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Rethinking Pen and Paper in Clinical Trials

By Andrew Mackenzie

May 12, 2005 | Paperless? We doubt it. Less paper? Maybe.

Despite the rapid growth in computerization, and decades of talk about the demise of paper, healthcare remains largely paper-based. The majority of clinical trials are paper-based, and the Printing Brokerage/Buyers Association recently ranked the pharmaceutical sector #3 in terms of increasing print potential.

There are several reasons for the continued dominance of paper, including familiarity/ease of use and complexities in automating key processes. But automation can provide considerable benefits, including rapid availability of data, and improved efficiency of the downstream workflow. In order to bridge the gap between the attractions of paper, and the benefits of automation, HP has invested significant resources into the development of a forms automation system, based on Digital Pen and Paper (DP&P) technology. Here’s how it works.

Ordinary paper forms (including pre-existing data) are printed on demand with a nearly invisible background pattern. A pen, which includes a built in infrared camera, force sensor, and processor, is used to complete these forms. The pen, which can be used for a full workday, and can store up to 200 pages, is then placed into a docking station, which downloads the data via a USB interface to a back-end server. Depending upon the characteristics of the data, some of it is then immediately digitized (e.g., check boxes), some is analyzed using handwriting recognition, and some is retained as an image (e.g., diagrams and sketches).

Together, the digital pen, docking station, and processing software comprise a powerful forms automation system that computerizes paper-based processes. Almost two-dozen successful deployments have been conducted in diverse settings including manufacturing, direct patient care (both inpatient and outpatient), and clinical trials.
Phase One Trials Started

Perhaps the most obvious application of DP&P for clinical trials is in the capture of data for case report forms (CRFs). DP&P is currently being used by a big pharma to capture subject data in Phase I trials, as well as patient data in a series of large scale clinical research projects being conducted in more than 40 European hospitals.

The results of these and other deployments have been compelling: compared to pure paper systems, DP&P allows for known data to be “pre-entered” into forms, thus increasing accuracy and improving efficiency of workflow. DP&P also eliminates the need for subsequent key entry of data and scanning, saving both time and money (30 to 80 percent savings, depending upon the environment). In addition, data can be made available almost immediately for use by both the sponsor and the data safety monitoring board, resulting in the increased efficiency of the trial process, as well as improved patient safety.

Both DP&P and electronic data capture (EDC) technologies can enhance clinical trials processes. There are also advantages for both technologies; DP&P requires virtually no change in workflow and very little user training (the two most common complaints of EDC users). In addition, the paper itself serves as a backup and archival medium. On the other hand, EDC offers real-time error checking during data capture, while DP&P offers near real-time error checking — at the time of docking. In a recent study from CenterWatch, most EDC users continue to use paper as the initial data capture mechanism, which suggests that DP&P may have a viable role to play as an alternative, or complementary, technology to EDC.

DP&P is also well positioned to serve as a data capture tool for patient reported outcomes (PRO) and patient diaries: the hardware acquisition costs for DP&P are significantly lower than for a tablet PC, and maintenance costs for DP&P are minimal. In addition, DP&P is highly portable and much more environmentally robust than PCs, able to resist physical abuse and extremes of temperature and humidity.

Future development plans for DP&P include enhanced data validation capabilities during the data capture process, and improved integration with wireless capabilities. Will paper totally disappear? Probably not in the foreseeable future. Meanwhile, bridge technologies such as DP&P offer a marked improvement over pure paper-based systems and seem likely to play an increasingly important role in clinical trials.   l

Andrew Mackenzie is the R&D Manager of Digital Pen and Paper at Hewlett-Packard. E-mail:

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