paper diaries, the sponsors of clinical trials are turning to handheld electronic devices. In 2003, for the first time, the FDA approved a drug — an eye medicine from Allergan — with clinical data recorded by patients using PDAs. Today, most devices used in clinical research are made by palmOne. These are single-purpose handhelds programmed with software from a handful of specialized vendors. Bio·IT World's Mark Uehling spoke to palmOne's Jason Barton, healthcare sales director, about the future of these devices in industrial research.
Q: Are e-diaries for clinical trials an important niche for a consumer-oriented company such as palmOne?
A: You're getting sponsor companies investing in e-diaries and teaming up with a solution provider like PHT, invivodata, or CRF. Usually the deals we're working on in clinical trials are in the hundreds or thousands of devices. (Editor's note: etrials, Numoda, Symfo, and other companies also provide handheld solutions.)
What are the pricing trends this year?
I see the cost of the device under $150. That is a big change. It was only a year or 18 months ago that you were looking at $350 to $400. It's significant. We have devices launching in the spring that will lend themselves very well to the clinical trials arena, which will bring the average cost way below the $200 mark.
But e-diaries for clinical trials still may cost $1,500 apiece by the time they're programmed. Given the frugality of drug companies, what is driving the adoption?
As more trials gain FDA approval having used this method, then the adoption is going to aggressively take off. Many of the solutions providers are doing a tremendous job of underlining the return on investment of e-diaries versus paper. You need to look into the whole picture, not just how much does a paper diary cost or the electronic equivalent. The cleaning of the data, the ability to communicate with patients as you go along. I've seen data that the e-diaries are actually more viable and less expensive.
How is this market different?
The clinical trial world wants a basic, low-end device. They're using our handheld as a vessel for their solution. A fancy MP3 player isn't going to enhance the offering from their perspective.
How common is using the devices in other trials versus giving the PDA to the patient at the end of the trial?
It's about 50/50 right now. Reusing devices sounds like it could be a tremendous way of getting more return on that investment. But the cost of bringing hundreds or thousands of devices back in after six to 12 months of a trial, and ensuring you get each [peripheral] piece back, can outweigh the benefit of bringing the unit in. We're hoping we can get the price of the device down to where they can be written off for each trial with the return on investment realized in a single yytrial.
That also helps you sell more units ...
Absolutely.
What's changing in terms of demand?
There's been much more interest in wireless solutions. In the past, typically, we've seen a regular handheld device. The relevance of wireless Palms has become more of a priority. With GSM (Global System for Mobile Communications) being a standard in Europe, and certainly the rest of the world, being able to use a wireless device leverages the GSM network. You don't need to take that other piece, a modem.
The cellular networks in the U.S. are not as standardized as in Europe. Will that impede wireless clinical solutions?
We've been involved in very few wireless trials here. But I think that is changing. The GSM provisions are being adopted by more carriers. It's becoming more pervasive. I see wireless solutions being used in the U.S. down the line. But right now, the choice for most providers we work with would be a tethered solution.
Are the peripheral cables and base stations irritating for some patients?
You had to use a handheld device, a cradle to charge it — and a modem. It was a three-piece solution. We thought this was unsatisfactory. We wanted to make it a two-piece solution such that it was a very simple thing, so that training of patients would be very simple as well. We went to this company, iGo. They gave us a modem/charging station for about $120. This was designed specifically for this industry, which underlines palm-One's commitment to clinical trials. The patient is instructed to pop the device into the cradle. Press the button, it sends the data down. In the same instant, it's charging the device. It doesn't sound like much, but it really does simplify the solution.
Computers to record clinical trial data remain controversial, with most companies preferring paper forms. Are PDAs suspect?
I haven't met one sponsor company yet that doesn't understand this, or realize the real benefit of an e-diary over a paper solution. That's an assumed piece. Now it's a case of, 'How do we make this viable in terms of return on investment?' The biggest thing is, essentially, we need to change what we've been doing for years. That can be a lengthy and frustrating process in any industry.
What tends to clinch a sale?
The key thing is patient compliance. There have been a lot of studies on compliance; one was in the British Medical Journal. The e-diary also allows the sponsor companies, the contract research organizations, to interact with the patients during the trial as well, which they can't do with a paper diary.
What differentiates palmOne?
Certainly, with clinical trials, the key things are the ease of use, reliability, affordability. Many of the patients are elderly. The device needs to be extremely intuitive. PalmOne has always been recognized for devices you could pick up and get on with straight away. They're very simple. I guess the other one, which has always been a huge benefit for palmOne, has been battery life. We have always tried to ensure you get a week's worth of battery life — and often more on the tethered solutions. With the Tungsten T, you're getting a minimum of 10 hours on the 802.11 [Wi-Fi] network. That would cater to the typical shift of any worker in healthcare. If you get a physician with a device and you only give him four hours of use, then it's not really worthwhile.
Officially, in public statements, the FDA doesn't sound convinced that these devices are equivalent to paper. Is palm-One helping to convince the agency?
We haven't done anything directly with the FDA, as much as I'd be happy to do so. We've just been providing the solution providers any ammunition we can, assuring them that our devices have the security they need, although a lot of times, these vendors are providing their own security in their application.
PHOTO OF BARTON BY JOHNNY MILLER