By Steven Engel 

August 13, 2002 | In any clinical trial, gathering accurate, real-time data from patients can be tricky. Ask patients to record their aches and pains, and they may procrastinate or forget. Then, upon driving to their next

The Esendant LogPad has a time and date stamp for each entry from a patient.

doctor's appointment, they'll quickly fill in their diaries, trying to recall symptoms from days or weeks before. This "parking lot" diary, as it is known, may not reflect what patients actually experience. As a result, scientists have expressed skepticism about the results of drug studies based on such data.

Technology may offer a solution. The buzzword is electronic data capture (EDC). An example: Pherin Pharmaceuticals Inc. and ICON Clinical Research are currently in Phase II testing of a compound called PH80, a potential treatment for clinically significant premenstrual syndrome. The companies have given patients standard PDAs to record their experiences in real time — and in a way that is accurate, consistent, and verifiable.

To do the job, Pherin and ICON selected the Esendant LogPad by PHT Corp. Electronic diaries have been around for a while; PHT's twist is the back-end data management system including Web-based review, permissions-based edit, and a full-featured database that allows integration with other data sources and report generation.

The PDA connects through standard dial-up phone lines to a PHT data center for data transfer, data management, and archiving. The time and date stamp for each entry is key: Study coordinators

Wendy Williams, a participant in the study by Pherin Pharmaceuticals and ICON, says using the Esendant LogPad to enter her data was simple.

Once a patient enters the data into the LogPad, she connects the device to the telephone line, and the data are downloaded to the PHT data center. This gives Pherin and the clinical site immediate access to the data and the ability to monitor compliance, something that can take months when such data are processed on paper. The PHT approach also allows the clinician to review patients' symptoms before their visits to the clinic, saving time for busy doctors and nurses.

One of the key requirements for this system was ease of use. Wendy Williams, a patient in the study, enjoyed using the device. The LogPad was "very easy," she says. "There was no room to mess up." An administrator, Faye Biggs, clinical research coordinator for the psychiatry department at the University of Oklahoma, was impressed by the technology: "I only lost one person in this study because of technical difficulties. The others really liked it, even though they weren't computer-savvy."

For Pherin and ICON, the results of using EDC for this trial were positive. The as-yet-unquantified savings they expect to realize on data transcription, data verification, and data management, as well as the time saved by reviewing data before patient visits, are anticipated to cover the costs of the technology. More importantly, the researchers have more confidence in their data. Consider their compliance rate of more than 90 percent. In studies using paper diaries, 40 percent or more of the entries are not made at the times the patients indicated. If PH80 moves on to a Phase III trial, it is clear to the companies involved that EDC will be the preferred way to go.

Steven Engel (sengel@gis.net) is a management consultant.

Back to Clinical Trial Data Management: Tortured by Paper 

PHOTO BY JOHN SMALLWOOD