Ditching Paper Saves Money, So What's The Industry's Holdup?

By Ed Miseta, Chief Editor, Clinical Leader

As the Global Lead for Patient Cloud at Medidata Solutions, Anne Zielinski spends some of her time looking at data. A lot of data. Her company has a database of protocols that allows her to go back over four years and look at over 1,000 protocols across a wide range of sponsors. This allows her to determine the actual percentage of trials in which patient reported outcomes are collected. That number, by the way, is 55%. She is then able to delve a little deeper to determine how the data was collected. Of the Phase 2, 3, and 4 studies that are collecting patient-reported outcomes, more than 50% are still collecting them on paper. In Phase 1 trials the rate is a little less. “The obvious question you want to ask here is, ‘Why are they still being collected on paper?’ There are some obvious issues with that, primarily around the quality of the data collected,” Zielinski says.

A May 2002 article by Arthur Stone in The British Medical Journal titled “Patient Non-Compliance With Paper Diaries” showed how unreliable paper can be. The researcher points out that not only is there an issue with patients not completing data when they say they are, but even more disturbing, many adults were prefilling in the questionnaires. Even if they were well-intentioned while doing it, in the eyes of the FDA, that is still fraud. And the FDA will not approve a drug based on fabricated information.

Anne Zielinski, Global Lead for Patient Cloud, Medidata Solutions

“There are so many quality issues involved when patients are recording information on paper,” notes Zielinski. “Were all of the required fields completed? Were they completed when they were supposed to be? Was it completed by the right person? And then there are the questions around what you do about missing data or, even more problematic, extra information scribbled in the margins. For a data manager, that unsolicited feedback is a problem, because there is really no way to deal with it. The information was reported so you feel you need to capture it, but at the same time you don’t have a field in which to enter it.”  

Problems arising from using paper can certainly impact the bottom line. Approximately 10 years ago Merck was able to show that the statistical distribution of responses they were getting to patient reported-outcomes on paper was variable, as opposed to a regular bell-shaped distribution that would be expected when using an electronic system (ePro). That statistical variability resulted in the company having to recruit more patients for the trial simply to get statistical validity.

Why Are We Still Using Paper?

With the issues presented by paper, going electronic might seem like a no-brainer. If that’s true, then why are 50% of patient-reported outcomes still being recorded on paper? Zielinski believes the answer to that is pretty straightforward: cost. Traditional ePro and IVR systems are customized solutions. “They might reuse batches of code, but each study is a custom project that has a heavy service focus and relies on the vendor to program or consolidate the code for that particular trial,” says Zielinski. “I was at a pharma company recently and was told the minimum price they pay for a traditional ePro system is between $200,000 and $300,000. If a trial is looking to collect a few questionnaires from patients, where they fill out maybe 20 pieces of paper over the course of a trial, then $200,000 just does not have a return on investment that can be justified. So when you discuss why some people still use paper, the problem is there just hasn’t been a system available that carries a price tag in accordance with the value being delivered.”

Currently the big push for Medidata is allowing customers to use a configuration tool that allows them to build forms that enable patients to enter data on a smart phone or tablet. This will reduce reliance on the vendor, which will eliminate the need to build custom programs. The devices being used are also common and commercially available. Many patients have them and are familiar with how to use them, so the problem of needing to deploy specific purpose devices to collect data also goes away. “The combination of all those things makes us think we can now make ePro a cost-effective solution for collecting patient-reported outcomes,” says Zielinski.

The Savings Will Add Up

Trying to justify the purchase of an electronic system can be difficult for many companies because there are soft costs involved that are hard for executives to put their arms around. But Zielinski notes there are direct costs to consider as well. The cost of printing and shipping all of the paper forms is one, but in the grand scheme of things that really does not add up to very much. The bigger direct dollar savings are from eliminating source document verification. “Data entered directly by the patient is source data, so you don’t need to verify it,” states Zielinski. “You can also eliminate the cost of transcribing the data that was entered on paper, by someone at the site or a data entry shop.”

Zielinski notes there are sponsors who reimburse investigator sites for the personnel overseeing patients while they complete the forms, making sure nothing is skipped. Software can now perform that function, since it will not allow the patient to proceed until the required data is completed. Best of all, there are no margins for them to scribble in, so the extraneous data problem is also eliminated. For a site collecting information on paper, the total savings can be substantial.  

There was a time when a lot of the pushback against electronic solutions tied back to concerns about the lack of FDA guidance. Zielinski notes all of those fears have also been finally put to rest. In issued guidance and oral presentations, the FDA has made it clear that it is onboard with the concept. “They realize there is a quality issue with data collected on paper,” says Zielinski. “As a result they have stepped up their efforts to better hear the voice of the patient. Patient advocacy groups are now part of the discussions as well. It’s one thing to look at the physiological measurements of disease and another to simply ask a patient how they feel. That increased emphasis on quality of life as a measure of success for a therapy or treatment is important, and will be a strong factor behind the anticipated growth in patient-reported outcomes.”

There Are Still Hurdles To Overcome

While the benefits of electronic capture of patient-reported outcomes may seem clear to many, there are still hurdles that must be overcome. Pharma by its nature is very conservative. The high amount of risk inherent in bringing a new therapy to market is often offset by risk reduction efforts in other areas. Most conservative of all are the data management and clinical operations personnel, who believe if something isn’t broke, it doesn’t need fixing. They need to be assured that something will work before they get onboard. Still, when Zielinski speaks with them individually about the prospect of electronic data capture, they find it hard to contain their enthusiasm.

Regardless of whether or not companies want to embrace new technologies, the time is coming when they suddenly may not have the option of delaying it. “We are at the point where consumers use a phone or tablet to buy and sell stocks, transfer money, shop thousands of retailers, and even record their time, miles, and vitals while running or walking,” adds Zielinski. “What does it say to a patient when a pharmaceutical company then hands them a piece of paper to fill out? The message they are sending, be it intentional or not, is the data is not that important or the company is not too concerned about providing a good experience for the patient. There are over 15,000 medical apps in the iPhone store alone. People are used to relying on the technology that they carry around with them every day for information, communication, and even medical tracking.”

Furthermore, Gartner has estimated that wearable devices will drive half of all app interactions by 2017. Eventually the industry will have to find more effective ways of not just capturing patient-reported outcomes, but making better sense of it as well. Paper in this day and age makes no sense, and the industry needs to start using technology in new and innovative ways.