Clinical trials using digital pen-and-paper technology are less taxing for investigators than those using more traditional forms of electronic data capture (EDC), according to Massimo Raineri, head of systems development, biometry, at Switzerland-based Actelion Pharmaceuticals. The reason is threefold: Investigators aren’t reduced to being data entry clerks, have nothing new to learn, and are neither anchored to a computer nor distracted by the task of finding letters on a keyboard during patient visits.

 “Most investigators don’t like EDC,” says Raineri. “They feel that having a computer in front of them…changes the way they behave and the structure of [patient] visits. They want to be free to talk and walk and look patients in the eye.” Because they can’t, visits tend to run long and leave patients feeling somewhat neglected.

Raineri knows of what he speaks. Actelion started investigating digital pen-and-paper systems in 2003, and two years later became the first pharmaceutical company to test the technology in small Phase I trials in Germany. Since April 2005, the company has been utilizing the technology for all of its Phase II, III and IV trials. It currently has 700 of the reusable devices in use for 10 trials across Western and Eastern Europe and in the U.S., Israel, and Australia.

The technology, invented by the Sweden-based Anoto Group, requires nothing of investigators beyond what they would do with a standard paper-based case report form (CRF), says Raineri. An infrared camera in the digital pen reads small gray dots invisibly embedded in the digital paper, capturing CRF data as well as the identity of the person entering it and time of note-taking.

Each pen has a unique identifier assigned to a particular investigator or study monitor, says Raineri. The CRF form includes a large area for investigators to write in and a smaller area for monitors to tick check boxes about the information, including source data verification. To alter notes, investigators simply cross out their original entry and write in the correct data alongside it – per Actelion’s working instructions when regular pen and paper are used.

In implementing the technology, says Raineri, “our requirement was to keep the work of investigators exactly the same as without the digital pen. Once investigators have filled out one or more CRFs, the pen is put into a cradle [a kind of docking station on a personal computer] that sends all information directly to Actelion.” There is nothing more for them to do…until the monitor visits the site.”

When the technology is used in less complex post-marketing surveillance studies, says Raineri, investigators get immediate feedback on needed data corrections the moment the digital pen hits the cradle.

Actelion has never used EDC, which captures data “within seconds or minutes versus minutes or hours” with digital pen and paper, says Raineri. One technology or the other is necessary to accomplish adaptive clinical trials, in which data is needed early and continuously throughout the life of a study. Actelion has used its digital system in a group sequential trial of an orexin receptor antagonist for insomnia as well as in traditional studies of Tracleer, a drug for pulmonary arterial hypertension.

Soon, Actelion expects to begin testing a new digital pen-and-paper system that includes the option of transmitting data wirelessly via mobile phones, says Raineri. Digital CRFs will include a small “send box” that, when pressed, triggers the connection.

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