By Deb Borfitz
June 22, 2009 | In a recent issue of eCliniqua, investigative sites aired their frustrations with many of the e-clinical technologies embraced by study sponsors. They made particular note of technical deficiencies with electronic data capture (EDC) systems. But, as discussed below, they also offered some solid remedies for improving the situation.
Sponsors building electronic case report forms (eCRFs) in-house might want to start pre-populating data fields with information from subjects’ prior visits, says Diane Palmer, site administrator and clinical research coordinator at New London, Conn.-based Coastal Connecticut Research (CCR). Better yet, site personnel could enter study visit data on a single page.
The Holy Grail of eCRFs would be for the industry as a whole to come up with standards for data entry, she continues. For sites like CCR doing multiple studies, it’s difficult to remember company-specific requirements for inputting information. There are four alternatives for the date format alone: 5/26/2009, 26May2009, 26May09, or 5/26/09. Failure to follow data-entry rules results in automatically generated, time-consuming queries, which steals time from patient recruitment activities.
Palmer declares Phase Forward’s Inform EDC system “one of the best” and worthy of mimicking, including its online training module that includes a printed certificate of completion. Unfortunately, she adds, companies rarely accept the certificate as proof of training for subsequent studies using the same system. She can complete the online test in ten minutes because she knows the answers by heart. Ironically, being a speedy test-taker flags her as a potential cheater in the eyes of some sponsors.
EDC systems as a rule fail to provide the kind of information that could make life easier for sites, such as a study’s enrollment status, according to Richard Litov, director of Pedia Research in Owensboro, KY. Instead, they deliver the intelligence six weeks late via hardcopy newsletters. “Sponsors and CROs can see that information [electronically]. Why not us too?”
Similarly, adds Litov, central lab vendors continue to transmit lab values via fax. In an ideal world, sites would receive lab reports electronically, including a graphic display comparing current and previous lab values of a study subject so investigators don’t have to sift through paper charts to detect important changes. Doing so “would lead to better oversight and evaluation of safety.”
Litov says it would serve sponsors’ interests to involve at least a few sites in the technology acquisition process and then conduct post-study surveys to learn how well a chosen EDC system performs in the real world. “We’ve seen a sponsor switch to a different EDC system for each of three studies conducted in the same program.”
From the standpoint of consistency and accuracy, it would be advantageous for sponsors to provide a standard, study-specific template for source document forms rather than rely on each site to generate their own forms from scratch, especially since these forms mirror the CRFs that are already produced, says Litov. He estimates that Pedia Research donates between 5-20 hours of “secretarial work” per study to create the requisite forms. “Multiply that by 50 or more sites for a multi-center trial and that is a lot of wasted time diverting sites from starting up a study.”
Kelly Walker, chief operating officer at Research Across America (RAA) in Dallas, believes it is time EDC systems were incorporating user-friendly handwriting or voice recognition features. Knowing it could be a long wait, he has taken matters into his own hands by developing a single-data-entry system called DB Pharma, with a programmer familiar with Microsoft tools.
DB Pharma, run off a wireless tablet, utilizes handwriting recognition technology and immediately transmits data to a web host. But it only gets used on a few studies a year, when RAA is responsible for either all of the data capture or all of the data analysis. The system’s only downside, Walker says, is that it doesn’t accommodate doctors’ notoriously sloppy script.